ETHICON delivers value through a full line of proven products, innovative technology, and responsive business services. PREFACE

his manual has been prepared for the medical professional who Twould like to learn more about the practice of surgery–the dynamics of tissue healing, the principles of wound closure, and the

materials available to today’s practitioners. Most important, it

touches on some of the critical decisions which must be made on a

daily basis to help ensure proper wound closure.

ETHICON PRODUCTS, a Johnson & Johnson company, is the

world’s leading marketer of surgical sutures and is the only U.S.

company that offers an adhesive with microbial protection as an

alternative to sutures for topical skin closure.

ETHICON enjoys a reputation for developing quality products to

enhance the lives of patients and for providing outstanding service

to customers. We hope you find this manual useful. But, above all,

we hope that it reflects our high regard for the men and women

who have chosen the medical profession as a career.

~ ETHICON PRODUCTS ~ CONTRIBUTING EDITOR

David, L. Dunn, M.D., Ph. D. Jay Phillips Professor and Chairman of Surgery, University of Minnesota

We thank Dr. Dunn for his contributions to the Wound Closure

Manual. Dr. Dunn is currently the Jay Phillips Professor and

Chairman of Surgery at the University of Minnesota. This

department has a long-standing tradition and has attained

national and international recognition for excellence in training

academic general surgeons and surgical scientists. He is also the

Division Chief of General Surgery, Head of Surgical Infectious

Diseases, Director of Graduate Studies, and Residency Program

Director of the Department of Surgery.

Dr. Dunn has published over 400 articles and book chapters in the

areas of Surgical Infectious Diseases and Transplantation. He has

received regional and nationwide recognition in several

academic organizations and is a Past-President of the Surgical

Infection Society, the Association for Academic Surgery, the

Minnesota Chapter of the American College of Surgeons, the

Society of University Surgeons and the Society of University

Surgeons Foundation. TABLE OF CONTENTS

WOUND HEALING Knot Tying...... 24 AND MANAGEMENT Knot Security...... 24 1 Knot Tying Techniques Most Often Used ...... 25 The Wound...... 2 Square Knot...... 25 Recovery of Tensile Strength...... 2 Surgeon’s or Friction Knot...... 26 Patient Factors that Affect Wound Healing...... 2 Deep Tie...... 26 Surgical Principles...... 4 Ligation Using a Hemostatic Clamp...... 26 Classification of Wounds...... 5 Instrument Tie...... 26 Types of Wound Healing...... 6 Endoscopic Knot Tying Techniques...... 26 Healing by Primary Intention...... 6 Cutting the Secured Sutures...... 26 Healing by Second Intention...... 7 Suture Removal...... 26 Delayed Primary Closure...... 7 Suture Handling Tips...... 27 Suture Selection Procedure ...... 27 Surgery within the Abdominal Wall Cavity...... 28 THE SUTURE Closing the Abdomen...... 30 2 Closing Contaminated or Infected Wounds...... 40 What is a Suture?...... 10 Personal Suture Preference...... 10 Suture Characteristics...... 11 3 THE SURGICAL NEEDLE Size and Tensile Strength...... 11 Monofilament vs. Multifilament...... 11 Elements of Needle Design ...... 42 Absorbable vs. Nonabsorbable Sutures...... 12 Principles of Choosing a Surgical Needle..... 43 Specific Suturing Materials...... 13 Anatomy of a Needle...... 44 Synthetic Absorbable Sutures...... 14 The Needle Eye...... 45 Nonabsorbable Sutures...... 16 The Needle Body...... 46 Synthetic Nonabsorbable Sutures...... 17 Straight Needle...... 46 Common Suturing Techniques...... 18 Half-Curved Needle...... 46 Ligatures...... 18 Curved Needle...... 46 The Primary Suture Line...... 19 Compound Curved Needle...... 47 Continuous Sutures...... 19 The Needle Point ...... 47 Interrupted Sutures...... 22 Types of Needles...... 47 Deep Sutures...... 22 Conventional Cutting Needles...... 48 Buried Sutures ...... 22 Reverse Cutting Needles...... 49 Purse-String Sutures...... 22 Side Cutting Needles...... 49 Subcuticular Sutures...... 22 Taper Point Needles...... 50 The Secondary Suture Line...... 23 Taper Surgical Needles...... 50 Stitch Placement...... 23 Blunt Point Needles...... 51 Needleholders...... 51 Needleholder Use...... 52 Placing the Needle in Tissue ...... 52 Needle Handling Tips...... 53 PRODUCT TERMS 4 PACKAGING 7 AND TRADEMARKS An Integral Part of the Product ...... 56 RELAY* Suture Delivery System...... 56 Modular Storage Racks...... 56 Dispenser Boxes...... 57 8 PRODUCT INFORMATION Primary Packets...... 57 E-PACK* Procedure Kit...... 59 Expiration Date...... 60 Suture Sterilization...... 60 Anticipating Suture Needs...... 61 INDEX Sterile Transfer of Suture Packets...... 61 9 Suture Preparation in the Sterile Field...... 62 Suture Handling Technique...... 63

5 TOPICAL SKIN ADHESIVES DERMABOND* Topical Skin Adhesive...... 68

OTHER SURGICAL 6 PRODUCTS Adhesive Tapes...... 74 Indications and Usage...... 74 Application...... 74 After Care and Removal...... 74 Skin Closure Tapes...... 75 Polyester Fiber Strip...... 75 Umbilical Tape ...... 75 Surgical Staples...... 75 Indications and Usage...... 76 Aftercare and Removal...... 76 PROXIMATE* Skin Staplers...... 76 Looped Suture...... 77 Retention Suture Devices...... 77 CHAPTER 1

WOUND HEALING AND MANAGEMENT 2 WOUND HEALING & MANAGEMENT

THE WOUND point of rupture, relating to the thickness of tissue, the presence of nature of the material rather than edema, and duration (the degree to Injury to any of the tissues of its thickness. which the tissue has hardened in the body, especially that caused • Breaking Strength—The load response to pressure or injury). by physical means and with required to break a wound regard- interruption of continuity is defined less of its dimension, the more as a wound.1 Though most often PATIENT FACTORS THAT clinically significant measurement. AFFECT WOUND HEALING the result of a physical cause, a • Burst Strength—The amount of The goal of wound management burn is also considered a wound. pressure needed to rupture a is to provide interventions that Both follow the same processes viscus, or large interior organ. towards the restoration to efficiently progress wounds through health – otherwise known The rate at which wounds regain the biologic sequence of repair or as healing.1 strength during the wound healing regeneration. The patient's overall process must be understood as a health status will affect the speed of Wound healing is a natural and basis for selecting the most the healing process. The following spontaneous phenomenon. When appropriate wound closure material. are factors that should be considered tissue has been disrupted so severely by the surgical team prior to and that it cannot heal naturally 2,3,4 RECOVERY OF during the procedure. (without complications or possible TENSILE STRENGTH disfiguration) dead tissue and ✦ AGE — With aging, both skin Tensile strength affects the tissue's foreign bodies must be removed, and muscle tissue lose their tone ability to withstand injury but is infection treated, and the tissue and elasticity. Metabolism also not related to the length of time it must be held in apposition until the slows, and circulation may be takes the tissue to heal. As collagen healing process provides the wound impaired. But aging alone is not accumulates during the reparative with sufficient strength to withstand a major factor in chronic wound phase, strength increases rapidly but stress without mechanical support. healing. Aging and chronic it is many months before a plateau A wound may be approximated disease states often go together, is reached.2 Until this time, the with sutures, staples, clips, skin and both delay repair processes wound requires extrinsic support closure strips, or topical adhesives. due to delayed cellular response from the method used to bring it to the stimulus of injury, delayed Tissue is defined as a collection of together – usually sutures. While collagen deposition, and similar cells and the intercellular skin and fascia (the layer of firm decreased tensile strength in the substances surrounding them. connective tissue covering muscle) remodeled tissue. All of these There are four basic tissues in the are the strongest tissues in the body, factors lengthen healing time. body: 1) epithelium; 2) connective they regain tensile strength slowly tissues, including blood, bone and during the healing process. The ✦ WEIGHT — Obese patients cartilage; 3) muscle tissue; and stomach and small intestine, on the of any age have, excess fat at the 4) nerve tissue. The choice of other hand, are composed of much wound site that may prevent wound closure materials and the weaker tissue but heal rapidly. securing a good closure. In techniques of using them are prime Variations in tissue strength may addition, fat does not have a rich factors in the restoration of also be found within the same blood supply, making it the most continuity and tensile strength to organ. Within the colon, for vulnerable of all tissues to trauma the injured tissues during the example, the sigmoid region is and infection. healing process. approximately twice as strong as the cecum—but both sections heal at ✦ NUTRITIONAL STATUS — The parameters for measuring the the same rate. Factors that affect Overall malnutrition associated strength of normal body tissue are: tissue strength include the size, age, with chronic disease or cancer, • Tensile Strength—The load per and weight of the patient, the or specific deficiencies in cross-sectional area unit at the CHAPTER 1 3

have debilitated immune systems. Some patients have allergies to FIGURE specific suturing materials, metal 1 alloys, or latex. These, on the RELATIVE other hand, will cause a height- TISSUE ened immune response in the STRENGTH form of an allergic reaction. This may also interfere with the healing process. Therefore, Lower respiratory the surgeon should always tract (Weak) Stomach check beforehand on a Duodenum (Weak) patient's allergies. (Strong) Small Cecum intestine ✦ CHRONIC DISEASE — (Weak) (Weak) A patient whose system has Ileum Female already been stressed by chronic (Weak) reproductive organs illness, especially endocrine (Weak) disorders, diabetes, malignancies, Bladder localized infection, or debilitating (Weak) injuries will heal more slowly and will be more vulnerable to post surgical wound complications. All of these conditions merit carbohydrates, proteins, zinc, and healing. Skin healing takes place concern, and the surgeon must vitamins A, B, and C can impair most rapidly in the face and consider their effects upon the the healing process. Adequate neck, which receive the greatest tissues at the wound site, as well nutrition is essential to support blood supply, and most slowly in as their potential impact upon cellular activity and collagen the extremities. The presence of the patient's overall recovery synthesis at the wound site. any condition that compromises from the procedure. the supply of blood to the Malignancies, in addition, may ✦ DEHYDRATION — If the wound, such as poor circulation alter the cellular structure of to the limbs in a diabetic patient patient's system has been tissue and influence the or arteriosclerosis with vascular depleted of fluids, the resulting surgeon's choice of methods and compromise, will slow and can electrolyte imbalance can affect closure materials. cardiac function, kidney even arrest the healing process. function, cellular metabolism, ✦ RADIATION THERAPY — oxygenation of the blood, and ✦ IMMUNE RESPONSES — Radiation therapy to the surgical hormonal function. These effects Because the immune response site prior to or shortly after will not only impact upon the protects the patient from surgery can produce considerable patient's overall health status and infection, immunodeficiencies impairment of healing and lead recovery from surgery but may may seriously compromise the to substantial wound complica- also impair the healing process. outcome of a surgical procedure. tions. Surgical procedures for Patients infected with HIV, as malignancies must be planned ✦ INADEQUATE BLOOD well as those who have recently to minimize the potential for SUPPLY TO THE WOUND undergone chemotherapy or who these problems. SITE — Oxygen is necessary for have taken prolonged high cell survival and, therefore, dosages of catabolic steroids, may

* Trademark 4 WOUND HEALING

SURGICAL PRINCIPLES ✦ DISSECTION tive hematomas. Collections of Many factors that affect the healing TECHNIQUE — When incising blood (hematomas) or fluid process can be controlled by the tissue, a clean incision should (seromas) in the incision can surgical team in the operating room, be made through the skin with prevent the direct apposition of by the obstetrical team in labor and one stroke of evenly applied tissue needed for complete union delivery, or by the emergency team pressure on the scalpel. Sharp of wound edges. Furthermore, in the trauma center. Their first dissection should be used to cut these collections provide an ideal priority is to maintain a sterile through remaining tissues. The culture medium for microbial and aseptic technique to prevent surgeon must preserve the growth and can lead to serious infection. Organisms found integrity of as many of the infection. underlying nerves, blood vessels, within a patient's own body most When clamping or ligating a and muscles as possible. commonly cause postoperative vessel or tissue, care must be infection, but microorganisms taken to avoid excessive tissue ✦ TISSUE HANDLING — carried by medical personnel also damage. Mass ligation that Keeping tissue trauma to a pose a threat. Whatever the source, involves large areas of tissue may minimum promotes faster the presence of infection will deter produce necrosis, or tissue death, healing. Throughout the healing. In addition to concerns and prolong healing time. about sterility, the following must operative procedure, the surgeon be taken into consideration when must handle all tissues very ✦ MAINTAINING MOISTURE gently and as little as possible. planning and carrying out an IN TISSUES — During long 3 Retractors should be placed with operative procedure. procedures, the surgeon may care to avoid excessive pressure, periodically irrigate the wound ✦ THE LENGTH AND since tension can cause serious with warm physiologic (normal) complications: impaired blood DIRECTION OF THE saline solution, or cover exposed and lymph flow, altering of the INCISION — A properly surfaces with saline-moistened local physiological state of the planned incision is sufficiently sponges or laparotomy tapes to wound, and predisposition to long to afford sufficient optimum prevent tissues from drying out. exposure. When deciding upon microbial colonization. the direction of the incision, the ✦ REMOVAL OF NECROTIC ✦ HEMOSTASIS surgeon must bear the following — Various TISSUE AND FOREIGN mechanical, thermal, and in mind: MATERIALS — Adequate chemical methods are available to • The direction in which wounds debridement of all devitalized decrease the flow of blood and naturally heal is from side-to- tissue and removal of inflicted fluid into the wound site. side, not end-to-end. foreign materials are essential Hemostasis allows the surgeon to to healing, especially in traumatic • The arrangement of tissue fibers work in as clear a field as possible wounds. The presence of in the area to be dissected will with greater accuracy. Without fragments of dirt, metal, glass, vary with tissue type. adequate control, bleeding from etc., increases the probability • The best cosmetic results may be transected or penetrated vessels of infection. achieved when incisions are made or diffused oozing on large parallel to the direction of the denuded surfaces may interfere ✦ CHOICE OF CLOSURE tissue fibers. Results may vary with the surgeon's view of MATERIALS — The surgeon depending upon the tissue underlying structures. layer involved. must evaluate each case individu- Achieving complete hemostasis ally, and choose closure material before wound closure also will which will maximize the prevent formation of postopera- opportunity for healing and minimize the likelihood of CHAPTER 1 5

infection. The proper closure the fatty layer which tends to Tendons and the extremities may material will allow the surgeon lack blood supply. Serum or also be subjected to excessive to approximate tissue with as blood may collect, providing an tension during healing. The little trauma as possible, and with ideal medium for the growth surgeon must be certain that enough precision to eliminate of microorganisms that cause the approximated wound is dead space. The surgeon's infection. The surgeon may adequately immobilized to personal preference will play a elect to insert a drain or apply prevent suture disruption large role in the choice of closure a pressure dressing to help for a sufficient period of time material; but the location of the eliminate dead space in the after surgery. wound, the arrangement of tissue wound postoperatively. fibers, and patient factors influ- ✦ IMMOBILIZATION — ence his or her decision as well. ✦ CLOSING TENSION — Adequate immobilization of the While enough tension must be approximated wound, but not ✦ CELLULAR RESPONSE TO applied to approximate tissue and necessarily of the entire anatomic CLOSURE MATERIALS — eliminate dead space, the sutures part, is mandatory after surgery Whenever foreign materials such must be loose enough to prevent for efficient healing and minimal as sutures are implanted in tissue, exaggerated patient discomfort, scar formation. the tissue reacts. This reaction ischemia, and tissue necrosis will range from minimal to during healing. moderate, depending upon the CLASSIFICATION type of material implanted. The ✦ POSTOPERATIVE reaction will be more marked if DISTRACTION FORCES — OF WOUNDS complicated by infection, allergy, The patient's postoperative The Centers for Disease Control or trauma. activity can place undue stress and Prevention (CDC), using an upon a healing incision. adaptation of the American College Initially, the tissue will deflect the Abdominal fascia will be placed of Surgeons’ wound classification passage of the surgeon's needle under excessive tension after schema, divides surgical wounds and suture. Once the sutures surgery if the patient strains to into four classes: clean wounds, have been implanted, edema of cough, vomit, void, or defecate. clean-contaminated wounds, the skin and subcutaneous tissues will ensue. This can cause significant patient discomfort during recovery, as well as FIGURE scarring secondary to ischemic 2 necrosis. The surgeon must take these factors into consideration DEAD SPACE IN A WOUND when placing tension upon the closure material.

✦ ELIMINATION OF DEAD SPACE IN THE WOUND — Dead space in a wound results from separation of portions of the wound beneath the skin edges which have not been closely approximated, or from air or fluid trapped between layers of tissue. This is especially true in * Trademark 6 WOUND HEALING

contaminated wounds and dirty or contaminated by entry into a HEALING BY infected wounds.5 A discussion of viscus resulting in minimal spillage PRIMARY INTENTION each follows. of contents. Every surgeon who closes a wound would like it to heal by primary Seventy-five percent of all wounds Contaminated wounds include union or first intention, with (which are usually elective surgical open, traumatic wounds or injuries minimal edema and no local incisions) fall into the clean wounds such as soft tissue lacerations, open infection or serious discharge. An category—an uninfected operative fractures, and penetrating wounds; incision that heals by primary wound in which no inflammation operative procedures in which gross intention does so in a minimum of is encountered and the respiratory, spillage from the gastrointestinal time, with no separation of the alimentary, genital, or uninfected tract occurs; genitourinary or biliary wound edges, and with minimal urinary tracts are not entered. tract procedures in the presence scar formation. This takes place in These elective incisions are made of infected urine or bile; and three distinct phases:2,3 under aseptic conditions and are operations in which a major break not predisposed to infection. in aseptic technique has occurred Inflammatory (preparative) – Inflammation is a natural part of (as in emergency open cardiac During the first few days, an the healing process and should be massage). Microorganisms inflammatory response causes an differentiated from infection in multiply so rapidly that within outpouring of tissue fluids, an which bacteria are present and 6 hours a contaminated wound accumulation of cells and produce damage. can become infected. fibroblasts, and an increased blood supply to the wound. Leukocytes Clean wounds are closed by primary Dirty and infected wounds have and other cells produce proteolytic union and usually are not drained. been heavily contaminated or enzymes which dissolve and remove Primary union is the most desirable clinically infected prior to the damaged tissue debris. These are method of closure, involving the operation. They include perforated the responses which prepare the site simplest surgical procedures and viscera, abscesses, or neglected of injury for repair. The process the lowest risk of postoperative traumatic wounds in which lasts 3 to 7 days. Any factor which complications. Apposition of tissue devitalized tissue or foreign material interferes with the progress, may is maintained until wound tensile have been retained. Infection interrupt or delay healing. During strength is sufficient so that sutures present at the time of surgery can the acute inflammatory phase, the or other forms of tissue apposition increase the infection rate of any tissue does not gain appreciable are no longer needed. wound by an average of four times. tensile strength, but depends solely Clean-contaminated wounds are upon the closure material to hold it operative wounds in which the in approximation. respiratory, alimentary, genital, or TYPES OF Proliferative – After the urinary tracts are entered under WOUND HEALING debridement process is well along, controlled conditions and without The rate and pattern of healing falls fibroblasts begin to form a collagen unusual contamination. Specifically, into three categories, depending matrix in the wound known as operations involving the biliary upon the type of tissue involved granulation tissue. Collagen, a tract, appendix, vagina, and and the circumstances surrounding protein substance, is the chief oropharynx are included in this closure. Timeframes are generalized constituent of connective tissue. category provided no evidence for well-perfused healthy soft Collagen fiber formation determines of infection or major break in tissues, but may vary. the tensile strength and pliability of technique is encountered. the healing wound. As it fills with Appendectomies, cholecystectomies, new blood vessels, the granulation and hysterectomies fall into this becomes bright, beefy, red tissue. category, as well as normally The thick capillary bed which fills clean wounds which become CHAPTER 1 7

Damaged tissue debris Tissue fluids FIGURE 3

PHASES OF WOUND HEALING Proteolytic Fibroblasts enzymes

Increased blood supply Collagen fibers PHASE 1– PHASE 2– PHASE 3– Inflammatory response and Collagen formation Sufficient collagen laid down debridement process (scar tissue) the matrix, supplies the nutrients Remodelling – As collagen deposi- DELAYED PRIMARY and oxygen necessary for the wound tion is completed, the vascularity of CLOSURE to heal. This phase occurs from the wound gradually decreases and This is considered by many day 3 onward. any surface scar becomes paler. The surgeons to be a safe method of amount of collagen that is finally management of contaminated, as In time, sufficient collagen is laid formed – the ultimate scar – is well as dirty and infected traumatic down across the wound so that it dependent upon the initial volume wounds with extensive tissue loss can withstand normal stress. The of granulation tissue.2 and a high risk of infection. This length of this phase varies with the method has been used extensively in type of tissue involved and the HEALING BY the military arena and has proven stresses or tension placed upon the SECOND INTENTION successful following excessive wound during this period. When the wound fails to heal by trauma related to motor vehicle Wound contraction also occurs dur- primary union, a more complicated accidents, shooting incidents, or ing this phase. Wound contraction and prolonged healing process takes infliction of deep, penetrating is a process that pulls the wound place. Healing by second intention knife wounds.3 edges together for the purpose of is caused by infection, excessive The surgeon usually treats these closing the wound. In essence, it trauma, tissue loss, or imprecise injuries by debridement of reduces the open area, and if approximation of tissue.3 nonviable tissues and leaves the successful, will result in a smaller In this case, the wound may be left wound open, inserting gauze wound with less need for repair by open and allowed to heal from the packing which is changed twice a scar formation. Wound contraction inner layer to the outer surface. day. Patients sedation or a return to can be very beneficial in the closure Granulation tissue forms and the operating room with general of wounds in areas such as the but- contains myofibroblasts. These anesthesia generally is only required tocks or trochanter but can be very specialized cells help to close the in the case of large, complex harmful in areas such as the hand wound by contraction. This wounds. Wound approximation or around the neck and face, where process is much slower than primary using adhesive strips, previously it can cause disfigurement and intention healing. Excessive placed but untied sutures, staples excessive scarring.3 granulation tissue may build up after achieving local anesthesia can Surgical wounds that are closed and require treatment if it protrudes occur within 3-5 days if the wound by primary intention have minimal above the surface of the wound, demonstrates no evidence of contraction response. Skin grafting preventing epithelialization. infection and the appearance of red is used to reduce avoided contrac- granulation tissue. Should this not tion in undesirable locations. * Trademark 8 WOUND HEALING

occur, the wound is allowed to heal by secondary intention. When closure is undertaken, skin edges and underlying tissue must be accu- rately and securely approximated.

IN THE NEXT SECTION The materials, devices, and techniques used to repair wounded tissue will be discussed at length. As you will see, the number of options available is extensive. But no matter how many choices the surgeon has, his or her objective remains singular: to restore the patient to health with as little operative trauma as possible and an excellent cosmetic result.

REFERENCES 1. Stedman’s Medical Dictionary, 27th edition, 2000 2. Henry, Michael and Thompson, Jeremy: Clinical Surgery, W.B. Saunders, 2001 3. Skerris, David A.: Mayo Clinic Basic Surgery Skills, Mayo Clinic Scientific Press, 1999 4. Sussman, Carrie: Wound Care, Aspen Publishers, 1998 5. NNIS Manual, CDC, MHA, 2000 CHAPTER 2

THE SUTURE 10 THE SUTURE

WHAT IS • They must be secured in A number of factors may influence A SUTURE? packaging which presents them the surgeon’s choice of materials: sterile for use, in excellent The word "suture" describes any condition, and ensures the • His or her area of specialization. strand of material used to ligate (tie) safety of each member of the • Wound closure experience during blood vessels or approximate (bring surgical team. clinical training. close together) tissues. Sutures are • Professional experience in the used to close wounds. Sutures and The nurse must maintain the operating room. ligatures were used by both the sterility of sutures when storing, • Knowledge of the healing Egyptians and Syrians as far back as handling, and preparing them for characteristics of tissues and 2,000 B.C. Through the centuries, a use. The integrity and strength of organs. wide variety of materials—silk, each strand must remain intact • Knowledge of the physical and linen, cotton, horsehair, animal until it is in the surgeon's hands. biological characteristics of tendons and intestines, and wire The surgeon must select suture various suture materials. made of precious metals—have been materials appropriate for the • Patient factors (age, weight, used in operative procedures. Some procedure and must place them overall health status, and the of these are still in use today. in the tissues in a manner consistent presence of infection). The evolution of suturing material with the principles that promote has brought us to a point of refine- wound healing. Surgical specialty plays a primary role in determining suture preference. For ment that includes sutures designed With the manufacturer and for specific surgical procedures. example, obstetrician/gynecologists surgical team working in concert, frequently prefer coated VICRYL* Despite the sophistication of the patient reaps the final RAPIDE (polyglactin 910) suture today's suture materials and surgical benefit...the wound is closed in a for episiotomy repair and coated techniques, closing a wound still manner that promotes optimum VICRYL* (polyglactin 910) suture, involves the same basic procedure healing in minimum time. coated VICRYL* Plus Antibacterial used by physicians to the Roman (polyglactin 910) suture and emperors. The surgeon still uses a MONOCRYL* (poliglecaprone 25) surgical needle to penetrate tissue PERSONAL SUTURE suture for all tissue layers except, and advance a suture strand to its PREFERENCE possibly skin. Most orthopaedic desired location. surgeons use coated VICRYL suture, Most surgeons have a basic coated VICRYL Plus, PDS* II Successful use of suture materials "suture routine," a preference for depends upon the cooperation of (polydioxanone) suture, and using the same material(s) unless ETHIBOND* EXCEL polyester the suture manufacturer and the circumstances dictate otherwise. surgical team. suture. Many plastic surgeons prefer The surgeon acquires skill, ETHILON* nylon suture, VICRYL The manufacturer must have a proficiency, and speed in handling suture, or MONOCRYL suture. thorough knowledge of surgical by using one suture material Many neurosurgeons prefer coated procedures, anticipate the surgical repeatedly—and may choose VICRYL suture or NUROLON* team's needs, and produce suture the same material throughout his nylon suture. But no single suture materials that meet these or her entire career. material is used by every surgeon who stringent criteria: practices within a specialty. • They must have the greatest tensile strength consistent with The surgeon's knowledge of the size limitations. physical characteristics of suture • They must be easy to handle. material is important. As the requirements for wound support vary with patient factors, the nature of the CHAPTER 2 11

procedure, and the type of tissue SIZE AND TENSILE MONOFILAMENT VS. involved, the surgeon will select STRENGTH MULTIFILAMENT STRANDS suture material that will retain its Size denotes the diameter of the Sutures are classified according to strength until the wound heals suture material. The accepted the number of strands of which sufficiently to withstand stress on surgical practice is to use the they are comprised. Monofilament its own. smallest diameter suture that sutures are made of a single strand will adequately hold the mending of material. Because of their SUTURE wounded tissue. This practice simplified structure, they encounter CHARACTERISTICS minimizes trauma as the suture is less resistance as they pass passed through the tissue to effect through tissue than multifilament The choice of suture materials gen- closure. It also ensures that the suture material. They also resist erally depends on whether the minimum mass of foreign material harboring organisms which may wound closure occurs in one or is left in the body. Suture size is cause infection. more layers. In selecting the most stated numerically; as the number of These characteristics make appropriate sutures, the surgeon 0s in the suture size increases, the monofilament sutures well-suited takes into account the amount of diameter of the strand decreases. For to vascular surgery. Monofilament tension on the wound, the number example, size 5-0, or 00000, is sutures tie down easily. However, of layers of closure, depth of suture smaller in diameter than size 4-0, or because of their construction, placement, anticipated amount of 0000. The smaller the size, the less extreme care must be taken when edema, and anticipated timing of tensile strength the suture will have. suture removal. handling and tying these sutures. Knot tensile strength is measured by Crushing or crimping of this suture Optimal suture qualities include: the force, in pounds, which the type can nick or create a weak spot suture strand can withstand before in the strand. This may result in 1. High uniform tensile strength, it breaks when knotted. The tensile suture breakage. permitting use of finer sizes. strength of the tissue to be mended 2. High tensile strength retention Multifilament sutures consist of (its ability to withstand stress) in vivo, holding the wound several filaments, or strands, twisted determines the size and tensile securely throughout the critical or braided together. This affords strength of the suturing material the healing period, followed by greater tensile strength, pliability, and surgeon selects. The accepted rule is rapid absorption. flexibility. Multifilament sutures may that the tensile strength of the 3. Consistent uniform diameter. also be coated to help them pass rela- suture need never exceed the tensile 4. Sterile. tively smoothly through tissue and strength of the tissue. However, 5. Pliable for ease of handling and enhance handling characteristics. sutures should be at least as strong knot security. Coated multifilament sutures are as normal tissue through which they 6. Freedom from irritating well-suited to intestinal procedures. are being placed. substances or impurities for optimum tissue acceptance. 7. Predictable performance. METRIC MEASURES AND U.S.P. SUTURE DIAMETER EQUIVALENTS TABLE 1

U.S.P. Size 11-0 10-0 9-0 8-0 7-0 6-0 5-0 4-0 3-0 2-0 0 1 2 3 4 5 6

Natural Collagen ––– 0.2 0.3 0.5 0.7 1.0 1.5 2.0 3.0 3.5 4.0 5.0 6.0 7.0 8.0 ––– –––

Synthetic Absorbables ––– 0.2 0.3 0.4 0.5 0.7 1.0 1.5 2.0 3.0 3.5 4.0 5.0 6.0 6.0 7.0 –––

Nonabsorbable Materials 0.1 0.2 0.3 0.4 0.5 0.7 1.0 1.5 2.0 3.0 3.5 4.0 5.0 6.0 6.0 7.0 8.0 * Trademark 12 THE SUTURE

ABSORBABLE VS. NONABSORBABLE SUTURES SUTURE RAW MATERIAL Sutures are classified according to their degradation properties. Surgical Gut Submucosa of sheep TABLE Plain intestine or serosa of beef 2 Sutures that undergo rapid degrada- Chromic intestine tion in tissues, losing their tensile Fast Absorbing ABSORBABLE strength within 60 days, are SUTURES: Polyglactin 910 Copolymer of glycolide and considered absorbable sutures. Uncoated (VICRYL Suture) lactide with polyglactin 370 BASIC RAW and calcium stearate, if coated MATERIALS Sutures that generally maintain Coated (coated VICRYL their tensile strength for longer than (polyglactin 910) suture, 60 days are nonabsorbable sutures. coated VICRYL Plus suture, coated VICRYL* RAPIDE Absorbable sutures may be used to (polyglactin 910) suture) hold wound edges in approximation Polyglycolic Acid Homopolymer of glycolide temporarily, until they have healed Poliglecaprone 25 Copolymer of glycolide and sufficiently to withstand normal (MONOCRYL suture) epsilon-caprolactone stress. These sutures are prepared either from the collagen of healthy Polyglyconate Copolymer of glycolide and mammals or from synthetic trimethylene carbonate polymers. Some are absorbed Polydioxanone Polyester of poly (p-dioxanone) rapidly, while others are treated or (PDS* II suture) chemically structured to lengthen absorption time. They may also be impregnated or coated with agents considerable overlap, characterized causing too rapid a decline in tensile that improve their handling by loss of suture mass. Both stages strength. In addition, if the sutures properties, and colored with an exhibit leukocytic cellular responses become wet or moist during FDA-approved dye to increase which serve to remove cellular handling, prior to being implanted visibility in tissue. Natural debris and suture material from the in tissue, the absorption process absorbable sutures are digested by line of tissue approximation. may begin prematurely. Similarly, body enzymes which attack and patients with impaired healing break down the suture strand. The loss of tensile strength and are often not ideal candidates Synthetic absorbable sutures are the rate of absorption are separate for this type of suture. All of hydrolyzed—a process by which phenomena. A suture can lose these situations predispose to water gradually penetrates the tensile strength rapidly and yet be postoperative complications, as suture filaments, causing the absorbed slowly—or it can the suture strand will not maintain breakdown of the suture's polymer maintain adequate tensile strength adequate strength to withstand chain. Compared to the enzymatic through wound healing, followed stress until the tissues have action of natural absorbables, by rapid absorption. In any case, healed sufficiently. hydrolyzation results in a lesser the strand is eventually completely degree of tissue reaction following dissolved, leaving no detectable Nonabsorbable sutures are those implantation. traces in tissue. which are not digested by body enzymes or hydrolyzed in body During the first stage of the Although they offer many tissue. They are made from a variety absorption process, tensile strength advantages, absorbable sutures also of nonbiodegradable materials and diminishes in a gradual, almost have certain inherent limitations. are ultimately encapsulated or linear fashion. This occurs over the If a patient has a fever, infection, walled off by the body’s fibroblasts. first several weeks postimplantation. or protein deficiency, the suture Nonabsorbable sutures ordinarily The second stage often follows with absorption process may accelerate, remain where they are buried CHAPTER 2 13 within the tissues. When used for SUTURE RAW MATERIAL skin closure, they must be removed postoperatively. Nonabsorbable Surgical Silk Raw silk spun by silkworm TABLE 3 sutures may be used in a variety Stainless Steel Wire Specially formulated of applications: iron-chromium-nickel- NON- molybdenum alloy • Exterior skin closure, to be ABSORBABLE SUTURES: RAW removed after sufficient healing Nylon (ETHILON* nylon Polyamide polymer suture, NUROLON* nylon MATERIALS has occurred. suture) • Within the body cavity, where they will remain permanently Polyester Fiber Polymer of polyethylene Uncoated (MERSILENE* terephthalate (may be coated) encapsulated in tissue. polyester fiber suture) • Patient history of reaction to Coated (ETHIBOND* EXCEL absorbable sutures, keloidal polyester suture tendency, or possible tissue Polypropylene (PROLENE* Polymer of propylene hypertrophy. polypropylene suture) • Prosthesis attachment Poly(hexafluoropropylene-VDF) Polymer blend of poly(vinylidene (i.e., defibrillators, pacemakers, (PRONOVA* poly(hexafluoro- fluoride) and poly(vinylidene fluo- drug delivery mechanisms). propylene-VDF) suture) ride-cohexafluoropropylene) Nonabsorbable sutures are com- posed of single or multiple filaments Absorbable Sutures maximum limits on diameter for of metal, synthetic, or organic fibers Surgical Gut each size. The ETHICON exclusive rendered into a strand by spinning, Absorbable surgical gut is classified TRU-GAUGING process produces twisting, or braiding. Each strand is as either plain or chromic. Both a uniform diameter to within an substantially uniform in diameter types consist of processed strands of accuracy of 0.0002 inch throughout its length, conforming highly purified collagen. The (0.0175mm) along the entire to the United States Pharmacopeia percentage of collagen in the suture length of every strand, eliminating (U.S.P.) limitations for each size. determines its tensile strength and high and low spots. High and low Nonabsorbable sutures have been its ability to be absorbed by the spots can cause the suture to fray classified by the U.S.P. according to body without adverse reaction. or chatter when knots are tied their composition. In addition, Noncollagenous material can cause down, resulting in a knot that is these sutures may be uncoated a reaction ranging from irritation to not positioned properly or tied or coated, uncolored, naturally rejection of the suture. The more securely. Most protein-based colored, or dyed with an FDA- pure collagen throughout the absorbable sutures have a tendency approved dye to enhance visibility. length of the strand, the less foreign to fray when tied. material there is introduced into TRU-GAUGING ensures that the wound. ETHICON surgical gut sutures SPECIFIC SUTURING ETHICON* surgical gut sutures are possess uniform high tensile MATERIALS manufactured from between 97% strength, virtually eliminating the and 98% pure ribbons of collagen. possibility of fray or breaking. Their The materials and products To meet U.S.P. specifications, unexceeded strength and surface described here embody the most processed ribbons of the submucosa smoothness allow the surgeon to current advances in the manufacture layer of sheep intestine or the "snug down" the suture knot to of surgical sutures. They are serosa layer of beef intestine are achieve optimum tension. grouped as either absorbable or electronically spun and polished The rate of absorption of surgical nonabsorbable for easy reference. into virtually monofilament strands gut is determined by the type of of various sizes, with minimum and

* Trademark 14 THE SUTURE

gut being used, the type and during the early stages of wound ligation, in ophthalmic, cardiovascu- condition of the tissue involved, healing. Tensile strength may be lar, or neurological procedures, and the general health status of the retained for 10 to 14 days, with where extended approximation of patient. Surgical gut may be used in some measurable strength remaining tissues under stress is required, or the presence of infection, although for up to 21 days. where wound support beyond 7 it may be absorbed more rapidly days is required. under this condition. SYNTHETIC Coated VICRYL RAPIDE sutures ABSORBABLE SUTURES Plain surgical gut is rapidly retain approximately 50% of the Synthetic absorbable sutures offer the absorbed. Tensile strength is original tensile strength at 5 days strength needed for a wide range of maintained for only 7 to 10 days postimplantation. All of the original applications, from abdominal and postimplantation, and absorption tensile strength is lost by approxi- chest wound closure to ophthalmic is complete within 70 days. The mately 10 to 14 days. Absorption is and plastic surgery. surgeon may choose plain gut for essentially complete by 42 days. use in tissues which heal rapidly COATED VICRYL* RAPIDE Coated VICRYL RAPIDE suture and require minimal support (for (POLYGLACTIN 910) SUTURE is particularly well-suited for skin example, ligating superficial blood This braided suture is composed of closure, episiotomy repair, and vessels and suturing subcutaneous the same copolymer as coated closure of lacerations under casts. fatty tissue). Plain surgical gut can VICRYL suture—lactide and In addition, since the suture begins also be specially heat-treated to glycolide—and is coated with a to "fall off" in 7 to 10 days as the accelerate tensile strength loss and combination of equal parts of wound heals, the need for suture absorption. This fast absorbing copolymer of lactide and glycolide removal is eliminated. surgical gut is used primarily for (polyglactin 370) and calcium epidermal suturing where sutures stearate. However, the absorption MONOCRYL* are required for only 5 to 7 days. rate and tensile strength profile are (POLIGLECAPRONE 25) SUTURE These sutures have less tensile significantly different from coated This monofilament suture strength than plain surgical gut VICRYL suture, achieved by the use features superior pliability for easy of the comparable U.S.P. size. Fast of a polymer material with a lower handling and tying. Comprised absorbing plain gut is not to be molecular weight than coated of a copolymer of glycolide and used internally. VICRYL suture. Coated VICRYL epsilon-caprolactone, it is virtually Chromic gut is treated with a RAPIDE sutures are only available inert in tissue and absorbs chromium salt solution to resist undyed. predictably. The surgeon may prefer MONOCRYL sutures for body enzymes, prolonging Coated VICRYL RAPIDE suture absorption time over 90 days. procedures which require high is the fastest-absorbing synthetic initial tensile strength diminishing The exclusive CHROMICIZING suture and exhibits characteristics process used by ETHICON over 2 weeks postoperatively. These that model the performance of include subcuticular closure and thoroughly bathes the pure collagen surgical gut suture. However, ribbons in a buffered chrome soft tissue approximations and being a synthetic material. Coated ligations, with the exception of tanning solution before spinning VICRYL RAPIDE suture elicits into strands. After spinning, the neural, cardiovascular, ophthalmic, a lower tissue reaction than chromic and microsurgical applications. entire cross section of the strand gut suture. Coated VICRYL is evenly chromicized. The process RAPIDE suture is indicated only MONOCRYL suture is available alters the coloration of the surgical for use in superficial soft tissue dyed (violet) and undyed (natural). gut from yellowish-tan to brown. approximation of the skin and Dyed MONOCRYL suture retains Chromic gut sutures minimize mucosa, where only short-term 60% to 70% of its original strength tissue irritation, causing less wound support (7 to 10 days) at 7 days postimplantation, reduced reaction than plain surgical gut is required. It is not to be used in to 30% to 40% at 14 days, with all CHAPTER 2 15 original strength lost by 28 days. VICRYL suture is essentially Staphylococcus epidermidis (MRSE).3 At 7 days, undyed MONOCRYL complete between 56 and 70 days. In vivo studies demonstrate that suture retains approximately 50% VICRYL Plus Antibacterial suture Lactide and glycolide acids are to 60% of its original strength, and has no adverse effect on normal readily eliminated from the body, approximately 20% to 30% at wound healing.2 primarily in urine. As with 14 days postimplantation. All of uncoated sutures, coated VICRYL Coated VICRYL Plus Antibacterial the original tensile strength of sutures elicit only a mild tissue suture performs and handles the same undyed MONOCRYL suture is reaction during absorption. Their as Coated VICRYL suture. Coated lost by 21 days postimplantation. safety and effectiveness in neural VICRYL Plus Antibacterial suture has Absorption is essentially complete and cardiovascular tissue have not the same dependable construction as at 91 to 119 days. been established. Transcutaneous or Coated VICRYL suture. In vivo COATED VICRYL* conjunctival sutures remaining in testing by surgeons demonstrates the (POLYGLACTIN 910) SUTURE place longer than 7 days may cause same excellence in performance This material fills the need for a localized irritation and should be and handling. removed as indicated. Coated smoother synthetic absorbable The suture is available undyed VICRYL sutures are available as suture that will pass through tissue (natural) or dyed. Coated VICRYL braided dyed violet or undyed readily with minimal drag. Coated Plus suture is indicated for use in natural strands in a variety of VICRYL sutures facilitate ease of general soft tissue approximation lengths with or without needles. handling, smooth tie down and and/or ligation requiring medium unsurpassed knot security. COATED VICRYL support, except for ophthalmic, The coating is a combination of PLUS ANTIBACTERIAL cardiovascular and neurological tissues. equal parts of copolymer of lactide (POLYGLACTIN 910) SUTURE Frequent uses include general closure, and glycolide (polyglactin 370), This synthetic, absorbable, sterile, sur- bowel, orthopedic, and plastic surgery. gical suture is a copolymer made from plus calcium stearate which is Coated VICRYL Plus Antibacterial 90% glycolide and 10% L-lactide. used extensively in pharmaceuticals suture retains approximately 75% of Coated VICRYL Plus Antibacterial and food. Calcium stearate is a salt the original tensile strength at two Suture is coated with a mixture com- of calcium and stearic acid, both weeks post implantation. At three posed of equal parts of copolymer of of which are present in the body weeks, approximately 50% of the glycolide and lactide (polyglactin 370) and constantly metabolized and original strength is retained. At four and calcium stearate. Coated VICRYL excreted. The result of this mixture weeks, approximately 25% of the Plus Antibacterial suture contains is an outstandingly absorbable, original strength is retained. IRGACARE MP*, one of the adherent, nonflaking lubricant. All of the original tensile strength is purest forms of the broad-spectrum lost by five weeks post implantation. At 2 weeks postimplantation, antibacterial agent triclosan. approximately 75% of the tensile Absorption of Coated VICRYL Plus strength of coated VICRYL suture Coated VICRYL Plus Antibacterial Antibacterial Suture is essentially remains. Approximately 50% of suture offers protection against complete between 56 and 70 days. tensile strength is retained at 3 bacterial colonization of the suture. weeks for sizes 6-0 and larger. At 3 In vivo studies demonstrate that PDS* II (POLYDIOXANONE) weeks, 40% of tensile strength is Coated VICRYL Plus Antibacterial SUTURE retained for sizes 7-0 and smaller. At suture has a zone of inhibition that Comprised of the polyester poly 4 weeks, 25% of the original is effective against the pathogens that (p-dioxanone), this monofilament strength is retained for sizes 6-0 and most often cause surgical site infection represents a significant advance larger. All of the original tensile (SSI) – Staphylococcus aureus, in suturing options. It combines strength is lost by five weeks post methicillin-resistant Staphylococcus the features of soft, pliable, implantation. Absorption of coated aureus (MRSA), Staphylococcus monofilament construction with epidermidis, methicillin-resistant absorbability and extended wound * Trademark 16 THE SUTURE

support for up to 6 weeks. It elicits especially due to its superior cannot be detected in tissue after only a slight tissue reaction. This handling characteristics. Silk 2 years. Thus, it behaves in reality material is well-suited for many filaments can be twisted or braided, as a very slowly absorbing suture. types of soft tissue approximation, the latter providing the best including pediatric cardiovascular, handling qualities. SURGICAL STAINLESS STEEL orthopaedic, gynecologic, The essential qualities of surgical Raw silk is a continuous filament ophthalmic, plastic, digestive, stainless steel sutures include the spun by the silkworm moth larva and colonic surgeries. absence of toxic elements, flexibility, to make its cocoon. Cream or and fine wire size. Both monofila- Like other synthetic absorbable orange-colored in its raw state, each ment and twisted multifilament sutures, PDS II sutures are silk filament is processed to remove varieties are high in tensile strength, absorbed in vivo through hydrolysis. natural waxes and sericin gum, low in tissue reactivity, and hold Approximately 70% of tensile which is exuded by the silkworm as a knot well. Provided that the strength remains 2 weeks it spins its cocoon. The gum holds sutures do not fragment, there is postimplantation, 50% at 4 weeks, the cocoon together, but is of no little loss of tensile strength in and 25% at 6 weeks. Absorption is benefit to the quality of braided tissues. The 316L (low carbon) minimal until about the 90th day surgical silk sutures. stainless steel alloy formula used postoperatively and essentially ETHICON degums the silk for in the manufacture of these complete within 6 months. The most suture sizes before the sutures offers optimum metal safety and effectiveness of PDS II braiding process. This allows for a strength, flexibility, uniformity, sutures in microsurgery, neural tighter, more compact braid which and compatibility with stainless tissue, and adult cardiovascular significantly improves suture quality. steel implants and prostheses. tissue have not been established. After braiding, the strands are dyed, Stainless steel sutures may also be PDS II sutures are available clear scoured and stretched, and then used in abdominal wall closure, or dyed violet to enhance visibility. impregnated and coated with a sternum closure, retention, skin mixture of waxes or silicone. Each closure, a variety of orthopaedic of these steps is critical to the procedures, and neurosurgery. NONABSORBABLE SUTURES quality of the finished suture and The U.S.P. classifies nonabsorbable Disadvantages associated with must be carried out in precise order. surgical sutures as follows: alloy sutures include difficulty in Surgical silk is usually dyed black handling; possible cutting, pulling, • CLASS I—Silk or synthetic fibers for easy visibility in tissue. of monofilament, twisted, or and tearing of the patient's tissue; braided construction. Raw silk is graded according to fragmentation; barbing; and • CLASS II—Cotton or linen strength, uniformity of filament kinking, which renders the stainless fibers, or coated natural or diameter, and freedom from defects. steel suture useless. When used for synthetic fibers where the coating Only top grades of silk filaments are bone approximation and fixation, contributes to suture thickness used to produce PERMA-HAND* asymmetrical twisting of the wire without adding strength. surgical silk sutures. will lead to potential buckling, wire fracture, or subsequent wire • CLASS III—Metal wire of Surgical silk loses tensile strength fatigue. Incomplete wire fixation monofilament or multifilament when exposed to moisture and under these circumstances will construction. should be used dry. Although silk permit movement of the wire, is classified by the U.S.P. as a resulting in postoperative pain SURGICAL SILK nonabsorbable suture, long-term and possible dehiscence. For many surgeons, surgical silk in vivo studies have shown that it represents the standard handling loses most or all of its tensile Surgical stainless steel sutures performance by which newer strength in about 1 year and usually should not be used when a synthetic materials are judged, prosthesis of another alloy is CHAPTER 2 17

DIAMETER U.S.P. B & S known as "memory"). Therefore, more throws in the knot are .0031 inch 6-0 40 TABLE required to securely hold monofila- 4 .0040 6-0 38 ment than braided nylon sutures. .0056 5-0 35 SURGICAL Monofilament nylon in a wet or .0063 4-0 34 STAINLESS damp state is more pliable and .0080 4-0 32 STEEL: WIRE GAUGE easier to handle than dry nylon. A .0100 3-0 30 EQUIVALENTS limited line of ETHILON sutures .0126 2-0 28 (sizes 3-0 through 6-0) are pre- .0159 0 26 moistened or "pliabilized" for use .0179 1 25 in cosmetic plastic surgery. This .0201 2 24 process enhances the handling and knot tying characteristics to .0226 3 23 approximate that of braided sutures. .0253 4 22 .0320 5 20 ETHILON sutures are frequently .0360 6 19 used in ophthalmology and micro-surgery procedures in very .0400 7 18 fine sizes. For this reason, sizes 9-0 and 10-0 have an intensified black implanted since an unfavorable SYNTHETIC dye for high visibility. electrolytic reaction may occur. NONABSORBABLE SUTURES Nylon sutures are a polyamide poly- Above all, stainless steel sutures NUROLON* NYLON SUTURE mer derived by chemical synthesis. pose a safety risk. They easily tear This suture is composed of filaments Because of their elasticity, they are surgical gloves when handled of nylon that have been tightly particularly well-suited for retention and may puncture the surgeon's braided into a multifilament strand. and skin closure. They may be own skin—putting both Available in white or dyed black, clear, or dyed green or black for physician and patient at risk NUROLON sutures look, feel, and better visibility. of transmitted immunodeficiency handle like silk. However, NUROLON sutures have more virus or hepatitis. Many surgeons ETHILON* NYLON SUTURE refer to wire size by the Brown & strength and elicit less tissue These sutures are extruded into Sharpe (B & S) gauge of 40 reaction than silk. Braided nylon noncapillary single or monofilament (smallest diameter) to 18 (largest may be used in all tissues where strands characterized by high tensile diameter). ETHICON labels multifilament nonabsorbable sutures strength and extremely low tissue surgical stainless steel with both are acceptable. Braided nylon reactivity. They degrade in vivo at a the B & S and U.S.P. diameter size sutures generally lose 15% to 20% rate of approximately 15% to 20% classifications. of their tensile strength per year in per year by hydrolysis. ETHILON tissue by hydrolyzation. ETHICON packaging of surgical sutures in sizes 10-0 and 6-0 and stainless steel maintains the integrity larger are produced from a special Polyester fiber suture is comprised of the product by eliminating kink- grade of nylon 6. The medical grade of untreated fibers of polyester ing and bending of strands. Just as polyamide nylon 6-6 is used for (polyethylene terephthalate) closely important, it presents the strands in sizes 7-0 and finer. While both braided into a multifilament strand. a safe manner for all members of grades permit good handling, They are stronger than natural the surgical team who handle them. monofilament nylon sutures have a fibers, do not weaken when wetted tendency to return to their original prior to use, and cause minimal straight extruded state (a property tissue reaction. Available white or

* Trademark 18 THE SUTURE

dyed green, polyester fiber sutures Pledgets are used routinely in valve (vinylidene fluoride-cohexafluoro- are among the most acceptable for replacement procedures (to prevent propylene). This suture resists vascular synthetic prostheses. the annulus from tearing when the involvement in infection and has prosthetic valve is seated and the been successfully employed in MERSILENE* POLYESTER sutures are tied), and in situations contaminated and infected wounds FIBER SUTURE where extreme deformity, distortion, to eliminate or minimize later sinus The first synthetic braided suture or tissue destruction at the annulus formation and suture extrusion. material shown to last indefinitely has occurred. Furthermore, the lack of adherence in the body, MERSILENE sutures to tissues has facilitated the use Polypropylene is an isostatic provide precise, consistent suture of PRONOVA suture as a crystalline stereoisomer of a tension. They minimize breakage pull-out suture. and virtually eliminate the need to linear hydrocarbon polymer remove irritating suture fragments permitting little or no saturation. This material is well-suited for postoperatively. Because it is Manufactured by a patented many types of soft tissue approxi- uncoated, MERSILENE suture process which enhances pliability mation and ligation, including use has a higher coefficient of friction and handling, polypropylene in cardiovascular, ophthalmic and when passed through tissue. monofilament sutures are not neurological procedures. subject to degradation or weakening Table 5 gives an overview of the ETHIBOND* EXCEL by tissue enzymes. They cause many suturing options that have POLYESTER SUTURE minimal tissue reaction and hold been discussed in this section. ETHIBOND EXCEL sutures are knots better than most other (See attached chart ) uniformly coated with polybutilate, synthetic monofilament materials. a biologically inert, nonabsorbable compound which adheres itself to PROLENE* POLYPROPYLENE COMMON the braided polyester fiber strand. SUTURE SUTURING Polybutilate was the first synthetic Widely used in general, cardiovascu- TECHNIQUES coating developed specifically as a lar, plastic, and orthopaedic surgery, surgical suture lubricant. The coat- PROLENE sutures do not adhere to LIGATURES ing eases the passage of the braided tissue and are therefore efficacious A suture tied around a vessel to strands through tissue and provides as a pull-out suture. PROLENE occlude the lumen is called a ligature excellent pliability, handling quali- sutures are relatively biologically or tie. It may be used to effect ties, and smooth tie-down with each inert, offering proven strength, hemostasis or to close off a structure throw of the knot. Both the suture reliability and versatility. to prevent leakage. There are two material and the coating are PROLENE sutures are primary types of ligatures. recommended for use where pharmacologically inactive. The Free tie or freehand ligatures are minimal suture reaction is desired, sutures elicit minimal tissue reaction single strands of suture material such as in contaminated and and retain their strength in vivo for used to ligate a vessel, duct, or other infected wounds to minimize extended periods. ETHIBOND* structure. After a hemostat or other later sinus formation and suture EXCEL sutures are used primarily in similar type of surgical clamp has extrusion. They are available clear cardiovascular surgery, for vessel been placed on the end of the or dyed blue. anastomosis, and placement of structure, the suture strand is tied prosthetic materials. PRONOVA* POLY around the vessel under the tip of ETHIBOND EXCEL sutures (HEXAFLUOROPROPYLENE-VDF) the hemostat. The hemostat is are also available attached SUTURE removed after the first throw and to TFE polymer felt pledgets. This monofilament nonabsorbable the surgeon tightens the knot using Pledgets serve to prevent possible suture is a polymer blend of poly his or her fingertips, taking care to tearing of adjacent friable tissue. (vinylidene fluoride) and poly avoid instrument damage to the CHAPTER 2 19

CONTINUOUS SUTURES Also referred to as running stitches, FIGURE 1 continuous sutures are a series of stitches taken with one strand of LIGATURES material. The strand may be tied to itself at each end, or looped, with both cut ends of the strand tied Free tie Stick tie together. A continuous suture line can be placed rapidly. It derives its strength from tension distributed evenly along the full length of the suture strand. However, care must FIGURE be taken to apply firm tension, 2 rather than tight tension, to avoid CONTINUOUS SUTURING INTERRUPTED SUTURING Two strands knotted at TECHNIQUES Looped suture, knotted each end and knotted in TECHNIQUES at one end the middle FIGURE 3

Simple interrupted Over-and-over running Running locked suture stitch suture. Additional throws are added THE PRIMARY SUTURE LINE as needed to square and secure the The primary suture line is the line knot. Stick tie, suture ligature, or of sutures that holds the wound transfixion suture is a strand of edges in approximation during suture material attached to a needle healing by first intention. It may to ligate a vessel, duct, or other consist of a continuous strand of Interrupted vertical mattress structure. This technique is used on material or a series of interrupted deep structures where placement of suture strands. Other types of a hemostat is difficult or on vessels primary sutures, such as deep of large diameter. The needle is sutures, buried sutures, purse-string passed through the structure or sutures, and subcuticular sutures, adjacent tissue first to anchor the are used for specific indications. suture, then tied around the Regardless of technique, a surgical structure. Additional throws are needle is attached to the suture used as needed to secure the knot. strand to permit repeated passes Interrupted horizontal through tissue. mattress

* Trademark ABSORBABLE SUTURES SUTURE TYPES COLOR OF RAW MATERIAL TENSILE STRENGTH ABSORPTION RATE TISSUE REACTION MATERIAL RETENTION in vivo Surgical Gut Plain Yellowish-tan Collagen derived from Individual patirent characteristics can Absorbed by proleolytic Moderate reaction Suture healthy beef and sheep. affect rate of tensile strength loss. enzymatic digestive Blue Dyed process.

Surgical Gut Chromic Brown Collagen derived from Individual patirent characteristics can Absorbed by proleolytic Moderate reaction Suture healthy beef and sheep. affect rate of tensile strength loss. enzymatic digestive Blue Dyed process.

Coated Braided Undyed Copolymer of lactide Approximately 50% remains at 5 Essentially complete Minimal to moderate VICRYL* RAPIDE (Natural) and glycolide coated days. All tensile strength is lost at between 42 days. acute inflammatory (polyglactin 910) with 370 and calcium approximately 14 days. Absorbed by hydrolysis. reaction Suture stearate. Approximately 50-60% (violet: 60-70%) MONOCRYL* Monofilament Undyed Copolymer of Complete at 91-119 Minimal acute (poliglecaprone 25) (Natural) glycolide and remains at 1 week. Approximately 20- days. Absorbed by inflammatory reaction Suture epsilon-caprolactone. 30% (violet: 30-40%) remains at 2 weeks. hydrolysis. Violet Lost within 3 weeks (violet: 4 weeks).

Coated VICRYL* Braided Undyed Copolymer of lactide Approximately 75% remains at two Essentially complete Minimal acute Plus Antibacterial (Natural) and glycolide coated weeks. Approximately 50% remains between 56-70 days. inflammatory reaction (polyglactin 910) Monofilament with 370 and calcium at three weeks, 25% at four weeks. Absorbed by hydrolysis. Suture Violet stearate.

Coated VICRYL* Braided Violet Copolymer of lactide Approximately 75% remains at two Essentially complete Minimal acute (polyglactin 910) and glycolide coated weeks. Approximately 50% remains between 56-70 days. inflammatory reaction Suture Monofilament Undyed with 370 and calcium at three weeks, 25% at four weeks. Absorbed by hydrolysis. (Natural) stearate. PDS* II Monofilament Violet Polyester polymer. Approximately 70% remains at 2 weeks. Minimal until about 90th Slight reaction (polydioxanone) Approximately 50% remains at 4 weeks. day. Essentially complete Blue Suture Approximately 25% remains at 6 weeks. within 6 months. Absorbed Clear by slow hydrolysis.

NONABSORBABLE SUTURES PERMA-HAND* Braided Violet Organic protein called Progressive degradation of fiber may Gradual encapsulation Acute inflammatory Silk Suture fibrin. result in gradual loss of tensile by fibrous connective reaction White strength over time. tissue.

Surgical Stainless Monofilament Silver metallic 316L stainless steel. Indefinate. Nonabsorbable. Minimal acute Steel Suture inflammatory reaction Mulifilament

ETHILON* Monofilament Violet Long-chain aliphatic Progressive hydrolysis may result in Gradual encapsulation Minimal acute Nylon Suture polymers Nylon 6 or gradual loss of tensile strength over Green by fibrous connective inflammatory reaction Nylon 6,6. time. tissue. Undyed (Clear)

NUROLON* Braided Violet Long-chain aliphatic Progressive hydrolysis may result in Gradual encapsulation Minimal acute Nylon Suture polymers Nylon 6 or gradual loss of tensile strength over Green by fibrous connective inflammatory reaction Nylon 6,6. time. tissue. Undyed (Clear) MERSILENE* Braided Green Poly (ethylene No significant change known to Gradual encapsulation Minimal acute Polyester Fiber terephthalate). occur in vivo. by fibrous connective inflammatory reaction Suture Monofilament Undyed (White) tissue.

ETHIBOND* Braided Green Poly (ethylene No significant change known to Gradual encapsulation Minimal acute EXCEL Polyester terephthalate) coated occur in vivo. by fibrous connective inflammatory reaction Fiber Suture Undyed (White) with polybutilate. tissue.

PROLENE* Monofilament Clear Isotactic crystalline No subject to degradation or Nonabsorbable. Minimal acute Polypropylene stereoisomer of weakening by action of tissue inflammatory reaction Suture Blue polypropylene. enzymes.

PRONOVA* Monofilament Blue Polymer blend of poly No subject to degradation or Nonabsorbable. Minimal acute POLY (hexafluoro- (vinylidene fluoride) weakening by action of tissue inflammatory reaction propylene-VDF) and poly (vinylidene enzymes. Suture fluoride-cohexafluoro- propylene). CONTRAINDICATIONS FREQUENT USES HOW SUPPLIED COLOR CODE OF PACKETS TABLE Being absorbable, should not be used General soft tissue approximation 7-0 thru 3 with and without needles, Yellow 5 where extended approximation of tissues and/or ligation, including use in and on LIGAPAK dispensing reels under stress is required. Should not be ophthalmic procedures. Not for use 0 thru 1 with CONTROL SUTURING used in patients with known sensitivities in cardiovascular and neurological RELEASE needles or allergies to collagen or chromium. tissues. OPTIONS: MATERIALS, Being absorbable, should not be used General soft tissue approximation 7-0 thru 3 with and without needles, Beige CHARACTERISTICS, where extended approximation of tissues and/or ligation, including use in and on LIGAPAK dispensing reels under stress is required. Should not be ophthalmic procedures. Not for use 0 thru 1 with CONTROL AND APPLICATIONS used in patients with known sensitivities in cardiovascular and neurological RELEASE needles or allergies to collagen or chromium. tissues. Should not be used where extended Superficial soft tissue approximation 5-0 thru 1 with needles Red approximation of tissue under stress is of skin and mucosa only. Not for use required or where wound support beyond in ligation, ophthalmic, cardiovascu- 7 days is required. lar or neurological procedures.

Being absorbable, should not be used General soft tissue approximation 6-0 thru 2 with and without needles Coral where extended approximation of tissue and/or ligation. Not for use in car- 3-0 thru 1 with CONTROL under stress is required. Undyed not diovascular and neurological tissues, RELEASE needles indicated for use in fascia. microsurgery, or ophthalmic surgery.

Being absorbable, should not be used General soft tissue approximation 5-0 thru 2 with and without needles Violet where extended approximation of tissue and/or ligation. Not for use in cardio- is required. vascular and neurological tissues.

Being absorbable, should not be used General soft tissue approximation 8-0 thru 3 with and without needles, Violet where extended approximation of tissue and/or ligation, including use in and on LIGAPAK dispensing reels ophthalmic procedures. Not for use in 4-0 thru 2 with CONTROL RELEASE is required. needles; 8-0 with attached beads for cardiovascular and neurological tissues. ophthalmic use Being absorbable, should not be used where All types of soft tissue approxima- 9-0 thru 2 with needles Silver prolonged approximation of tissues under tion, including pediatric cardiovascu- 4-0 thru 2 with CONTROL stress is required. Should not be used with lar and ophthalmic procedures. Not RELEASE needles prosthetic devices, such as heart valves or for use in adult cardiovascular tissue, 9-0 thru 7-0 with needles synthetic grafts. microsurgery, and neural tissue. 7-0 thru 1 with needles

Should not be used in patients with General soft tissue approximation 9-0 thru 5 with and without needles, Light Blue known sensitivities or allergies to silk. and/or ligation, including and on LIGAPAK dispensing reels cardiovascular, ophthalmic and 4-0 thru 1 with CONTROL neurological procedures. RELEASE needles Should not be used in patients with Abdominal wound closure, hernia 10-0 thru 7 with and without needles Yellow-Ochre known sensitivities or allergies to 316L repair, sternal closure and orthoaedic stainless steel, or constituent metals such procedures including cerclage and as chromium and nickel. tendon repair. Should not be used where permanent General soft tissue approximation 11-0 thru 2 with and without needles Mint Green retention of tensile strength is required. and/or ligation, including cardiovascular, ophthalmic and neurological procedures. Should not be used where permanent General soft tissue approximation 6-0 thru 1 with and without needles Mint Green retention of tensile strength is required. and/or ligation, including 4-0 thru 1 with CONTROL cardiovascular, ophthalmic and RELEASE needles neurological procedures. None known. General soft tissue approximation 6-0 thru 5 with and without needles Turquoise and/or ligation, including 10-0 and 11-0 for ophthalmic (green cardiovascular, ophthalmic and monofilament); 0 with CONTROL neurological procedures. RELEASE needles None known. General soft tissue approximation 7-0 thru 5 with and without needles Orange and/or ligation, including 4-0 thru 1 with CONTROL cardiovascular, ophthalmic and RELEASE needles; various sizes neurological procedures. attached to TFE polymer pledgets

None known. General soft tissue approximation 6-0 thru 2 (clear) with and without Deep Blue and/or ligation, including needles; 10-0 thru 8-0 and 6-0 thru 2 with and without needles; 0 thru 2 with cardiovascular, ophthalmic and CONTROL RELEASE needles; various neurological procedures. sizes attached to TFE polymer pledgets None known. General soft tissue approximation 6-0 through 5-0 with TAPERCUT* Royal Blue and/or ligation, including surgical needle cardiovascular, ophthalmic and 8-0 through 5-0 with taper point neurological procedures. needle * Trademark 22 THE SUTURE

tissue strangulation. Excessive tension and instrument damage should be avoided to prevent suture FIGURE breakage which could disrupt the 4 entire line of a continuous suture. DEEP Continuous suturing leaves less SUTURES foreign body mass in the wound. In the presence of infection, it may be desirable to use a monofilament suture material because it has no interstices which can harbor microorganisms. This is especially critical as a continuous suture line can transmit infection along the entire length of the strand. A continuous one layer mass closure may be used on peritoneum and/or fascial layers of the abdominal wall to provide a temporary seal during FIGURE 5 the healing process. PURSE-STRING INTERRUPTED SUTURES SUTURES Interrupted sutures use a number of strands to close the wound. Each strand is tied and cut after insertion. This provides a more secure closure, because if one suture breaks, the remaining sutures will hold the wound edges in approximation. Interrupted sutures may be used if a wound is infected, because microorganisms may be less likely to travel along a series of nique is useful when using large organ prior to insertion of a tube interrupted stitches. diameter permanent sutures on (such as the aorta, to hold the deeper layers in thin patients who cannulation tube in place during DEEP SUTURES may be able to feel large knots that an open heart procedure). Deep sutures are placed completely are not buried. under the epidermal skin layer. SUBCUTICULAR SUTURES They may be placed as continuous PURSE-STRING SUTURES Subcuticular sutures are continuous or interrupted sutures and are not Purse-string sutures are continuous or interrupted sutures placed in the removed postoperatively. sutures placed around a lumen and dermis, beneath the epithelial layer. tightened like a drawstring to Continuous subcuticular sutures are BURIED SUTURES invert the opening. They may be placed in a line parallel to the Buried sutures are placed so that the placed around the stump of the wound. This technique involves knot protrudes to the inside, under appendix, in the bowel to secure an taking short, lateral stitches the full the layer to be closed. This tech- intestinal stapling device, or in an length of the wound. After the CHAPTER 2 23

• To support wounds for healing by second intention. FIGURE • For secondary closure following 6 wound disruption when healing SUBCUTANEOUS by third intention. SUTURES NOTE: If secondary sutures are used in cases of nonhealing, they should be placed in opposite fashion from the primary sutures (i.e., interrupted if the primary sutures were continuous, continuous if the primary sutures were interrupted). Retention sutures are placed approxi- mately 2 inches from each edge of the wound. The tension exerted lateral to the primary suture line contributes to the tensile strength of FIGURE 7 the wound. Through-and-through sutures are placed from inside the RETENTION peritoneal cavity through all layers SUTURE of the abdominal wall, including the BOLSTER peritoneum. They should be insert- ed before the peritoneum is closed using a simple interrupted stitch. The wound may be closed in layers for a distance of approximately three-fourths its length. Then the retention sutures in this area may be drawn together and tied. It is important that a finger be placed within the abdominal cavity to prevent strangulation of the viscera suture has been drawn taut, the THE SECONDARY in the closure. The remainder of the distal end is anchored in the same SUTURE LINE wound may then be closed. Prior manner as the proximal end. This A secondary line of sutures may to tightening and tying the final may involve tying or any of a be used: retention sutures, it is important variety of anchoring devices. • To reinforce and support the to explore the abdomen again with Subcuticular suturing may be primary suture line, eliminate a finger to prevent strangulation performed with absorbable suture dead space, and prevent fluid of viscera in the closure. The which does not require removal, or accumulation in an abdominal remainder of the wound may then with monofilament nonabsorbable wound during healing by first be closed. suture that is later removed by intention. When used for this simply removing the anchoring purpose, they may also be called Retention sutures utilize device at one end and pulling the retention, stay, or tension sutures. nonabsorbable suture material. opposite end. They should therefore be removed as soon as the danger of sudden

* Trademark 24 THE SUTURE

increases in intra-abdominal The stretching characteristics Suture knots must be properly pressure is over— usually 2 to 6 provide the signal that alerts the placed to be secure. Speed in knot weeks, with an average of 3 weeks. surgeon to the precise moment tying frequently results in less than when the suture knot is snug. perfect placement of the strands. STITCH PLACEMENT In addition to variables inherent in The type of knot tied will depend Many types of stitches are used the suture materials, considerable upon the material used, the depth for both continuous and interrupted variation can be found between and location of the incision, and the suturing. In every case, equal knots tied by different surgeons amount of stress that will be placed "bites" of tissue should be taken and even between knots tied by upon the wound postoperatively. on each side of the wound. The the same individual on different Multifilament sutures are generally needle should be inserted from occasions. easier to handle and tie than 1 to 3 centimeters from the edge monofilament sutures, however, all The general principles of knot of the wound, depending upon the the synthetic materials require a tying which apply to all suture type and condition of the tissue specific knotting technique. With materials are: being sutured. multifilament sutures, the nature of 1. The completed knot must be the material and the braided or firm, and so tied that slipping is KNOT TYING twisted construction provide a high virtually impossible. The coefficient of friction and the knots Of the more than 1,400 different simplest knot for the material is remain as they are laid down. In types of knots described in THE the most desirable. monofilament sutures, on the other ENCYLCOPEDIA OF KNOTS, hand, the coefficient of friction is 2. The knot must be as small as only a few are used in modern relatively low, resulting in a greater possible to prevent an excessive surgery. It is of paramount tendency for the knot to loosen amount of tissue reaction when importance that each knot placed after it has been tied. In addition, absorbable sutures are used, or to for approximation of tissues or monofilament synthetic polymeric minimize foreign body reaction ligation of vessels be tied with materials possess the property of to nonabsorbable sutures. Ends precision and each must hold with memory. Memory is the tendency should be cut as short as possible. proper tension. not to lie flat, but to return to a 3. In tying any knot, friction given shape set by the material’s KNOT SECURITY between strands ("sawing") must extrusion process or the suture’s The construction of ETHICON* be avoided as this can weaken the packaging. The RELAY* suture sutures has been carefully integrity of the suture. delivery system delivers sutures with designed to produce the optimum minimal package memory due to its combination of strength, unique package design. uniformity, and hand for each material. The term hand is the most subtle of all suture quality CONTINUOUS SUTURE INTERRUPTED SUTURES aspects. It relates to the feel of the To appose skin and other tissue TABLE suture in the surgeon’s hands, the Over-and-over Over-and-over 6 smoothness with which it passes Subcuticular Vertical mattress through tissue and ties down, the Horizontal mattress COMMONLY USED TYPES way in which knots can be set and To invert tissue snugged down, and most of all, to OF STITCHES Lembert Lembert the firmness or body of the suture. Cushing Halsted Extensibility relates to the way in Connell Purse-string which the suture will stretch slightly To evert tissue during knot tying and then recover. Horizontal mattress Horizontal mattress CHAPTER 2 25

4. Care should be taken to avoid KNOT TYING TECHNIQUES damage to the suture material MOST OFTEN USED FIGURE 8 when handling. Avoid the An important part of good suturing crushing or crimping application technique is correct method in FINISHED of surgical instruments, such as knot tying. A seesaw motion, or SUTURE needleholders and forceps, to the the sawing of one strand down over TIES strand except when grasping the another until the knot is formed, Square knot free end of the suture during an may materially weaken sutures to instrument tie. the point that they may break when the second throw is made, or even 5. Excessive tension applied by the worse, in the postoperative period surgeon will cause breaking of when the suture is further weakened the suture and may cut tissue. by increased tension or motion. If Practice in avoiding excessive the two ends of the suture are tension leads to successful use of pulled in opposite directions with finer gauge materials. uniform rate and tension, the knot Surgeon’s knot–first 6. Sutures used for approximation may be tied more securely. throw should not be tied too tightly, Some procedures involve tying because this may contribute to knots with the fingers, using one or tissue strangulation. two hands; others involve tying with 7. After the first loop is tied, it is the help of instruments. Perhaps necessary to maintain traction the most complex method of knot on one end of the strand to tying is done during endoscopic avoid loosening of the throw if procedures, when the surgeon must being tied under any tension. manipulate instruments from well Surgeon’s knot–second outside the body cavity. throw 8. Final tension on final throw should be as nearly horizontal Following are the most frequently as possible. used knot tying techniques with accompanying illustrations of 9. The surgeon should not hesitate finished knots. to change stance or position in relation to the patient in order SQUARE KNOT to place a knot securely and flat. The two-hand square knot is the 10. Extra ties do not add to the easiest and most reliable for tying strength of a properly tied and most suture materials. It may be Deep tie squared knot. They only used to tie surgical gut, virgin silk, contribute to its bulk. With surgical cotton, and surgical stain- some synthetic materials, knot less steel. Standard technique of flat security requires the standard and square ties with additional surgical technique to flat and throws if indicated by the surgical square ties with additional circumstance and the experience of throws if indicated by surgical the operator should be used to tie circumstance and the experience MONOCRYL* (poliglecaprone 25) of the surgeon. suture, VICRYL* suture, Coated VICRYL* suture, Coated VICRYL* Instrument tie RAPIDE (polyglactin 910) suture,

* Trademark 26 THE SUTURE

PDS* II (polydioxanone) suture, LIGATION USING A is cut from the suture and removed. ETHILON* nylon suture, HEMOSTATIC CLAMP Several loops are made with the ETHIBOND* EXCEL polyester Frequently it is necessary to ligate suture around the needleholder, suture, PERMA-HAND* silk a blood vessel or tissue grasped in and the end of the suture is pulled suture, PRONOVA* poly (hexafluo- a hemostatic clamp to achieve through the loops. This technique ropropylene-VDF) suture, and hemostasis in the operative field. is then repeated to form a surgeon's PROLENE* polypropylene suture. knot, which is tightened by the INSTRUMENT TIE knot pusher. Wherever possible, the square The instrument tie is useful when knot is tied using the two-hand In both extracorporeal and intracor- one or both ends of the suture technique. On some occasions it poreal knot tying, the following material are short. For best results, will be necessary to use one hand, principles of suture manipulation exercise caution when using a either the left or the right, to tie a on tissue should be observed: needleholder with any monofila- square knot. ment suture, as repeated bending 1. Handle tissue as gently as CAUTION: If the strands of a may cause these sutures to break. possible to avoid tissue trauma. square knot are inadvertently incorrectly crossed, a granny knot ENDOSCOPIC KNOT 2. Grasp as little tissue as possible. will result. Granny knots are not TYING TECHNIQUES 3. Use the smallest suture possible recommended because they have a During an endoscopic procedure, for the task. tendency to slip when subjected to a square knot or surgeon's knot may 4. Exercise care in approximating increased stress. be tied either outside the abdomen the knot so that the tissue being and pushed down into the body approximated is not strangulated. SURGEON’S OR through a trocar (extracorporeal) 5. Suture must be handled with care FRICTION KNOT or directly within the abdominal to avoid damage. The surgeon's or friction knot is cavity (intracorporeal). recommended for tying VICRYL* In extracorporeal knot tying, the CUTTING THE suture, Coated VICRYL* suture, suture appropriately penetrates the SECURED SUTURES ETHIBOND* EXCEL polyester tissue, and both needle and suture Once the knot has been securely suture, ETHILON* nylon suture, are removed from the body cavity, tied, the ends must be cut. Before MERSILENE* polyester fiber bringing both suture ends outside cutting, make sure both tips of suture, NUROLON* nylon suture, of the trocar. Then a series of the scissors are visible to avoid PRONOVA* poly (hexafluoro- half-hitches are tied, each one inadvertently cutting tissue beyond propylene-VDF) suture, and being pushed down into the cavity the suture. PROLENE* polypropylene and tightened with an endoscopic suture. The surgeon’s knot also knot pusher. Cutting sutures entails running may be performed using a the tip of the scissors lightly down one-hand technique. Intracorporeal knot tying is the suture strand to the knot. performed totally within the The ends of surgical gut are left DEEP TIE abdominal cavity. After the suture relatively long, approximately Tying deep in a body cavity can be has penetrated the tissue, the needle 1/4" (6mm) from the knot. difficult. The square knot must be firmly snugged down as in all SUTURE LOCATION TIME FOR SUTURE REMOVAL TABLE situations. However, the operator 7 must avoid upward tension which Skin on the face and neck 2 to 5 days may tear or avulse the tissue. SUTURE Other skin sutures 5 to 8 days REMOVAL Retention sutures 2 to 6 weeks CHAPTER 2 27

Other materials are cut closer to the be removed easily without cutting. 7. Don't store surgical gut knot, approximately 1/8" (3mm), A common practice is to cover the near heat. to decrease tissue reaction and skin sutures with PROXI-STRIP* 8. Moisten—but never soak— minimize the amount of foreign skin closures during the required surgical gut. material left in the wound. To healing period. After the wound ensure that the actual knot is not edges have regained sufficient tensile 9. Do not wet rapidly absorbing cut, twist or angle the blades of the strength, the sutures may be sutures. scissors prior to cutting. removed by simply removing the 10. Keep silk dry. Make certain to remove the PROXI-STRIP skin closures. cut ends of the suture from the 11. Wet linen and cotton to increase operative site. their strength. SUTURE HANDLING TIPS 12. Don't bend stainless steel wire. SUTURE REMOVAL These guidelines will help the surgical 13. Draw nylon between gloved When the external wound has team keep their suture inventory up fingers to remove the packaging healed so that it no longer needs the to date and their sutures in the best "memory." support of nonabsorbable suture possible condition. 14. Arm a needleholder properly. material, skin sutures must be 1. Read labels. removed. The length of time the sutures remain in place depends 2. Heed expiration dates and SUTURE SELECTION upon the rate of healing and the rotate stock. PROCEDURE nature of the wound. General rules 3. Open only those sutures needed PRINCIPLES OF are as follows. for the procedure at hand. SUTURE SELECTION Sutures should be removed using 4. Straighten sutures with a gentle The surgeon has a choice of suture aseptic and sterile technique. The pull. Never crush or rub them. materials from which to select for surgeon uses a sterile suture removal use in body tissues. Adequate tray prepared for the procedure. 5. Don't pull on needles. strength of the suture material will The following steps are taken: 6. Avoid crushing or crimping prevent suture breakage. Secure • STEP 1—Cleanse the area with suture strands with surgical knots will prevent knot slippage. an antiseptic. Hydrogen peroxide instruments. But the surgeon must understand can be used to remove dried serum the nature of the suture material, encrusted around the sutures. • STEP 2—Pick up one end of the suture with thumb forceps, and cut as close to the skin as possible FIGURE where the suture enters the skin. 9 • STEP 3—Gently pull the suture ARMING strand out through the side oppo- A NEEDLE- site the knot with the forceps. To HOLDER prevent risk of infection, the suture PROPERLY should be removed without pulling any portion that has been outside the skin back through the skin. NOTE: Fast absorbing synthetic or gut suture material tend to lose all tensile strength in 5 to 7 days and can Grasp the needle one-third to one-half of the distance from the swaged end to the point. * Trademark 28 THE SUTURE

the biologic forces in the healing Therefore: closure. Wounds of the stomach and wound, and the interaction of a. In the urinary and biliary intestine are rich in blood supply the suture and the tissues. The tracts, use rapidly absorbed and may become edematous and following principles should guide sutures. hardened. Tight sutures may cut the surgeon in suture selection. 5. Regarding suture size: through the tissue and cause 1. When a wound has reached a. Use the finest size suture leakage. A leak-proof anastomosis maximal strength, sutures are no commensurate with the can be achieved with either a longer needed. Therefore: natural strength of the tissue. single or double-layer closure. b. If the postoperative course of a. Tissues that ordinarily heal For a single-layer closure, interrupt- the patient may produce slowly such as skin, fascia, ed sutures should be placed sudden strains on the suture and tendons should usually approximately 1/4" (6mm) apart. line, reinforce it with be closed with nonabsorbable Suture is placed through the retention sutures. Remove sutures. An absorbable suture submucosa, into the muscularis and them as soon as the patient’s with extended (up to 6 through the serosa. Because the condition is stabilized. months) wound support may submucosa provides strength in also be used. SURGERY WITHIN THE the gastrointestinal tract, effective b. Tissues that heal rapidly ABDOMINAL WALL CAVITY closure involves suturing the such as stomach, colon and submucosal layers in apposition Entering the abdomen, the surgeon bladder may be closed with without penetrating the mucosa. will need to seal or tie off absorbable sutures A continuous suture line provides a subcutaneous blood vessels 2. Foreign bodies in potentially tighter seal than interrupted sutures. immediately after the incision is contaminated tissues may convert However, if a continuous suture made, using either an electrosurgical contamination into infection. breaks, the entire line may separate. 3. Where cosmetic results are unit designed for this purpose or important, close and prolonged free ties (ligatures). If ligatures are Many surgeons prefer to use a apposition of wounds and used, an absorbable suture material double-layer closure, placing a avoidance of irritants will is generally preferred. When second layer of interrupted sutures produce the best results. preparing the ties, the scrub person through the serosa for insurance. Therefore: often prepares one strand on a Absorbable VICRYL* sutures, or a. Use the smallest inert needle for use as a suture ligature chromic gut sutures may be used monofilament suture should the surgeon wish to in either a single or double-layer materials such as nylon transfix a large blood vessel. closure. Surgical silk may also be or polypropylene. Once inside, the type of suture used for the second layer of a b. Avoid skin sutures and close double-layer closure. subcuticularly whenever selected will depend upon the Inverted, everted, or end-to-end possible. nature of the operation and the closure techniques have all been c. Under certain circumstances, surgeon's technique. used successfully in this area, but to secure close apposition of they all have drawbacks. The THE GASTROINTESTINAL TRACT skin edges, a topical skin surgeon must take meticulous care adhesive or skin closure Leakage from an anastomosis in placing the sutures in the submu- tape may be used. or suture site is the principal cosa. Even with the best technique, 4. Foreign bodies in the presence problem encountered performing some leakage may occur. of fluids containing high concen- a procedure involving the Fortunately, the omentum usually trations of crystalloids may act gastrointestinal tract. This problem confines the area, and natural body as a nidus for precipitation and can lead to localized or generalized defenses handle the problem. stone formation. peritonitis. Sutures should not be tied too tightly in an anastomotic CHAPTER 2 29

layer for added assurance. The small intestine heals very FIGURE 10 rapidly, reaching maximal strength in approximately 14 days.

Single layer Double layer ANASTOMOTIC CLOSURE THE COLON TECHNIQUE The high microbial content of the colon once made contamination a major concern. But absorbable sutures, once absorbed, leave no channel for microbial migration. Still, leakage of large bowel contents is of great concern as it is potentially more serious than FIGURE 11 leakage in other areas of the gastrointestinal tract. INVERTED The colon is a strong organ— CLOSURE TECHNIQUE approximately twice as strong in the sigmoid region as in the cecum. Yet, wounds of the colon gain strength at the same rate regardless of their location. This permits the same suture size to be used at either end of the colon. The colon heals at a rate similar to that of the stomach and small intestine. A high rate of collagen synthesis is maintained for THE STOMACH THE SMALL INTESTINE a prolonged period (over 120 days). For an organ that contains free Closure of the small intestine The entire gastrointestinal tract hydrochloric acid and potent presents the same considerations exhibits a loss of collagen and proteolytic enzymes, the stomach as the stomach. Proximal intestinal increased collagenous activity heals surprisingly quickly. contents, primarily bile or immediately following colon Stomach wounds attain maximum pancreatic juices, may cause a anastomosis. Both absorbable and strength within 14 to 21 days severe chemical (rather than nonabsorbable sutures may be used bacterial) peritonitis. for closure of the colon. Placement postoperatively, and have a peak If using an inverted closure of sutures in the submucosa, rate of collagen synthesis at 5 days. technique, care must be taken to avoiding penetration of the mucosa, minimize the cuff of tissue which will help prevent complications. Absorbable sutures are usually protrudes into the small sized acceptable in the stomach, although intestinal lumen in order to avoid THE RECTUM they may produce a moderate partial or complete obstruction. The rectum heals very slowly. reaction in both the wound and Absorbable sutures are usually Because the lower portion is below normal tissue. Coated VICRYL* preferred, particularly because they the pelvic peritoneum, it has no sutures are most commonly used. will not permanently limit the serosa. A large bite of muscle should PROLENE* sutures may also be lumen diameter. A nonabsorbable be included in an anastomosis, and used for stomach closure. suture may be used in the serosal the sutures should be tied carefully to avoid cutting through the tissues. * Trademark 30 THE SUTURE

Monofilament sutures reduce the risk of bacterial proliferation in FIGURE the rectum. 12

THE BILIARY TRACT LIVER THE GALLBLADDER RESECTION Within the gallbladder, the cystic and common bile ducts heal rapidly. Their contents present special considerations for suture selection. The presence of a foreign body such as a suture in an organ that is prone to crystal formation may precipitate the formation of "stones." Multifilament sutures should probably not be used because it

is not always possible to prevent Skin exposure of a suture in the ducts. Subcutaneous fat FIGURE The surgeon should choose an 13 absorbable suture in the finest size possible that leaves the least surface THE area exposed. ABDOMINAL WALL PARENCHYMATOUS ORGANS THE SPLEEN, LIVER AND KIDNEY On occasion, a surgeon may be Muscle tissue called upon to repair a laceration Peritoneum Transversalis fascia of one of these vital organs. If large vessels, particularly arteries, provide closure. Sutures do not need CLOSING THE ABDOMEN within these organs have been to be placed close together or deeply When closing the abdomen, the severed, they must be located into the organ. closure technique may be more and ligated before attempting important than the type of suture to close the defect. Otherwise, Lacerations in this area tend to material used. hematomas or secondary hemor- heal rapidly. New fibrous tissue will rhage may occur. usually form over the wound with THE PERITONEUM 7 to 10 days. Because these organs are composed The peritoneum, the thin membra- chiefly of cells with little connective In a liver resection, suturing of the nous lining of the abdominal cavity, tissue for support, attempts must wedges in a horizontal through- lies beneath the posterior fascia. It be made to coapt the outer fibrous and-through fashion should hold heals quickly. Some believe that the capsule of the torn tissue. In the the tissue securely. Large vessels peritoneum does not require sutur- absence of hemorrhage, little tension should be tied using VICRYL* ing, while others disagree. If the is placed on the suture line and only sutures or silk. Raw surfaces can be posterior fascia is securely closed, small size sutures need to be used. If closed or repaired using VICRYL suturing the peritoneum may not the tissue cannot be approximated, (polyglactin 910) mesh. contribute to the prevention of an tacking a piece of omentum over incisional hernia. Among surgeons the defect will usually suffice to who choose to close the peri- toneum, a continuous suture line CHAPTER 2 31 with absorbable suture material is always closed. The anterior layer monofilament absorbable material is usually preferred. Interrupted may be cut and may also require like PDS II sutures or inert nonab- sutures can also be used for suturing. Mass closure techniques sorbable sutures like stainless steel or this procedure. are becoming the most popular. PROLENE* sutures may be used.

FASCIA Most suture materials have some MUSCLE This layer of firm, strong connective inherent degree of elasticity. If not Muscle does not tolerate suturing tissue covering the muscles is the tied too tightly, the suture will well. However, there are several main supportive structure of the "give" to accommodate postopera- options in this area. body. In closing an abdominal tive swelling that occurs. Stainless Abdominal muscles may be either incision, the fascial sutures must steel sutures, if tied too tightly, will cut, split (separated), or retracted, hold the wound closed and cut like a knife as the tissue swells depending upon the location and also help to resist changes in intra- or as tension is placed upon the type of the incision chosen. Where abdominal pressure. Occasionally, suture line. Because of the slow possible, the surgeon prefers to synthetic graft material may be healing time and because the fascial avoid interfering with the blood used when fascia is absent or weak. suture must bear the maximum supply and nerve function by PROLENE* polypropylene mesh may stress of the wound, a moderate size making a muscle-splitting incision be used to replace abdominal wall nonabsorbable suture may be used. or retracting the entire muscle or repair hernias when a great deal An absorbable suture with longer toward its nerve supply. During of stress will be placed on the suture lasting tensile strength, such as closure, muscles handled in this line during healing. Nonabsorbable PDS* II sutures, may also provide manner do not need to be sutured. sutures such as PROLENE suture adequate support. PDS II sutures The fascia is sutured rather than may be used to suture the graft to are especially well-suited for use in the muscle. the tissue. younger, healthy patients. The Smead-Jones far-and-near- Fascia regains approximately 40% Many surgeons prefer the use of technique for abdominal wound of its original strength in 2 months. interrupted simple or figure-of eight closure is strong and rapid, provides It may take up to a year or longer to sutures to close fascia, while others good support during early healing regain maximum strength. Full employ running suture or a with a low incidence of wound original strength is never regained. combination of these techniques. In the absence of infection or gross disruption, and has a low incidence The anatomic location and type of contamination, the surgeon may of late incisional problems. This is abdominal incision will influence choose either monofilament or a single-layer closure through both how may layers of fascia will be multifilament sutures. In the layers of the abdominal wall fascia, sutured. The posterior fascial layer presence of infection, a abdominal muscles, peritoneum,

FIGURE 14

SURGICAL OPTIONS IN MUSCLE

Cutting Splitting Retracting

* Trademark 32 THE SUTURE

and the anterior fascial layer. size of material used earlier to ligate of maintaining sufficient tensile The interrupted sutures resemble a blood vessels in this layer. strength through the collagen "figure of eight" when placed. synthesis stage of healing which Absorbable PDS II sutures or SUBCUTICULAR TISSUE lasts approximately 6 weeks. The VICRYL* sutures are usually used. To minimize scarring, suturing sutures must not be placed too the subcuticular layer of tough close to the epidermal surface to Stainless steel sutures may also be connective tissue will hold the skin reduce extrusion. If the skin is used. Monofilament PROLENE edges in close approximation. In a nonpigmented and thin, a clear or sutures also provide all the single-layer subcuticular closure, less white monofilament suture such advantages of steel sutures: strength, evidence of scar gaping or expansion as MONOCRYL suture will be minimal tissue reactivity, and may be seen after a period of 6 to 9 invisible to the eye. MONOCRYL resistance to bacterial contamination. months than is evident with simple suture is particularly well-suited for They are better tolerated than steel skin closure. The surgeon takes this closure because, as a monofila- sutures by patients in the late continuous short lateral stitches ment, it does not harbor infection postoperative months and are easier beneath the epithelial layer of skin. and, as a synthetic absorbable for the surgeon to handle and tie. Either absorbable or nonabsorbable suture, tissue reaction is minimized. However, both stainless steel and sutures may be used. If nonab- After this layer is closed, the skin PROLENE sutures may be sorbable material is chosen, one end edges may then be approximated. detectable under the skin of thin of the suture strand will protrude patients. To avoid this problem, from each end of the incision, and SKIN knots should be buried in fascia the surgeon may tie them together Skin is composed of the epithelium instead of in the subcutaneous space. to form a "loop" or knot the ends and the underlying dermis. It is so outside of the incision. tough that a very sharp needle is SUBCUTANEOUS FAT essential for every stitch to minimize Neither fat nor muscle tolerate To produce only a hair-line scar tissue trauma. (See Chapter 3: The suturing well. Some surgeons (on the face, for example), the Surgical Needle.) question the advisability of placing skin can be held in very close sutures in fatty tissue because it approximation with skin closure Skin wounds regain tensile strength has little tensile strength due to tapes in addition to subcuticular slowly. If a nonabsorbable suture its composition, which is mostly sutures. Tapes may be left on the material is used, it is typically water. However, others believe it wound for an extended period of removed between 3 and 10 days is necessary to place at least a time depending upon their location postoperatively, when the wound few sutures in a thick layer of on the body. has only regained approximately subcutaneous fat to prevent dead 5% to 10% of its strength. This is When great tension is not placed space, especially in obese patients. possible because most of the stress upon the wound, as in facial or Dead spaces are most likely to placed upon the healing wound is neck surgery, very fine sizes of occur in this type of tissue, so absorbed by the fascia, which the subcuticular sutures may be used. the edges of the wound must be surgeon relies upon to hold the Abdominal wounds that must carefully approximated. Tissue wound closed. The skin or withstand more stress call for larger fluids can accumulate in these subcuticular sutures need only be suture sizes. pocket-like spaces, delaying healing strong enough to withstand natural and predisposing infection. Some surgeons choose to close skin tension and hold the wound Absorbable sutures are usually both the subcuticular and epidermal edges in apposition. selected for the subcutaneous layer. layers to achieve minimal scarring. The use of coated VICRYL* VICRYL* suture is especially suited Chromic surgical gut and polymeric RAPIDE suture, a rapidly absorbed for use in fatty, avascular tissue since materials, such as MONOCRYL* synthetic suture, eliminates the it is absorbed by hydrolysis. The suture, are acceptable for placement need for suture removal. Coated surgeon may use the same type and within the dermis. They are capable CHAPTER 2 33

VICRYL RAPIDE suture, which a lower tissue reaction than chromic relatively rare if the skin sutures are is indicated for superficial closure gut suture due to its accelerated not placed with excessive tension of skin and mucosa, provides absorption profile.) The key to and are removed by the seventh short-term wound support success is early suture removal postoperative day. consistent with the rapid healing before epithelialization of the suture The forces that create the distance characteristics of skin. The sutures tract occurs and before contamina- between the edges of the wound begin to fall off in 7 to 10 days, tion is converted into infection. will remain long after the sutures with absorption essentially have been removed. Significant complete at 42 days. A WORD ABOUT SCARRING (EPITHELIALIZATION) collagen synthesis will occur from Suturing technique for skin When a wound is sustained in 5 to 42 days postoperatively. After closure may be either continuous the skin—whether accidentally or this time, any additional gain in or interrupted. Skin edges should during a surgical procedure—the tensile will be due to remodeling, be everted. Preferably, each suture epithelial cells in the basal layer at or crosslinking, of collagen fibers strand is passed through the skin the margins of the wound flatten rather than to collagen synthesis. only once, reducing the chance and move into the wound area. Increases in tensile strength will of cross-contamination across the They move down the wound edge continue for as long as 2 years, but entire suture line. Interrupted until they find living, undamaged the tissue will never quite regain its technique is usually preferred. tissue at the base of the wound. original strength. Then they move across the wound If surgeon preference indicates CLOSURE WITH bed to make contact with similar the use of a nonabsorbable suture RETENTION SUTURES cells migrating from the opposite material, several issues must be We have already discussed the side of the wound. They move considered. Skin sutures are exposed techniques involved with placing down the suture tract after if has to the external environment, retention sutures, and using them been embedded in the skin. When making them a serious threat in a secondary suture line. (See the the suture is removed, the tract of to wound contamination and section on Suturing Techniques.) the epithelial cells remains. stitch abscess. The interstices of Heavy sizes (0 to 5) of nonabsorbable Eventually, it may disappear, but multifilament sutures may provide materials are usually used for some may remain and form keratin. a haven for microorganisms. retention sutures, not for strength, A punctate scar is usually seen on Therefore, monofilament nonab- but because larger sizes are less likely the skin surface and a "railroad sorbable sutures may be preferred for to cut through tissue when a sudden track" or "crosshatch" appearance skin closure. Monofilament sutures rise in intra-abdominal pressure on the wound may result. This is also induce significantly less tissue occurs from vomiting, coughing, reaction than multifilament sutures. For cosmetic reasons, nylon or polypropylene monofilament sutures may be preferred. Many skin FIGURE wounds are successfully closed with 15 silk and polyester multifilaments as well. Tissue reaction to nonab- THE RAILROAD sorbable sutures subsides and TRACK SCAR CONFIGURATION remains relatively acellular as fibrous tissue matures and forms a dense capsule around the suture. (Note, surgical gut has been known to produce tissue reaction. Coated VICRYL* RAPIDE suture elicits

* Trademark 34 THE SUTURE

straining, or distention. To prevent Retention sutures may be left in A drainage tube inserted into the the heavy suture material from place for 14 to 24 days postopera- peritoneal cavity through a stab cutting into the skin under stress, tively. Three weeks is an average wound in the abdominal wall one end of the retention suture may length of time. Assessment of the usually is anchored to the skin with be threaded through a short length patient's condition is the controlling one or two nonabsorbable sutures. of plastic or rubber tubing called a factor in deciding when to remove This prevents the drain from bolster or bumper before it is tied. A retention sutures. slipping into or out of the wound. plastic bridge with adjustable features may also be used to protect SUTURE FOR DRAINS SUTURE NEEDS IN OTHER the skin and primary suture line If a drainage tube is placed in a BODY TISSUES NEUROSURGERY and permit postoperative wound hollow organ or a bladder drain is Surgeons have traditionally used an management for patient comfort. inserted, it may be secured to the interrupted technique to close the wall of the organ being drained galea and dura mater. Properly placed retention sutures with absorbable sutures. The surgeon The tissue of the galea, similar to provide strong reinforcement for may also choose to minimize the abdominal wounds, but also cause the fascia of the abdominal cavity, distance between the organ and the is very vascular and hemostatic. the patient more postoperative pain abdominal wall by using sutures to than does a layered closure. The Therefore, scalp hematoma is a tack the organ being drained to the potential problem, and the surgeon best technique is to use a material peritoneum and fascia. with needles swaged on each end must be certain to close well. Sutures may be placed around the The dura mater is the outermost of (double-armed). They should be circumference of the drain, either placed from the inside of the wound the three meninges that protects the two sutures at 12 and 6 o'clock brain and spinal cord. It tears with toward the outside skin to avoid positions, or four sutures at 12, 3, pulling potentially contaminated ease and cannot withstand too 6, and 9 o'clock positions, and much tension. The surgeon may epithelial cells through the entire secured to the skin with temporary abdominal wall. drain some of the cerebrospinal loops. When the drain is no longer fluid to decrease volume, easing the The ETHICON retention needed, the skin sutures may be tension on the dura before closing. suture line includes ETHILON* easily removed to remove the drain. If it is too damaged to close, a sutures, MERSILENE* sutures, The opening can be left open to patch must be inserted and sutured ETHIBOND* EXCEL sutures, and permit additional drainage until it in place. PERMA-HAND* sutures. Surgical closes naturally. steel sutures may also be used. Surgical silk is appropriate in this area for its pliability and easy knot tying properties. Unfortunately, it elicits a significant foreign body FIGURE tissue reaction. Most surgeons have 16 switched to NUROLON* sutures or coated VICRYL* sutures because PLACEMENT they tie easily, offer greater strength OF SUTURES than surgical silk, and cause less AROUND A DRAIN tissue reaction. PROLENE* sutures have also been accepted by surgeons who prefer a continuous closure technique, who must repair potentially infected wounds, or who must repair dural tears. CHAPTER 2 35

In peripheral nerve repair, precise OPHTHALMIC SURGERY surgical gut and behave dependably, suturing often requires the aid of The eye presents special healing VICRYL sutures have proven useful an operating microscope. Suture challenges. The ocular muscles, the in muscle and cataract surgery. gauge and needle fineness must be conjunctiva, and the sclera have good While some ophthalmic surgeons consistent with nerve size. After blood supplies; but the cornea is an promote the use of a "no-stitch" the motor and sensory fibers are avascular structure. While epithelial- surgical technique, 10-0 coated properly realigned, the epineurium ization of the cornea occurs rapidly VICRYL (polyglactin 910) violet (the outer sheath of the nerve) is in the absence of infection, full monofilament sutures offer distinct sutured. The strength of sutures in thickness cornea wounds heal slowly. advantages. They provide the securi- this area is less of a consideration Therefore, in closing wounds such as ty of suturing immediately follow- than the degree of inflammatory cataract incisions, sutures should ing surgery but eliminate the risks and fibroplastic tissue reaction. remain in place for approximately of suture removal and related Fine sizes of nylon, polyester, and 21 days. Muscle recession, which endophthalmitis. poly-propylene are preferred. involves suturing muscle to sclera, only requires sutures for The ophthalmologist has many MICROSURGERY approximately 7 days. fine size suture materials to choose The introduction of fine sizes of from for keratoplasty, cataract, Nylon was the preferred suture sutures and needles has increased and vitreous retinal microsurgical material for ophthalmic surgery. the use of the operating microscope. procedures. In addition to While nylon is not absorbed, ETHICON introduced the first VICRYL* sutures, other monofila- progressive hydrolysis of nylon microsurgery sutures—ETHILON* ment suture materials including in vivo may result in gradual loss of sutures—in sizes 8-0 through ETHILON sutures, PROLENE tensile strength over time. Fine sizes 11-0. Since then, the microsurgery sutures, and PDS* II sutures may of absorbable sutures are currently line has expanded to include be used. Braided material such as used for many ocular procedures. PROLENE* sutures and coated virgin silk, black braided silk, Occasionally, the sutures are VICRYL* sutures. Literally all MERSILENE* sutures, and coated absorbed too slowly in muscle surgical specialties perform some VICRYL sutures are also available recessions and produce granulomas procedures under the operating for ophthalmic procedures. to the sclera. Too rapid absorption microscope, especially vascular and has, at times, been a problem in nerve anastomosis. UPPER ALIMENTARY cataract surgery. Because they TRACT PROCEDURES induce less cellular reaction than The surgeon must consider the upper alimentary tract from the mouth down to the lower Skin Galea esophageal sphincter to be a Skull FIGURE potentially contaminated area. 17 The gut is a musculomembranous canal lined with mucus membranes. LAYERS Final healing of mucosal wounds OF SUTURES SURROUNDING appears to be less dependent upon A DRAIN suture material than on the wound closure technique. The oral cavity and pharynx generally heal quickly if not infected. Fine size sutures are adequate in this Dura mater Brain area as the wound is under little tension. Absorbable sutures may be

* Trademark 36 THE SUTURE

preferred. Patients, especially children, usually find them more FIGURE comfortable. However, the surgeon 18 may prefer a monofilament Ocular muscles nonabsorbable suture under certain THE EYE circumstances. This option causes Conjunctiva less severe tissue reaction than multifilament materials in buccal Cornea mucosa, but also requires suture removal following healing. Sclera In cases involving severe periodontitis, VICRYL periodontal mesh may be used to promote tissue regeneration, a technique that enhances the regeneration and attachment of tissue lost due to periodontitis. VICRYL periodontal mesh, available in several shapes and Oral cavity FIGURE sizes with a preattached VICRYL 19 ligature, is woven from the same copolymer used to produce THE UPPER absorbable VICRYL* suture. As a ALIMENTARY synthetic absorbable, VICRYL* CANAL periodontal mesh eliminates the trauma associated with a second surgical procedure and reduces the risk of infection or inflammation associated with this procedure. The esophagus is a difficult organ Esophagus to suture. It lacks a serosal layer. The mucosa heals slowly. The thick muscular layer does not hold sutures well. If multifilament sutures are used, penetration through the FIGURE mucosa into the lumen should be 20 avoided to prevent infection. BRONCHIAL RESPIRATORY STUMP TRACT SURGERY CLOSURE Relatively few studies have been done on healing in the respiratory tract. Bronchial stump closure following lobectomy or pneumonec- tomy presents a particular challenge. Infection, long stumps, poor approximation of the transected CHAPTER 2 37

bronchus, and incomplete closure (i.e., air leaks) may lead to FIGURE 21 bronchopleural fistula. Avoidance of tissue trauma and maintenance CONTINUOUS of the blood supply to the area of STRAND closure are critical to healing. The SUTURING bronchial stump heals slowly, and IN VASCULAR sometimes not at all. Unless it is SURGERY closed tightly with strong, closely spaced sutures, air may leak into the thoracic cavity. Closure is usually achieved with mechanical devices, particularly staples. When sutures are used, polypropylene monofilament nonab- sorbable sutures are less likely to cause tissue reaction or harbor FIGURE infection. Silk suture is also 22 commonly used. Surgeons usually avoid absorbable sutures because SEATING A they may permit secondary leakage HEART VALVE as they lose strength. WITH ETHIBOND EXCEL SUTURE Monofilament nylon suture should also be avoided because of its potential for knot loosening.

CARDIOVASCULAR SURGERY Although definitive studies are few, blood vessels appear to heal rapidly. Most cardiovascular surgeons prefer to use synthetic nonabsorbable sutures for cardiac and peripheral vascular procedures. Lasting strength FIGURE and leakproof anastomoses are essen- 23 tial. Wire sutures are used on the sternum unless it is fragile, in which THE BUNNELL case absorbable sutures can be used. TECHNIQUE VESSELS Excessive tissue reaction to suture material may lead to decreased luminal diameter or to thrombus formation in a vessel. Therefore, the more inert synthetics including nylon and polypropylene are the materials of choice for vessel

* Trademark 38 THE SUTURE

anastomoses. Multifilament Clinical studies suggest that a EXCEL suture around the cuff of polyester sutures allow clotting to prolonged absorbable suture, such as the valve before tying the knots. occur within the interstices which PDS* II suture, may be ideal, giving Some surgeons routinely use helps to prevent leakage at the adequate short-term support while pledgets to buttress sutures in valve suture line. The advantages of a permitting future growth. surgery. They are used most material such as ETHIBOND* Following vascular trauma, mycotic commonly in valve replacement EXCEL sutures are its strength, aneurysms from infection are procedures to prevent the annulus durability, and slippery surface extremely serious complications. from tearing when the prosthetic which causes less friction when A suture may act as a nidus for valve is seated and the sutures are drawn through a vessel. Many an infection. In the presence of tied. They may also be used in heart surgeons find that PROLENE* infection, the chemical properties wall closure of penetrating injuries, sutures, PRONOVA* sutures, or of suture material can cause excising aneurysms, vascular graft silk are ideal for coronary artery extensive tissue damage which may surgery, and to add support when procedures because they do not reduce the tissue's natural ability the surgeon encounters extreme "saw" through vessels. to combat infection. Localized deformity, distortion, or tissue Continuous sutures provide a more sepsis can also spread to adjacent destruction at the annulus. leakproof closure than interrupted vascular structures, causing necrosis sutures in large vessel anastomoses of the arterial wall. Therefore, the URINARY TRACT SURGERY because the tension along the surgeon may choose a monofilament Closure of tissues in the urinary suture strand is distributed evenly suture material that causes only a tract must be leakproof to prevent around the vessel's circumference. mild tissue reaction and resists escape of urine into surrounding Interrupted monofilament sutures bacterial growth. tissues. The same considerations such as ETHILON* sutures, that affect the choice of sutures for PROLENE* sutures, or VASCULAR PROSTHESES the biliary tract affect the choice of PRONOVA* sutures are used for The fixation of vascular prostheses sutures for this area. Nonabsorbable microvascular anastomoses. and artificial heart valves presents an sutures incite the formation of cal- When anastomosing major vessels entirely different suturing challenge culi, and therefore cannot be used. in young children, special care than vessel anastomosis. The sutures Surgeons use absorbable sutures as a must be taken to anticipate the must retain their original physical rule, especially MONOCRYL* future growth of the patient. properties and strength throughout sutures, PDS II sutures, VICRYL* Here, the surgeon may use silk to the life of the patient. A prosthesis sutures, Coated VICRYL* sutures, its best advantage, because it loses never becomes completely incorpo- and chromic gut sutures. much of its tensile strength after rated into the tissue and constant The urinary tract heals rapidly. The approximately 1 year, and is usually movement of the suture line occurs. transitional cell epithelium migrates completely absorbed after 2 or more Coated polyester sutures are the over the denuded surfaces quickly. years. Continuous polypropylene choice for fixation of vascular Unlike other epithelium, the sutures have been used in children prostheses and heart valves because migrating cells in the urinary tract without adverse effects. The they retain their strength and undergo mitosis and cell division. continuous suture, when placed, integrity indefinitely. Epithelial migration may be found is a coil which stretches as the Either a continuous or interrupted along suture tracts in the body of child grows to accommodate the technique may be used for vessel to the bladder. The bladder wall changing dimensions of the blood graft anastomoses. regains 100% of its original tensile vessel. However, reports of stricture strength within 14 days. The rate of following vessel growth have To assist in proper strand identifica- collagen synthesis peaks at 5 days stimulated interest in use of a tion, many surgeons alternate green and declines rapidly thereafter. suture line which is one-half and white strands of ETHIBOND* continuous, one-half interrupted. CHAPTER 2 39

Thus, sutures are needed for only tissue and migrate into the wound. holding structure is no longer neces- 7 to 10 days. The junction heals first with scar sary. Referred to as a pull-out suture, tissue, then by replacement with it is brought out through the skin THE FEMALE GENITAL TRACT new tendon fibers. Close apposition and fastened over a polypropylene Surgery within this area presents of the cut ends of the tendon button. The Bunnell Technique certain challenges. First, it is usually (especially extensor tendons) suture can also be left in place. regarded as a potentially contaminat- must be maintained to achieve NUROLON* sutures, PROLENE* ed area. Second, the surgeon must good functional results. Both the sutures, PRONOVA* sutures and frequently work within a very suture material and the closure ETHIBOND* EXCEL sutures may restricted field. Endoscopic technique technique are critical for successful be used for connecting tendon to is frequently used in this area. Coated tendon repair. VICYL* suture is an excellent choice bone. Permanent wire sutures also to prevent bacterial colonization. The suture material the surgeon yield good results because healing is chooses must be inert and strong. slow. In periosteum, which heals Most gynecological surgeons prefer Because tendon ends can separate fairly rapidly, surgical gut or coated to use absorbable sutures for repair of due to muscle pull, sutures with a VICRYL sutures may be used. In incisions and defects. Some prefer great degree of elasticity should be fact, virtually any suture may be using heavy, size 1 surgical gut avoided. Surgical steel is widely used used satisfactorily in the periosteum. sutures, MONOCRYL sutures, or because of its durability and lack of VICRYL sutures. However, the elasticity. Synthetic nonabsorbable SUTURES FOR BONE stresses on the reproductive organs materials including polyester fibers, In repairing facial fractures, and the rate of healing indicate that polypropylene, and nylon may be monofilament surgical steel has proven these larger-sized sutures may only be used. In the presence of potential ideal for its lack of elasticity. Facial required for abdominal closure. infection, the most inert monofila- bones do not heal by callus formation, but more commonly by fibrous union. Handling properties, especially ment suture materials are preferred. The suture material must remain in pliability of the sutures used for The suture should be placed to place for a long period of time— internal use, are extremely cause the least possible interference perhaps months—until the fibrous important. Synthetic absorbable with the surface of the tendon, as tissue is laid down and remodeled. sutures such as VICRYL* sutures in this is the gliding mechanism. It Steel sutures immobilize the size 0 may be used for the tough, should also not interfere with the fracture line and keep the tissues in muscular, highly vascular tissues blood supply reaching the wound. good apposition. in the pelvis and vagina. These Maintenance of closed apposition tissues demand strength during of the cut ends of the tendons, Following median stemotomy, approximation and healing. Coated particularly extensor tendons, is surgeons prefer interrupted steel VICRYL* RAPIDE suture, for critical for good functional results. sutures to close. Sternum closure may example, is an excellent choice for The parallel arrangement of tendon be difficult. Appropriate tension must episiotomy repair. fibers in a longitudinal direction be maintained, and the surgeon must makes permanent and secure place- guard against weakening the wire. TENDON SURGERY ment of sutures difficult. Various Asymmetrical twisting of the wire may Tendon surgery presents several figure-of-eight and other types of cause it to buckle, fatiguing the metal, challenges. Most tendon injuries are suturing have been used successfully and ultimately causing the wire to due to trauma, and the wound may to prevent suture slippage and the break. Motion between the sides of be dirty. Tendons heal slowly. The formation of gaps between the cut the sternum will result, causing striated nature of the tissue makes ends of the tendon. postoperative pain and possibly suturing difficult. Many surgeons use the Bunnell dehiscence. Painful nonunion is Tendon repair fibroblasts are Technique. The suture is placed to another possible complication. (In derived from the peritendonous be withdrawn when its function as a osteoporotic patients, very heavy

* Trademark 40 THE SUTURE

closures (sterile tape). The wound should be packed to maintain a moist FIGURE environment. When the infection 24 has subsided, the surgeon can easily reopen the wound, remove the TACKING A packing and any tissue debris, and PROSTHETIC then close using the previously DEVICE IN POSITION TO inserted monofilament nylon suture. PREVENT MIGRATION IN THE NEXT SECTION The surgeon depends as much upon VICRYL sutures may be used to close when it reaches approximately 10 6 the quality and configuration of the the sternum securely.) bacteria per gram of tissue in an needle used as on the suturing immunologically normal host. material itself to achieve a successful The surgeon may use a bone anchor Inflammation without discharge closure. The relationship between to hold one end of a suture in place and/or the presence of culture- needles and sutures will be explored when needed (e.g., shoulder repair positive serous fluid indicate possible on the pages that follow. surgery). This involves drilling a hole infection. Presence of purulent in the bone and inserting the anchor, discharge indicates positive infection. REFERENCES which expands once completely 1. Mangram AJ, Horan TC, Pearson inside the bone to keep it from being Contaminated wounds can become ML, Silver LC, Jarvis WR. Guideline pulled out. infected when hematomas, necrotic for prevention of surgical site tissue, devascularized tissue, or large infection, 1999. Infection Control OTHER PROSTHETIC DEVICES amounts of devitalized tissue and Hospital Epidemiology. Often, it is necessary for the sur- (especially in fascia, muscle, and bone) 1999;20:247-278. geon to implant a prosthetic device are present. Microorganisms multiply 2. Gilbert P, McBain AJ, Storch ML, such as an automatic defibrillator or rapidly under these conditions, where Rothenburger SJ, Barbolt TA. Literature-based evaluation of the drug delivery system into a patient. they are safe from cells that provide potential risks associated with To prevent such a device from local tissue defenses. impregnation of medical devices and migrating out of position, it may be In general, contaminated wounds implants with triclosan. Surg tacked to the fascia or chest wall should not be closed but should be left Infection J. 2002;3(suppl1):S55-S63. with nonabsorbable sutures. open to heal by secondary intention 3. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro because of the risk of infection. CLOSING CONTAMINATED antibacterial evaluation of Coated Foreign bodies, including sutures, OR INFECTED WOUNDS VICRYL* Plus Antibacterial suture perpetuate localized infection. Contamination exists when (coated polyglactin 910 with Therefore, the surgeon's technique microorganisms are present, but in triclosan) using zone of inhibition and choice of suture is critical. insufficient numbers to overcome the assays. S Infection J. Nonabsorbable monofilament nylon 2002;3(suppl 1):S79-S87. body's natural defenses. Infection sutures are commonly used in exists when the level of contamina- anticipation of delayed closure of tion exceeds the tissue's ability to dirty and infected wounds. The defend against the invading sutures are laid in but not tied. microorganisms. Generally, Instead, the loose suture ends are held contamination becomes infection in place with PROXI-STRIP* skin CHAPTER 3

THE SURGICAL NEEDLE 42 THE SURGICAL NEEDLE

Necessary for the placement of Variations in needle geometries are stainless steel alloy needles are heat- sutures in tissue, surgical needles just as important as variations in treated to give them the maximum must be designed to carry suture suture sizes. Needle dimensions possible strength and ductility. material through tissue with must be compatible with suture ETHALLOY* needle alloy (Patent minimal trauma. They must be sizes, allowing the two to work No. 5,000,912) was developed for sharp enough to penetrate tissue in tandem. unsurpassed strength in precision with minimal resistance. They needles used in cardiovascular, should be rigid enough to resist ophthalmic, plastic, and microsurgi- bending, yet flexible enough to ELEMENTS OF cal procedures. It is produced bend before breaking. They must NEEDLE DESIGN economically without sacrificing be sterile and corrosion-resistant ductility or corrosion resistance. to prevent introduction of Needle design involves analyzing a A needle's strength is determined microorganisms or foreign bodies surgical procedure and the density by how it resists deformation into the wound. of the tissue involved in great detail. ETHICON engineers work during repeated passes through Comfort with needle security in the continuously to improve upon their tissue. Tissue trauma can be needleholder, the ease of passage needle line, sometimes making sub- induced if a needle bends during through tissue, and the degree of tle alterations resulting in a positive penetration and compromises tissue trauma that it causes all have an impact upon the procedure itself. apposition. Therefore, greater needle impact upon the overall results of strength equals less tissue trauma. surgical needle performance. This is The anatomy of the ideal surgical A weak needle that bends too easily especially true when precise cosmet- needle has three key factors that can compromise the surgeon's ic results are desired. make up the ideal needle. control and damage surrounding – Alloy tissue during the procedure. In – Geometry – tip and body addition, loss of control in needle The best surgical needles are: – Coating placement could result in an • Made of high quality stainless The combination of these attributes inadvertent needlestick. steel. is ETHICON Advanced Needle Manufacturers measure needle Technology. • As slim as possible without strength in the laboratory by compromising strength. ETHICON bending them 90° to determine the • Stable in the grasp of a Advanced Needle Technology needle's maximum strength. This is needleholder. referred to as the needle's "ultimate moment," and is more important to • Able to carry suture material Superior Alloy the needle manufacturer than to the through tissue with minimal surgeon. The most critical aspect of trauma. needle strength to the surgeon is • Sharp enough to penetrate tissue the "surgical yield" point. Surgical with minimal resistance. yield indicates the amount of A.N.T. angular deformation the needle • Rigid enough to resist bending, Superior Superior can with-stand before becoming Geometry Coating yet ductile enough to resist permanently deformed. This point breaking during surgery. is usually 10° to 30° depending • Sterile and corrosion-resistant upon the material and the manufac- to prevent introduction of The various metal alloys used in the turing process. Any angle beyond microorganisms or foreign manufacture of surgical needles that point renders the needle materials into the wound. determine their basic characteristics useless. Reshaping a bent needle to a great degree. ETHICON* may cause it to lose strength CHAPTER 3 43 and be less resistant to bending Needle bending and breakage can Most ETHICON needles have and breaking. be minimized by carefully passing a micro-thin coating comprised needles through tissue in the of silicone or similar lubricants At ETHICON, the combination direction of the needle body. which significantly and measurably of alloy selection and the needle Needles are not designed to be improves ease of needle penetration. manufacturing process are carefully used as retractors to lift tissue. According to laboratory tests, this selected to achieve the highest coating serves several important possible surgical yield, which also Needle sharpness is especially functions: optimizes needle strength. important in delicate or cosmetic surgery. The sharper the needle, ✦ It reduces the force needed to Ductility refers to the needle's the less scarring that will result. make the initial penetration resistance to breaking under a given However, the right balance must be through tissue. amount of bending. If too great a found. If a needle is too sharp, a force is applied to a needle it may ✦ It reduces the drag force on surgeon may not feel he or she has break, but a ductile needle will the needle body as it passes adequate control of needle passage bend before breaking. Needle repeatedly through tissue. through tissue. breakage during surgery can prevent Needle performance is also apposition of the wound edges as Sharpness is related to the angle of influenced by the stability of the the broken portion passes through the point as well as the taper ratio needle in the grasp of a needlehold- tissue. In addition, searching for of the needle. The ETHICON er. Most curved needles are part of a broken needle can cause sharpness tester incorporates a thin, flattened in the grasping area to added tissue trauma and add to the laminated, synthetic membrane enhance control. All ETHICON time the patient is anesthetized. A that simulates the density of human curved needles of 22 mil wire piece that cannot be retrieved will tissue, allowing engineers to gauge or heavier are ribbed as well as remain as a constant reminder to exactly how much force is required flattened. Longitudinal ribbing both the patient and surgeon. for penetration. or grooves on the inside or outside curvatures of curved needles provides a crosslocking action in the needleholder for added needle FIGURE control. This reduces undesirable 12:1 ratio 1 rocking, twisting, and turning in the needleholder. TAPER RATIO PRINCIPLES OF CHOOSING A SURGICAL NEEDLE FIGURE While there are no hard and fast 2 rules governing needle selection, the following principles should be kept ETHICON in mind. (Specific types of needles RIBBED NEEDLE mentioned here will be described in full detail later on in this section.) 1. Consider the tissue in which the surgeon will introduce the needle. Generally speaking, taper

* Trademark 44 THE SURGICAL NEEDLE

point needles are most often used 2. Watch the surgeon's technique individual routine. However, to suture tissues that are easy closely. Select the length, even the same surgeon may need to penetrate. Cutting or diameter, and curvature of the to change needle type or size to TAPERCUT* needles are needle according to the desired meet specific requirements, more often used in tough, hard- placement of the suture and the even during a single operative to-penetrate tissues. When in space in which the surgeon procedure. doubt about whether to choose is working. 4. When using eyed needles, try to a taper point or cutting needle, 3. Consult frequently with the match needle diameter to suture choose the taper point for surgeon. Working with the same size. Swaged needles, where the everything except skin sutures. surgeon repeatedly leads to needle is already attached to the familiarity with his or her suture strand, eliminate this concern. 5. The best general rule of thumb for the scrub person to follow is FIGURE pay attention and remain alert to 3 Point the progress of the operation.

NEEDLE Observation is the best guide to COMPONENTS needle selection if the surgeon has no preference.

Eye THE ANATOMY (Swaged end) OF A NEEDLE Regardless of its intended use, every surgical needle has three basic Body components: ✦ The eye. ✦ The body. ✦ The point. The measurements of these specific components determine, in part, how they will be used FIGURE most efficiently. Needle Chord length 4 point Swage Needle size may be measured in inches or in metric units. The ANATOMY following measurements determine OF A NEEDLE the size of a needle. Needle ✦ CHORD LENGTH—The radius straight line distance from the point of a curved needle to Needle diameter the swage. Needle length ✦ NEEDLE LENGTH—The Needle body distance measured along the needle itself from point to end. CHAPTER 3 45

✦ RADIUS—The distance from Virtually all needles used today are 4. Tissue trauma is further reduced the center of the circle to the swaged. This configuration joins because a new, sharp, undamaged body of the needle if the the needle and suture together as needle is provided with each curvature of the needle were a continuous unit—one that is suture strand. convenient to use and minimizes continued to make a full circle. 5. Swaged sutures do not unthread trauma. The method of attaching ✦ DIAMETER—The gauge or prematurely. thickness of the needle wire. the suture to the needle varies with 6. If a needle is accidentally Very small needles of fine gauge the needle diameter. In larger dropped into a body cavity, the are needed for microsurgery. diameter needles, a hole is drilled attached suture strand makes it Large, heavy gauge needles are in the needle end. In smaller easier to find. used to penetrate the sternum diameter needles, a channel is and to place retention sutures made by forming a "U" at the 7. Inventory and time spent in the abdominal wall. A broad swage end or a hole is drilled in cleaning, sharpening, handling, spectrum of sizes are available the wire with a laser. Each hole or and sterilizing reusable eyed between the two extremes. channel is specifically engineered needles is eliminated, thereby for the type and size of suture reducing cost as well as risk of THE NEEDLE EYE material it will hold, and crimped needle punctures. The eye falls into one of three cate- or closed around the suture to hold 8. CONTROL RELEASE needles gories: closed eye, French (split or it securely. When the surgeon has allow placement of many sutures spring) eye, or swaged (eyeless). finished placing the suture line in rapidly. This may reduce The closed eye is similar to a the patient's tissue, the suture may operating time and, ultimately, household sewing needle. The shape be cut, or easily released from the the length of time the patient of the eye may be round, oblong, needle as is the case when using is anesthetized. or square. French eye needles have a CONTROL RELEASE* needles (Patent No. 3,980,177). 9. The ATRALOC* surgical needle slit from inside the eye to the end and CONTROL RELEASE of the needle with ridges that catch The diameter of a needle swaged needle ensure consistent quality and hold the suture in place. to suture material is no larger and performance. Eyed needles must be threaded, a than necessary to accommodate the diameter of the suture strand 10. Swaged sutures eliminate suture time-consuming procedure for the fraying or damage due to sharp scrub person. This presents the itself. Swaged sutures offer several advantages to the surgeon, nurse, comers in the eye of eyed disadvantage of having to pull a needles. double strand of suture material and patient. 11. Needles are corrosion-free. through tissue, creating a larger hole 1. The scrub person does not have with additional tissue disruption. to select a needle when the Small diameter ETHICON taper In addition, the suture may still surgeon requests a specific suture point needles commonly used become unthreaded while the material since it is already in cardiovascular surgery were surgeon is using it. While tying the attached. compared in laboratory tests— suture to the eye may minimize this 2. Handling and preparation are some with "split" channels and possibility, it also adds to the bulk minimized. The strand with some with laser-drilled holes. The of the suture. Another disadvantage needle attached may be used needles with laser-drilled holes of eyed needles is that repeated use directly from the packet. This produced less drag force as they of these needles with more than helps maintain the integrity of passed through a membrane that one suture strand causes the needle the suture strand. simulated vascular tissue. This to become dull, thereby making could be associated with less suturing more difficult. 3. Tissues are subjected to minimal trauma to the vessel walls. trauma.

* Trademark 46 THE SURGICAL NEEDLE

hysterectomies, but is now used finger-held manipulation can easily THE NEEDLE EYE FIGURE in a wide variety of procedures. be performed. 5 The Keith needle is a straight THE NEEDLE BODY cutting needle. It is used primarily The body of the needle is the for skin closure of abdominal portion which is grasped by the wounds. Varying lengths are also needleholder during the surgical used for arthroscopic suturing of procedure. The body of the needle the meniscus in the knee. should be as close as possible to the Closed eye diameter of the suture material to Bunnell (BN) needles are used for minimize bleeding and leakage. tendon repair. Taper point needle This is especially true for variations may also be used for cardiovascular, gastrointestinal, suturing the gastrointestinal tract. and bladder procedures. Some microsurgeons prefer straight The curvature of the needle body needles for nerve and vessel repair. may come in a variety of different In ophthalmology, the straight tran- shapes. Each shape gives the needle schamber needle protects endothe- different characteristics. lial cells and facilitates placement of French eye intraocular lenses. STRAIGHT NEEDLE This shape may be preferred when HALF-CURVED NEEDLE suturing easily accessible tissue. The half-curved or "ski" needle Most of these needles are designed may be used for skin closure or in to be used in places where direct laparoscopy. Its low profile allows

FIGURE Swaged 6

The swaged ATRALOC surgical CONTROL needles made by ETHICON RELEASE are supplied in a variety of sizes, NEEDLE shapes, and strengths. Some of SUTURE them incorporate the CONTROL RELEASE needle suture principle which facilitates fast separation of the needle from the suture when desired by the surgeon. This feature allows rapid placement of many sutures, as in interrupted suturing techniques. Even though the suture is securely fastened to the needle, a slight, straight tug will release it. This needle/suture configuration was created originally Holding the needle securely in the needleholder, the suture for abdominal closure and should be grasped securely and pulled straight and taut. The needle will be released with a straight tug of the needleholder. CHAPTER 3 47 easy passage down laparoscopic space for maneuvering than a The 1/2 circle needle was designed trocars. Its use in skin closure is straight needle, but the curve for use in a confined space, limited because, while the curved necessitates manipulation with a although it requires more pronation portion passes through tissue easily, needleholder. The curvature may and supination of the wrist. But the remaining straight portion of be 1/4, 3/8, 1/2, or 5/8 circle. even the tip of this needle may the body is unable to follow the The most common use for the 3/8 be obscured by tissue deep in curved path of the needle without circle is skin closure. The surgeon the pelvic cavity. A 5/8 circle bending or enlarging its path in can easily manipulate this curvature needle may be more useful in the tissue. with slight pronation of the wrist in this situation, especially in some a relatively large and superficial anal, urogenital, intraoral, and CURVED NEEDLE wound. It is very difficult to use cardiovascular procedures. Curved needles allow predictable this needle in a deep body cavity or needle turnout from tissue, and restricted area because a larger arc of COMPOUND are therefore used most often. manipulation is required. CURVED NEEDLE This needle shape requires less The compound curved needle (Patent No. 4,524,771) was SHAPE APPLICATION originally developed for anterior segment ophthalmic surgery. It Straight gastrointestinal tract, nasal FIGURE cavity, nerve, oral cavity, 7 allows the surgeon to take precise, pharynx, skin, tendon, vessels uniform bites of tissue. The tight NEEDLE 80° curvature of the tip follows into SHAPES a 45° curvature throughout the AND TYPICAL Half-curved skin (rarely used) APPLICATIONS remainder of the body. The initial laparoscopy curve allows reproducible, short, deep bites into the tissue. The curvature of the remaining portion of the body forces the needle out of 1/4 Circle eye (primary application) microsurgery the tissue, everting the wound edges and permitting a view into the wound. This ensures equidistance of the suture material on both sides of 3/8 Circle aponeurosis, biliary tract, cardiovascular the incision. Equalized pressure on system, dura, eye, gastrointestinal tract, muscle, myocardium, nerve, perichon- both sides of the comeal-scleral drium, periosteum, pleura, skin, tendon, junction minimizes the possibility urogenital tract, vessels of astigmatism following anterior segment surgery. 1/2 Circle biliary tract, cardiovascular system, eye, fascia, gastrointestinal tract, muscle, nasal cavity, oral cavity, pelvis, peri- toneum, pharynx, pleura, resporatory THE NEEDLE POINT tract, skin, tendon, subcutaneous fat, urogenital tract The point extends from the extreme tip of the needle to the maximum 5/8 Circle anal (hemorrhoidectomy), nasal cavity, pelvis, urogenital tract (primary cross-section of the body. Each nee- application) dle point is designed and produced to the required degree of sharpness Compound eye (anterior segment) to smoothly penetrate specific types Curved laparoscopy of tissue.

* Trademark 48 THE SURGICAL NEEDLE

TYPES OF SHAPE APPLICATION NEEDLES Conventional Cutting skin, sternum FIGURE 8 CUTTING NEEDLES Point Cutting needles have at least two NEEDLE opposing cutting edges. They are Body POINTSAND sharpened to cut through tough, BODY SHAPES Reverse Cutting fascia, ligament, nasal cavity, oral AND TYPICAL difficult-to-penetrate tissue. mucosa, pharynx, skin, tendon sheath Cutting needles are ideal for skin APPLICATIONS Point sutures that must pass through dense, irregular, and relatively Body thick connective dermal tissue. Precision Point Cutting skin (plastic or cosmetic) Because of the sharpness of the Point cutting edge, care must be taken

in some tissue (tendon sheath Body or oral mucous membrane) to avoid cutting through more tissue PC PRIME* Needle skin (plastic or cosmetic) than desired. Point

CONVENTIONAL Body CUTTING NEEDLES MICRO-POINT* Reverse Cutting Needle eye In addition to the two cutting edges, conventional cutting needles have a Point third cutting edge on the inside Body concave curvature of the needle. The shape changes from a triangular Side-Cutting Spatula eye (primary application), Point microsurgery, ophthalmic cutting blade to that of a flattened (reconstructive) body on both straight and curved Body needles. This needle type may be

prone to cutout of tissue because CS ULTIMA* Ophthalmic Needle eye (primary application)

the inside cutting edge cuts toward Point the edges of the incision or wound. Body The PC PRIME* needle (Precision Cosmetic, Patent No. 5,030,228) Taper aponeurosis, biliary tract, dura, fascia, is designed specifically for aesthetic gastrointestinal tract, laparoscopy, Point plastic surgery, and has conventional muscle, myocardium, nerve, peritoneum, pleura, subcutaneous fat, urogenital cutting edges. Where cosmetic Body tract, vessels, valve results are important, the PC PRIME needle is superior to any TAPERCUT* Surgical Needle bronchus, calcified tissue, fascia, laparoscopy, ligament, nasal cavity, other for more delicate surgery, Point oral cavity, ovary, perichondrium, especially facial surgery. The periosteum, pharynx, sternum, tendon, trachea, uterus, valve, vessels (sclerotic) narrow point, fine wire diameter, Body

and fine taper ratio allow superior Blunt Blunt dissection (friable tissue), penetration of soft tissue. The inside Point cervix (ligating incompetent cervix), and outside curvatures of the body fascia, intestine, kidney, liver, spleen

are flattened in the needle grasping Body CHAPTER 3 49 area for greater stability in the ✦ The hole left by the needle leaves This results in superior apposition. needleholder. Fattened sides reduce a wide wall of tissue against The bottom third cutting edge bending that might occur due to which the suture is to be tied. on the Precision Point needle the fine wire diameter. flattens out as it transitions to the The MICRO-POINT* surgical needle body for greater security in The tip configuration of the conven- needle for ophthalmic procedures the needleholder. tional cutting sternotomy needle is has a smooth surface and is honed The OS (Orthopaedic Surgery) slightly altered to resist bending as it to extreme sharpness. This allows needles are curved, heavy bodied, penetrates the sternum. The alloy the surgeon to suture the extremely reverse-cutting needles. The used for this needle provides the tough tissues of the eye with orthopaedic surgeon may use the increased strength and ductility need- optimum precision and ease. OS needle for extremely tough ed for its function. The cutting edges A needle manufactured by the tissue, such as cartilage, where force of the point extend approximately exclusive ETHICON* Precision is required for penetration. 1/4" (6mm) from the round body Point Process may be used for and terminate in a triangular-shaped plastic or cosmetic surgery, and SIDE CUTTING NEEDLES tip. This particular sternotomy needle passes smoothly through tissue Also referred to as spatula needles, maximizes cutting efficiency and con- creating a minute needle path. they feature a unique design which trol in the needleholder. TAPERCUT surgical needles may also be used for this procedure. FIGURE REVERSE CUTTING Narrow point 9 NEEDLES Fine wire diameter These needles were created THE PC PRIME specifically for tough, difficult-to- NEEDLE penetrate tissue such as skin, tendon sheath, or oral mucosa. Reverse Flattened inside curvature cutting needles are used in ophthalmic and cosmetic surgery where minimal trauma, early Flat sides regeneration of tissue, and little scar Conventional formation are primary concerns. cutting tip The reverse cutting needle is as Flattened outside curvature sharp as the conventional cutting needle, but its design is distinctively different. The third cutting edge is located on the outer convex Conventional cutting edges (1/4 inch or 6mm) FIGURE curvature of the needle. This offers 10 several advantages: ✦ Reverse cutting needles have STERNOTOMY more strength than similar-sized NEEDLE conventional cutting needles. ✦ The danger of tissue cutout is greatly reduced.

* Trademark 50 THE SURGICAL NEEDLE

is flat on both the top and bottom, eliminating the undesirable tissue FIGURE cutout of other cutting needles. 11 The side-cutting edges are designed for ophthalmic procedures. They REVERSE permit the needle to separate or CUTTING split through the thin layers of NEEDLE scleral or comeal tissue and travel within the plane between them. The optimal width, shape, and precision sharpness of this needle ensure maximum ease of penetra- tion, and gives the surgeon greater control of the needle as it passes between or through tissue layers. The position of the point varies with the design of each specific type of spatulated needle. FIGURE The SABRELOC* spatula needle 12 has two cutting edges and a trapezoidal-shaped body. SPATULA The SABRELOC* needle with NEEDLE the cobra-shaped tip has four CROSS- equidistant defined edges. SECTION The CS ULTIMA* ophthalmic needle (Corneal-Scleral, Patent No. 5,002,564) is the sharpest needle in its category and is used for corneal scleral closure. The smaller angles and increased cutting-edge length result in superior sharpness facilitating easy tissue penetration. The needle body then flattens to an to prevent leakage which can The TG PLUS* needle (Transverse oval or rectangular shape. This subsequently lead to contamination Ground) has a long, ultra-sharp, increases the width of the body to of the abdominal cavity. In the slim tip. This needle undergoes a help prevent twisting or turning in fascia, taper point needles minimize unique honing process which results the needleholder. the potential for tearing the thin connective tissue lying between in a sharper needle. The surgeon Taper point needles are usually parallel and interlacing bands of encounters low penetration resist- used in easily penetrated tissue denser, connective tissue. ance with the TG PLUS needle, and such as the peritoneum, abdominal gets excellent tactile feedback. viscera, myocardium, dura, and The Mayo (MO) needle has a taper subcutaneous layers. They are point, but a heavier and more TAPER POINT NEEDLES preferred when the smallest possible flattened body than conventional Also referred to as round needles, hole in the tissue and minimum taper needles. This needle was taper point needles pierce and tissue cutting are desired. They are designed for use in dense tissue; spread tissue without cutting it. The also used in internal anastomoses particularly for gynecological needle point tapers to a sharp tip. CHAPTER 3 51 procedures, general closure, and Although initially designed for risk of leakage from friable vessels hernia repair. use in cardiovascular surgery on or vascular graft material. sclerotic or calcified tissue, the TAPERCUT SURGICAL TAPERCUT* needle is widely BLUNT POINT NEEDLES NEEDLES used for suturing dense, fibrous Blunt point (BP) needles can ETHICON* manufactures TAPER- connective tissue— especially in literally dissect friable tissue rather CUT* needles which combine the fascia, periosteum, and tendon than cutting it. They have a taper features of the reverse cutting edge where separation of parallel body with a rounded, blunt point tip and taper point needles. Three connective tissue fibers could occur that will not cut through tissue. cutting edges extend approximately with a conventional cutting needle. They may be used for suturing the 1/32" back from the point. These liver and kidney. Due to safety ETHICON* developed a modified blend into a round taper body. All considerations, surgeons also use TAPERCUT CC needle (Calcified three edges are sharpened to provide blunt point needles in obstetric Coronary) for anastomosis of small uniform cutting action. The point, and gynecological procedures when fibrotic and calcified blood vessels. sometimes referred to as a trocar working in deep cavities which The calcified portion of an artery point, readily penetrates dense, are prone to space and visibility requires a cutting tip only for initial tough tissue. The objective should limitations. In addition, blunt penetration to avoid tearing the be for the point itself not to exceed point needles for general closure are vessel. This needle configuration has the diameter of the suture material. especially helpful when performing a slimmer geometry than other The taper body portion provides procedures on at-risk patients. TAPERCUT needles from the body smooth passage through tissue and through the point which facilitates The ETHIGUARD* blunt point eliminates the danger of cutting penetration. It also minimizes the needle combines the safety of the into the surrounding tissue. blunt point with the security of a

CODE MEANING CODE MEANING CODE MEANING TABLE BB Blue Baby FSLX For Skin Extra Large STB Straight Blunt 1 BIF Intraocular Fixation G Greishaber STC Straight Cutting BN Bunnell GS Greishaber Spatula STP Straight Taper Point BP Blunt Point J Conjunctive TE Three-Eighths ETHICON BV Blood Vessel KS Keith Straight TF Tetralogy of Fallot BVH Blood Vessel Half LH Large Half TG Transverse Ground NEEDLE C Cardiovascular LR Larger Retention TGW Transverse Ground Wide CODES CC Calcified Cornary LS Large Sternotomy TN Trocar Needle & OTHER CCS Conventional Cutting Sternotomy M Muscle TP Taper Pericostal / Point MEANING CE Cutting Edge MF Modified Fergusan TPB Taper Pericostal /Point Blunt CFS Conventional for Skin MH Medium Half (circle) TS Tendon Straight CIF Cutting Intraocular Fixation MO Mayo TQ Twisty Q CP Cutting Point MOB Mayo Blunt UCL 5/8 Circle Colateral Ligament CPS Conventional Plastic Surgery OPS Ocular Plastic Surgery UR Urology CPX Cutting Point Extra Large OS Orthopaedic Surgery URB Urology Blunt CS Corneal-Scleral P Plastic V TAPERCUT Surgical Needle CSB Corneal-Scleral Bi-Curve PC Precision Cosmetic VAS Vas Deferens CSC Corneal-Scleral Compound Curve PS Plastic Surgery X or P Exodontal (dental) CT Circle Taper RB Renal (artery) Bypass XLH Extra Large Half (circle) CTB Circle Taper Blunt RD Retinal Detachment XXLH Extra Extra Large Half (circle) CTX Circle Taper Extra Large RH Round Half (circle) CTXB Circle Taper Extra Large Blunt RV Retinal-Vitreous CV Cardiovascular S Spatula DC Dura Closure SC Straight Cutting DP Double Point SFS Spatulated for Skin EN Endoscopic Needle SH Small Half (circle) EST Eyed Straight Taper SIF Ski Intraocular Fixation FN For Tonsil SKS Sternotomy Keith Straight FS For Skin SM Spatulated Module FSL For Skin Large ST Straight Taper

* Trademark 52 THE SURGICAL NEEDLE

ribbed and flattened design, and the convenience of a swaged needle. FIGURE 11 NEEDLEHOLDERS REVERSE The surgeon uses the needleholder CUTTING to pass a curved needle through NEEDLE tissue. It must be made of noncor- rosive, high strength, good quality steel alloy with jaws designed for holding the surgical needle securely.

Smooth Jaws Jaws with tungsten Jaws with Needleholder jaws may be short or carbide particles teeth flat, concave or convex, smooth or serrated. Smooth jaws may allow the needle to wobble or twist. Jaws with heavier the jaws of the needle- 4. Handle the needle and needle- teeth hold most securely but may holder should be. holder as a unit. damage the suture or needle if too ✦ It should be an appropriate size 5. Pass the needleholder to the much pressure is applied. Most, but for the procedure. If the surgeon surgeon so that he or she will not not all, needleholders have a ratchet is working deep inside the body have to readjust it before placing lock near to thumb and finger rings. cavity, a longer needleholder is the suture in tissue. Make sure Surgical needles are designed for in order. the needle is pointing in the optimum needleholder stability. direction in which it will be Because this tool actually drives the NEEDLEHOLDER USE used and that the suture strand is needle, its performance will have an The following guidelines are offered not entangled. impact upon the entire suturing to the scrub person for needleholder 6. Always provide a needleholder— procedure. The surgeon has maxi- use: never a hemostat—to pull the mum control only when the needle 1. Grasp the needle with the tip of needle out through tissue. A sits well in the holder without wob- the needleholder jaws in an area hemostat or other clamp can bling as it is passed through tissue. approximately one-third to damage the needle. Needleholders, like pliers, weaken one-half of the distance from the 7. Immediately after use, every with repeated use. Therefore, the swaged end to the point. Avoid needle should be returned to the scrub person should check before placing the holder on or near the scrub person while clamped in a each procedure to make sure that swaged area which is the weakest needleholder. Needles are less the needleholder jaws align properly part of the needle. likely to be lost if they are passed and grasp securely. 2. Do not grasp the needle too one-for-one (one returned for When selecting a needleholder, tightly as the jaws of the needle- each one received). the following should be taken holder may deform, damage, or into consideration: bend it irreversibly. PLACING THE NEEDLE IN TISSUE ✦ It must be the appropriate size 3. Always check alignment of the needleholder jaw to make certain The actual placement of the for the needle selected. A very needle in the patient's tissue can small needle should be held with the needle does not rock, twist, or turn. cause unnecessary trauma if done small, fine jaws. The larger and incorrectly. Keep the following in heavier the needle, the wider and mind during suturing: CHAPTER 3 53

1. Apply force in the tissue to be sutured in the same direction as FIGURE the curve of the needle. 14 2. Do not take excessively large bites of tissue with a small needle. PLACEMENT OF THE 3. Do not force a dull needle NEEDLE IN through tissue. Take a new 1. The surgeon receives the 2. The surgeon begins closure TISSUE needle. needleholder with the needle with theswaged suture. point toward the thumb to 4. Do not force or twist the needle prevent unnecessary wrist motion. The scrub person in an effort to bring the point controls the free end of the out through the tissue. Withdraw suture to prevent dragging it across the sterile field, and to the needle completely and then keep the suture from entering the surgeon’s hand along replace it in the tissue, or use a with the needleholder. larger needle. 5. Avoid using the needle to bridge or approximate tissues for suturing. 6. Do not damage taper points or cutting edges when using the needleholder to pull the needle through tissue. Grasp as far back 3. The needle is passed into the tissue. The surgeon releases the needle from the holder and reclamps the holder onto the body of the on the body as possible. needle near the point end to pull the needle and strand through tissue. The needle is released or cut from the suture strand. The 7. Depending upon the patient, the surgeon leaves the needle clamped in the same position and returns tissue may be tougher or more it to the scrub person. The scrub person immediately passes another prepared suture to the surgeon, one-for-one. fibrous than anticipated and require the use of a heavier gauge should be undertaken for break suture strands. Also check needle. Conversely, a smaller transmissable agents such as the eyes for burrs or bluntness to needle may be required when hepatitis B and C and HIV. ensure easy penetration and tissue is more friable than usual. passage through tissue. 8. In a deep, confined area, ideal 4. If a needle is defective, discard it. positioning of the needle may NEEDLE 5. Pass needles on an exchange not be possible. Under these HANDLING TIPS basis; one is passed to the circumstances, proceed with Needles should be protected from surgeon for one returned. caution. A heavier gauge needle bacterial contamination and damage or a different curvature may help during handling by adhering to the 6. Employ the nontransfer and a second needleholder following guidelines: technique to avoid inadvertent needlesticks: the surgeon places should be used to locate a needle 1. Open needle packets and prepare the needle and needleholder in a confined body cavity. sutures carefully, protecting down in a neutral area of the 9. If a glove is punctured by a needle sharpness. sterile field; the scrub person needle, the needle must be 2. Make sure the needle is free then picks up the needleholder. discarded immediately and the of corrosion. glove must be changed for the 7. Secure each needle as soon as it is safety of the patient, as well as 3. If using eyed needles, make sure used. Do not allow needles to lie the surgical team. Appropriate they do not have rough or sharp loose on the sterile field or Mayo serological testing of the patient edges inside the eye to fray or stand. Keep them away from

* Trademark 54 THE SURGICAL NEEDLE

sponges and tapes so they will IN THE not inadvertently be dragged into NEXT SECTION the wound. 8. If a needle breaks, all pieces must In the section that follows, the be accounted for. dual role that suture and needle packaging plays will be covered. 9. Count all needles before and after Packaging does much more than use according to hospital keep the needle and suture sterile. procedure. Retain the packets Package design can help or containing descriptive informa- seriously hinder the efficiency of tion on quantity and needle type the surgical procedure. for swaged needles to help determine if all are accounted for.

Follow these steps for safe needle handling: 1. Use sterile adhesive pads with or without magnets or disposable magnetic pads to facilitate counting and safe disposal. 2. Swaged needles can be inserted through or into their original packet after use. An empty packet indicates a missing needle. If using an E-PACK* procedure kit, compare the count of needles used to the number preprinted on the kit label. 3. Return eyed needles to the needle rack. If eyed needles are to be reused, they must be cleaned and reprocessed at the end of the operation. 4. Do not collect used needles in a medicine cup or other container since they must then be handled individually to count them. This can potentially contaminate gloves and increase the risk of an accidental puncture. 5. Discard used needles in a "sharps" container. CHAPTER 4

PACKAGING 56 PACKAGING

AN INTEGRAL PART 3. Provide identifiable product needle counting, and cost contain- OF THE PRODUCT information. ment. The RELAY suture system 4. Permit convenient, safe, and consists of three basic, interrelated The purpose of a package is to sterile transfer of the product components: modular suture protect its contents and provide from the package to the storage racks, dispenser boxes, convenience to the user. sterile field. and primary packets. ETHICON* wound closure 5. Meet the functional needs of all packaging is an integral part of members of the surgical team. MODULAR STORAGE RACKS each product. Over the past half a The modular storage racks are century, packaging has evolved designed for maximum convenience from glass tubes packed in jars, RELAY* SUTURE and versatility to meet the individ- to multi-layered foil and paper DELIVERY SYSTEM ual needs of a particular specialty, packages, to new materials that nurse, surgeon, or department. reflect concern for both the Most suture materials are packaged Modules can be easily assembled environment and the individuals and sterilized by the manufacturer. to accommodate both vertical and who must maintain operative They arrive ready for use in boxes horizontal suture dispenser boxes. sterility and efficiency. Packaging which can be stored until needed. Any number of modules can be has kept pace with the technological The RELAY* suture delivery system, fastened together to meet both developments of wound closure developed by ETHICON with small and large storage needs. products themselves. Several factors human, clinical, and environmental Once assembled, the racks may be have influenced these developments: factors in mind, stores and delivers used on shelves, mounted on walls, ✦ Increasing product diversity sutures in a time-efficient manner placed on mobile carts, or and reduces unnecessary handling connected to IV poles. Racks can ✦ Technological advances in to access sutures. The system also be fitted with a rotating base packaging materials also provides control over suture for more convenient access, as well ✦ Stringent regulatory requirements storage, usage, inventory rotation, as with a handle for easy carrying. To prevent infection in an operative wound, all instruments and supplies that come in contact with the FIGURE wound must be sterile (free of 1 living microorganisms and spores) including sutures, needles, ligating ETHICON clips, stapling instruments, adhesive MODULAR tapes and topical skin adhesives. STORAGE High standards and criteria are set RACKS for all components in the packaging Full-vertical boxes Half-vertical boxes of sterile products: 1. Protect and preserve product stability and sterility from potential deterioration from outside forces such as oxygen, moisture, light, temperature, dust, and vermin. 2. Prevent product damage or microbial contamination in transit and storage. Horizontal boxes Combination of boxes CHAPTER 4 57

Each module has a built-in (single- or double-armed, shown exterior surfaces of the overwrap are inventory control area to facilitate by silhouette) not sterile. ETHICON primary restocking. This feature enables 6. Needle point geometry packaging is designed to permit fast unused suture packets to be 7. Lot number and easy opening in one peelable systematically fed back into the 8. Expiration date motion. The single layer overwrap proper rotational flow without of primary packaging is made of A package insert with detailed infor- mixing lots within the boxes. either foil or coated Tyvek® on one mation about the suture material is Sutures may be grouped within side heat-sealed to polyethylene film inserted in every dispenser box. Users the modular system by material on the other. Absorbable sutures are should be familiar with this informa- type or size, or by use (i.e., general always encased in foil to provide a tion as it contains FDA-approved closure, gastrointestinal surgery, safe and durable moisture barrier indications, contraindications, and plastic surgery, etc.). and to withstand sterilization in all appropriate warnings and precau- the manufacturing process. Most tionary statements for each product. DISPENSER BOXES nonabsorbable sutures are encased Gravity-fed dispenser boxes dispense Dispenser boxes should be restocked in coated Tyvek® overwraps. suture packets from the opening at when the last few suture packets In a continuous effort to be more the bottom of the box. The opening appear in the box opening, before environmentally conscious, can accommodate the removal of the box is completely empty. The ETHICON has chosen materials several suture packets at one time. unused packets from the previous in the manufacture of primary box should be used before a new All ETHICON* dispenser boxes packets which generate minimal dispenser box is opened. This will are made of recyclable paper negative impact to the environment help to avoid mixing lot numbers and printed with either water or upon incineration or disposal. and ensure proper stock rotation. soy-based inks. Each box provides Furthermore, wherever possible, ETHICON advocates rotation clear product identification through the number of primary packaging of the entire dispenser box. In streamlined graphics, product layers has been reduced by as addition to ensuring the use of the color coding, bold label copy, much as 50 percent, thus reducing oldest suture materials first, this and descriptive symbols. The the volume of environmental waste helps to maintain a fresh stock of information required for quick per OR procedure. dispenser boxes. reference and easy selection of Each primary packet provides suture materials is highlighted in a Most dispenser boxes contain critical product information and logical sequence. The three most three dozen suture packets. Others the same color-coding as its important criteria necessary for may contain one or two-dozen dispenser box. The packet also proper identification and suture packets. The product code number identifies the product code number, selection are: suffix and a statement on the box material, size, needle type, and the 1. Suture size indicate the quantity of suture number of needles per packet to 2. Suture material packets in the box (product code simplify needle counts. 3. Type and size of needle suffix G = 1 dozen, D = 1 dozen, T = 2 dozen, H = 3 dozen). The Primary packets of suture material Other important product dispenser boxes are held securely for may contain sutures in one of information found on all suture easy dispensing by firmly pushing five styles: boxes includes: the box into a "lock" in the back of 1. Standard lengths of non-needled 1. Surgical application the rack module. material: 54 inches (135cm) of 2. Product code number absorbable or 60 inches (150cm) 3. Suture length and color PRIMARY PACKETS of nonabsorbable suture, which 4. Metric diameter equivalent of Individual sutures and multiple may be cut in half, third, or suture size and length suture strands are supplied sterile quarter lengths for ligating 5. Shape and quantity of needles within a primary packet. The or threading. * Trademark 58 PACKAGING

2. SUTUPAK* pre-cut sterile suture ABSORBABLE SUTURE LAYERS is nonneedled material for ligating or threading. These Surgical Gut Suture Tyvek ® overwrap, foil primary TABLE package containing one-step 1 lengths may be supplied in a RELAY* suture delivery system tray multistrand labyrinth packet or Coated VICRYL* RAPIDE Tyvek ® overwrap, foil primary package, MOST in a folder packet, both of which (polyglactin 910) suture paper folder COMMON are designed to deliver one strand MONOCRYL* Peelable foil overwrap, one-step ETHICON at a time. SUTUPAK sutures (poliglecaprone 25) suture RELAY tray SUTURE may be removed from the packet Coated VICRYL* Plus Peelable foil overwrap, one-step PACKAGING (polyglactin 910) suture RELAY tray and placed in the suture book. Coated VICRYL* Peelable foil overwrap, one-step 3. One single strand of material (polyglactin 910) suture RELAY tray with single- or double-armed PDS* II Peelable foil overwrap, one-step (polydioxanone) suture RELAY tray swaged needle(s). Needles for one-step RELAY suture packets, NONABSORBABLE SUTURE LAYERS micro-surgery, and some PERMA-HAND* Silk Suture Tyvek ® overwrap, one-step RELAY tray ophthalmic needles are secured in Stainless Steel Suture Tyvek ® overwrap, paper folder a "needle park." The needle park ETHILON* nylon suture Peelable foil overwrap, one-step is designed to provide a standard RELAY tray location for, and easy access to, NUROLON* nylon suture Tyvek ® overwrap, one-step RELAY tray the needle. All other needles are MERSILENE* Tyvek ® overwrap, one-step RELAY tray protected within an inner polyester fiber suture folder or other specific channel ETHIBOND* EXCEL Tyvek ® overwrap, one-step RELAY tray within a paper folder. polyester fiber suture

PROLENE* polypropylene suture Tyvek ® overwrap, one-step RELAY tray Most single strand needled sutures are sealed in convenient PRONOVA* Tyvek ® overwrap, one-step RELAY tray poly (hexafluoropropylene-VDF) suture one-step RELAY delivery Tyvek ® is a registered trademark of E.I. du Pont de Nemours and Company packages. One-step RELAY pack- ages allow the needle to be armed in the needleholder from any angle without touching the FIGURE needle. This increases the safety 2 of handling needles intraopera- tively. If it is preferred to locate METHOD FOR PREPARING the needle by hand, this can be ONE-STEP accomplished with the one-step RELAY RELAY package by pushing up PACKAGE the flap behind the needle park, SUTURES thereby elevating the needle so it can be grasped by hand. 4. Multiple suture strands, either swaged to a single needle or double-armed. This type is appropriate for procedures requiring numerous interrupted sutures of the same type. It saves Arm the needle directly from the one-step RELAY tray and deliver the single suture to the surgeon. valuable operative time by CHAPTER 4 59 enabling the surgeon to use one silk sutures, NUROLON nylon the surgical technique. An suture while the next is being sutures, MERSILENE sutures, abdominal incision 8 to 12 armed—without delay of open- and surgical gut sutures. The inches long might require ing packets or threading needles. safety organizer tray allows for one to three packets to single strand arming and ligate the subcutaneous Multistrand packets are labeled dispensing. The needles are blood vessels. with the symbol MS/ that situated in individually num- denotes multiple strands/number All suture material is packaged bered needle parks and may be of strands of surgical needles per dry with the exception of surgical armed and dispensed with little packet. Multistrand packets may gut and pliabilized ETHILON or no hand-to-needle contact. contain 3 to 10 swaged sutures. sutures. Natural absorbable suture The inner folder for these 5. Ligating material used as either materials are packaged with a products is white. single strand (free or freehand) small amount of sterile fluid, ties, or as continuous ties usually alcohol with water, to All packets containing unwound from a reel or other maintain pliability. They should CONTROL RELEASE* needle device. The length of single therefore be opened over a basin to sutures have multiple strands strand ties is determined by the prevent any solution from spilling (8, 5, 4, 3, or 1) and are depth of the wound. In subcuta- onto the sterile field. designated CR/8, CR/5, CR/4, neous tissue, quarter lengths CR/3, or CR/1. CONTROL (approximately 14 inches) are All needles should be counted RELEASE sutures may be usually long enough for ligating. after packets of swaged sutures ® available in foil or Tyvek Single strand ligating material is are opened, according to overwrap packets for single available in pre-cut lengths or 18, established hospital procedure. strand delivery. The single strand 24, and 30 inch strands. The packets should be retained delivery folder is used for some to facilitate verification of the coated VICRYL* (polyglactin Many surgeons prefer continuous final needle count after the 910) sutures, MONOCRYL* ties. Some prefer LIGAPAK* surgical procedure. (poliglecaprone 25) sutures, ligature, which is supplied on PDS* II (polydioxanone) sutures, disc like plastic radiopaque ETHIBOND* EXCEL polyester dispensing reels that are color E-PACK* sutures, NUROLON* nylon coded by material. The size of PROCEDURE KIT sutures, MERSILENE* polyester the ligature material is indicated sutures, and PERMA-HAND* by the number of holes visible on The E-PACK procedure kit silk sutures. The suture material the side of the reel (e.g., 3 holes= contains numerous sutures and straightens as it is delivered from 3-0 suture). The reel is held in other products for a specific the folder. Each suture may be the palm of the hand as blood procedure, surgeon, or surgical delivered to the surgeon individ- vessels are ligated. Other specialty. The packaging concept ually from the opening packet or surgeons may prefer the ligating saves valuable time in the OR by removed from the folder and material rewound onto a rubber eliminating the need to open and placed in the suture book. The reel, gauze sponge, metal bobbin, coordinate multiple individual inner folder for these products is or other device. suture packages. The E-PACK either red with a black C/R The number of packets of procedure kit is also an effective symbol or white with red ligating material required to tie means of reducing inventory lettering. The safety organizer off subcutaneous vessels levels of individual product tray is used for coated VICRYL (bleeders) will vary with patient codes, and providing a record sutures, MONOCRYL sutures, size and age, the amount of for determining the suture PDS II sutures, ETHIBOND bleeding, the type of operation, costs associated with a given EXCEL sutures, PERMA-HAND the length of the incision, and surgical procedure.

* Trademark 60 PACKAGING

The suture packages are secured The RELAY suture delivery system Gas sterilization uses in an organizer sleeve to facilitate is designed as a "first-in, first-out" ethylene oxide gas. As an environ- sterile transfer to the sterile field. inventory control system. Dispenser mental measure, ETHICON The procedure kit label provides all boxes are rotated, permitting the replaced chlorofluorocarbons the pertinent information regarding oldest sutures to be used first. The (CFCs) with more environmentally the number and types of needles, as expiration date stamped on the friendly compounds in all gas well as sizes and types of suture. outside of each box and every sterilization processes. The Suture quantities are listed on the packet clearly indicates the month combination of ethylene oxide label, making it easy to quickly and year of product expiration. gas concentration, temperature, determine how many needles have humidity, and exposure time must been used and thus simplifying be carefully controlled to ensure needle accountability at the end of SUTURE reliable sterilization. the procedure. The organizer sleeve STERII IZATION WARNING: Surgical sutures are is delivered in a Tyvek® pouch. labeled as disposable, single-use Sutures sterilized by ETHICON are medical devices. Suture products either irradiated with cobalt 60 or manufactured by ETHICON are exposed to ethylene oxide gas. Both EXPIRATION DATE provided in easy-to-use packages processes alter proteins, enzymes, designed to maintain the stability The expiration date of a product is and other cellular components to and sterility of the suture and determined by product stability the extent that microorganisms are needle materials. The component studies. The Food and Drug unable to survive or cause infection. layers of packaging materials do Administration (FDA) requires Irradiation and ethylene oxide gas not permit exposure to high that all synthetic absorbable suture are considered cold sterilization temperatures or extremes of pres- products have an expiration date processes because radiation sterilizes sure without affecting package and stamped on each dispenser box at room temperature and ethylene product integrity. For this reason, and primary packet to indicate oxide gas sterilizes at much lower all sterile products manufactured the known shelf life of the material, temperatures than other sterilization by ETHICON are clearly labeled, provided the physical integrity methods such as dry heat or steam "DO NOT RESTERILIZE." of the package is maintained. under pressure. Tests conducted by ETHICON* Manufacturers cannot be held Irradiation sterilization exposes show conclusively that synthetic responsible for the quality, products to ionizing radiation— absorbable suture products such effectiveness, or integrity of either beta rays produced by high as Coated VICRYL* suture and suture materials resterilized in energy electron accelerators or PDS* II suture continue to meet the hospital, office, or by outside gamma rays from radioisotopes— all product requirements even at vendors. Therefore, if customers until absorbed in appropriate five years of storage. utilize the services of a sterilization sterilizing dose. ETHICON was reprocessor for suture, ETHICON In addition, all ETHICON a pioneer in both beta and will disclaim any responsibility for nonabsorbable suture products gamma irradiation and routinely sterilization and/or other product contain a five-year expiry dating sterilizes products with cobalt failures resulting from the resteril- on each dispenser box and 60 which emits gamma rays. ization process. The practice of primary packet. This expiry Cobalt 60 irradiation is the simplest resterilization is not recommended, dating is necessary to comply of all sterilization processes. except for ETHI-PACK* pre-cut with various international Some suture materials cannot steel sutures and spools or cardreels regulatory guidelines and is an aid withstand the effects of irradiation of nonabsorbable materials in inventory management. sterilization, becoming unusable. supplied nonsterile. Instead, they are gas sterilized. CHAPTER 4 61

ANTICIPATING 2. Opening sufficient suture packets 3. Nonsterile hands over the sterile SUTURE NEEDS to prevent prolonging operative field violate aseptic technique. time and causing surgeon There are two methods commonly Today's healthcare environment inconvenience. used for achieving sterile transfer dictates that hospitals continue to 3. Leftover suture on the surgical of suture packets: handing-off the maintain quality standards while field must be discarded. sterile inner one-step RELAY tray lowering costs to remain financially Therefore, opening too many directly to the scrub person or viable. Through total quality man- suture packets should be "flipping" the inner contents of the agement initiatives, many hospitals avoided to reduce waste and to primary packet onto the sterile field. have identified material use as an lower cost. Regardless of the aseptic technique opportunity to lower cost. To performed, all items introduced increase the efficiency of suture Although it is important to be onto the sterile field should be utilization during a surgical prepared to answer requests at a opened, dispensed, and transferred procedure, it is important to moment's notice, it is not necessary by methods that maintain product determine and anticipate the to overload the table with sutures. sterility and integrity. AORN surgeon's needs more precisely. The introduction of single-layer Guidelines recommend the For this reason, a file system of peelable packaging, such as one-step “hand-off” method, since items preference cards for each surgeon RELAY* packaging, helps encourage tossed or flipped have a greater on staff is usually maintained in the less handling to access the suture, potential to roll off the edge of the operating suite. The cards contain enhancing quick delivery of suture sterile field, causing contamination such information as the surgeon's materials to the surgeon in the or other items to be displaced. "suture routine," suture materials, sterile field. Unexpected suture sizes, needles, and/or product needs can also be obtained rapidly from the storage racks. METHOD I: STERILE TRANSFER TO code numbers customarily used in THE SCRUB PERSON specific procedures. STERILE TRANSFER OF Grasp the two flaps of the peelable Becoming more aware of each SUTURE PACKETS overwrap between the knuckles of the thumbs and forefingers. With surgeon's routine through good At some point, suture packets a rolling-outward motion, peel communication and regularly must cross the sterile barrier—the the flaps apart to approximately updated preference cards can help invisible line of demarcation one- third of the way down the reduce preparation time, minimize between the sterile and the nonster- sealed edges. Keeping pressure waste, and assure cost effectiveness. ile. In all settings (e.g., operating between the knuckles for control, Prior to dispensing suture packets, room, delivery room, emergency offer the sterile inner packet or the circulating nurse should have a department, or physician's office), tray to the scrub person, who takes brief discussion with the surgeon to the individual who removes it with a gloved hand or sterile ascertain whether a change in suture the nonsterile overwrap must instrument. Care must be taken to routine is anticipated due to a remember these three points about avoid contact with the nonsterile specific patient's needs. sterile transfer: overwrap as the packet or tray While it is difficult to say precisely 1. Outer surfaces of the overwrap is withdrawn. how many suture packets are are not sterile and may be enough, three major factors should handled with nonsterile hands. This method must be used to remove paper folder packets of sur- be considered in deciding how 2. The sterile inner packet or tray gical steel and PROLENE* sutures many packets to open: must be transferred to the sterile from long straight overwraps, and to 1. Fewer packets will be needed if field without being touched or remove the organizer sleeves from products with multiple strands of contacting any nonsterile object E-PACK* procedure kits. It should suture material are used. or surface. also be used for transfer of flexible,

* Trademark 62 PACKAGING

PREPARATION OF STANDARD LENGTH FIGURE LIGATURE STRANDS 3 FIGURE 4

STERILE TRANSFER TO THE SCRUB PERSON 1. Prepare cut lengths of ligature material, coil around fingers of left hand, grasp free ends with right hand, and unwind to full length.

lightweight, transparent packets Instead, present them to the scrub 2. Maintain loop in left hand and two free ends in right hand. Gently pull containing microsurgery and oph- person as outlined in Method I. the strand to straighten. thalmic products. SUTURE PREPARATION METHOD II: STERILE TRANSFER IN THE STERILE FIELD TO THE STERILE FIELD Suture preparation may be more "Flipping" is a rapid and efficient confusing than virtually any other method of ejecting sterile product aspect of case preparation.

from its overwrap onto the sterile Familiarity and understanding of 3. To make 1/3 lengths: Pass one free field without contacting the the sequence in which tissue layers end of strand from right to left hand. Simultaneously catch a loop around unsterile outer packet or reaching are handled by the surgeon will help third finger of right hand. Make over the field. However, skill must to eliminate this confusion. (See the strands equal in thirds and cut the loops with scissors. be acquired to ensure its effective Suturing Section, Chapter 2.) use. The circulating nurse must stand near enough to the sterile Once the suture packets are opened table to project the suture packet and prepared according to the or tray onto it, but not too close surgeon's preference card, sutures as to risk contaminating the table can be organized in the sequence in by touching it or extending which the surgeon will use them. Ligatures (ties) are often used first 4. To make 1/4 lengths: Pass both free nonsterile hands over it. To ends from right to left hand. accomplish this, grasp the flaps in subcutaneous tissue shortly after Simultaneously catch a double loop the incision is made, unless ligating around third finger of right hand. of the overwrap as described in Cut the loops. Method I and peel the flaps apart clips or an electrosurgical cautery with the same rolling-outward device is used to coagulate severed motion. The sterile packet or tray blood vessels. is projected onto the sterile table After the ligating materials have as the overwrap is completely been prepared, the suturing peeled apart. (sewing) materials can be prepared NOTE: DO NOT attempt to proj- 5. Place packets or strands in suture in the same manner. Preparing large book (folded towel)—or under Mayo ect the inner folder of long straight amounts of suture material in tray—with ends extended far packets onto the sterile table. enough to permit rapid extraction. CHAPTER 4 63

PREPARATION OF CONTINUOUS TIES ON A LIGAPAK DISPENSING REEL FIGURE 5

1. Open the packet contain- 2. Extend the strand end 3. Hand reel to surgeon as 4. Surgeon holds reel in ing the appropriate slightly for easy grasp- needed, being certain that palm, feeds strand material on a reel. Transfer ing. Place reel conviently the end of the ligating beween fingers, and the inner contents of the on the Mayo tray. material is free to grasp. places around tip of primary packet to the hemostat. sterile field using aseptic technique.

FIGURE 6

PEPARATION OF PRE-CUT SUTURES FOR TIES OR LIGATURE SUTURES

1. Remove one pre-cut length from nonabsorbable 2. Extract pre-cut strands of SUTUPAK* sterile suture at a time from the labrinth packet as it is absorbable or nonabsorbable suture. Straighten needed by the surgeon. surgical gut with a gentle pull. Place strands in the suture book or under Mayo tray. advance should be avoided. For be used to prepare sufficient suture are shorter than those prepared example, if the surgeon opens the material to stay one step ahead of originally, do not be reluctant to peritoneum (the lining of the the surgeon. The goal should be to ask the surgeon if one of the abdominal cavity) and discovers have no unused strands at the end strands will serve the purpose disease or a condition that alters of the procedure. before opening a new packet. plans for the surgical procedure Most surgeons are cooperative in Ligature material which remains and anticipated use of sutures, efforts to conserve valuable supplies. toward the end of the procedure opened packets would be wasted. may be the same material and size At closure following abdominal SUTURE HANDLING specified by the surgeon for sutures surgery, remembering the letters TECHNIQUE in the subcutaneous layer of wound PFS (peritoneum, fascia, skin) will During the first postoperative week, closure. In this case, the remaining be helpful for organizing sutures. the patient's wound has little or no ligating material should be used strength. The sutures or mechanical By watching the progress of the rather than opening an additional devices must bear the responsibility procedure closely, listening to suture packet. of holding the tissues together comments between the surgeon If the surgeon requires "only during this period. They can only and assistants, and evaluating one more suture," and strands of perform this function reliably if the the situation; suture needs can suitable material remain which quality and integrity of the wound be anticipated. Free moments can * Trademark 64 PACKAGING

closure materials are preserved FOR THE CIRCULATING NURSE by projecting (flipping) it onto during handling and preparation 1. Consult the surgeon's preference the sterile table, avoiding prior to use. It is therefore essential card for suture routine. contamination. for everyone who will handle the 2. Check the label on the dispenser 6. To open long straight packets, suture materials to understand box for type and size of suture peel overwrap down 6 to 8 inch- proper procedure to preserve material and needle(s). Note the es and present to the scrub suture tensile strength. number of strands per packet. person. Do not attempt to In general, avoid crushing or Fewer packets will be needed if project the inner folder of long crimping sutures with surgical multistrand or CONTROL straight packets onto the instruments such as needleholders RELEASE* sutures are used. sterile table. and forceps, except as necessary 3. Estimate suture requirements 7. Maintain an adequate supply of to grasp the free end of a suture accurately and dispense only the the most frequently used sutures during an instrument tie. There type and number of sutures readily accessible. are also specific procedures to required for the procedure. 8. Rotate stock using the "first-in, follow to preserve suture tensile 4. Read the label on the primary first-out" rule to avoid expira- strength which depend upon packet or overwrap before using tion of dated products and keep whether the material is absorbable to avoid opening the wrong inventories current. or nonabsorbable. The following packet. 9. Suture packets identify the summarizes the most important number of needles per packet to points for each member of the 5. Use aseptic technique when simplify needle counts. Retain surgical team to remember and peeling the overwrap. Transfer this information during the observe in handling suture materials the inner contents of the primary procedure and/or until final and surgical needles. packet to the sterile field by offering it to the scrub person or needle counts are completed. 10. Count needles with the scrub person, per hospital procedure. FIGURE 7 FOR THE SCRUB PERSON 1. If appropriate, remove the inner ETHICON one-step RELAY* tray or folder MODULAR containing suture materials from STORAGE RACKS the primary packet being offered from the circulating nurse. 1. With a rolling-outward motion, 2. Clamp the needleholder approx- 2. Hold the one-step RELAY tray or peel the flaps apart to approxi- imately one-third to one-half of mately ont-third the way down the distance from the swage folder in gloved hand and arm the sealed edges. Keeping pres- area to the needle point. Do not the needle using the "no-touch" sure beween the knuckles for clamp the swaged area. Gently control, offer the sterile inner pull the suture to the right in a technique. Gently dispense the RELAY tray to the scrub person. straight line. suture.

3. Additional suture straightening 3. Leave pre-cut suture lengths in should be minimal. If the strand labyrinth packet on the Mayo must be straightened, hold the armed needleholder and gently tray. Strands can then be pull the strand making certain removed one at a time as needed. not to disarm the needle from the suture. 4. Surgical gut and collagen sutures for ophthalmic use must first be rinsed briefly in tepid water to avoid irritating sensitive tissues. CHAPTER 4 65

If the surgeon prefers to use on strands can crush, cut, and sutures wet, dip only momentar- weaken them. ily. Do not soak. Silk sutures 12. Cut sutures only with suture should be used dry. scissors. Cut surgical steel with 5. Do not pull or stretch surgical wire scissors. gut or collagen. Excessive 13. When requesting additional handling with rubber gloves can suture material from the weaken and fray these sutures. circulating nurse, estimate usage 6. Count needles with the as accurately as possible to circulating nurse, per hospital avoid waste. procedure. FOR THE SURGEON 7. Hold single strands taut for surgeon to grasp and use as a 1. Avoid damage to the suture freehand tie. strand when handling. This is particularly critical when 8. Do not pull on needles to handling fine sizes of monofila- straighten as this may cause ment material. Touch strands premature separation of only with gloved hand or closed CONTROL RELEASE needle blunt instrument. Do not crush suture. or crimp sutures with instru- 9. Always protect the needle to ments, such as needleholders or prevent dulling points and forceps, except when grasping the cutting edges. Clamp the needle- free end of the suture during an holder forward of the swaged instrument tie. area, approximately one-third to 2. Clamp a rubber shod hemostat one-half the distance from the onto the suture to anchor the swage to the point. free needle on a double-armed 10. Microsurgery sutures and strand until the second needle is needles are so fine that they may used. Never clamp the portion of be difficult to see and handle. suture that will be incorporated They are packaged with the into the closure or the knot. needles parked in foam to 3. Use a closed needleholder or protect delicate points and nerve hook to distribute tension edges. The needles may be along a continuous suture line. armed directly from the foam Be careful not to damage the needle park. If the microsurgeon suture. prefers to arm the needle, the removable orange colored tab 4. Use knot tying techniques that may be used to transport the are appropriate for the suture needle into the microscopic material being used. field. 11. Handle all sutures and needles as little as possible. Sutures should be handled without using instruments unless absolutely necessary. Clamping instruments

* Trademark 66 PACKAGING

1. Protect absorbable sutures from heat and moisture. a. Store suture packets at room temperature. Avoid prolonged storage in hot TABLE areas such as near steam pipes or sterilizers. 2 b. Do not soak absorbable sutures. Also avoid prolonged placement of sutures in a moist suture book. PRESERVATION c. Surgical gut can be dipped momentarily in tepid (room temperature) water OF TENSILE or saline to restore pliability if strands dry out before use. Surgical gut or STRENGTH: collagen for use in ophthalmic surgery should be rinsed briefly in tepid ABSORBABLE water before use, as they are packed in a solution usually consisting of SUTURES alcohol and water to maintain pliability. d. Synthetic absorbable sutures must be kept dry. Use strands directly from packet when possible. Store sutures in a dry suture book if necessary. 2. Straighten strands with a gently, steady, even pull. Jerking and tugging can weaken sutures. 3. Do not "test" suture strength. 4. Do not resterilize.

SILK – Store strands in a dry towel. Dry strands are stronger than wet strands. Wet silk loses up to 20% in strength. Handle carefully to avoid abrasion, kinking, nicking, or TABLE instrument damage. Do not resterilize. 3

SURGICAL STAINLESS STEEL – Handle carefully to avoid kinks and bends. Repeated PRESERVATION bending can cause breakage. Stainless steel suture can be steam sterilized without any OF TENSILE loss of tensile strength. However, DO NOT steam sterilize on spool or in contact with STRENGTH: wood. Lignin is leached from wood subjected to high temperature and may cling to NONABSORBABLE suture material. Handle carefully to avoid abrasion, kinking, nicking, or instrument dam- SUTURES age.

POLYESTER FIBER – Unaffected by moisture. May be used wet or dry. Handle carefully to avoid abrasion, kinking, nicking, or instrument damage. Do not resterilize.

NYLON – Straighten kinks or bends by "caressing" strand between gloved fingers a few times. Handle carefully to avoid abrasion, kinking, nicking, or instrument damage.

POLYPROPYLENE – Unaffected by moisture. May be used wet or dry. Straighten strands with a gentle, steady, even pull. Handle with special care to avoid abrasion, kinking, nicking, or instrument damage. Do not resterilize. CHAPTER 5

TOPICAL SKIN ADHESIVES 68 TOPICAL SKIN ADHESIVES

Low tension wounds (those where It utilizes the moisture on the skin's ProPen XL adhesive delivers twice as the skin edges lie close together surface to form a strong, flexible much adhesive for use on longer without significant tension) can be bond and can be used in many incisions and lacerations. closed by gluing the skin edges instances where sutures, staples or together with a skin adhesive. skin strips have been traditionally STRENGTH AND SECURITY Butylcyanoacrylate adhesives have used. DERMABOND adhesive is In less than three minutes, been available in Europe, Israel, and ideally suited for wounds on the DERMABOND adhesive provides Canada for decades.1 They have face, torso and limbs. It can be used the strength of healed tissue at been used successfully for the in conjunction with, but not in 7 days.2 A strong, flexible closure of traumatic lacerations and place of, deep dermal sutures. 3-dimensional bond makes it surgical incisions. Application of suitable for use in closing easily Approved by the FDA in 1998, butylcyanoacrylate was found to be approximated incisions of many DERMABOND adhesive has more rapid and cost effective than types (example—deep, short, long).3 been used extensively by health suturing, but only recently has it professionals in the fields of been evaluated in well-designed SEALS OUT BACTERIA trauma and other surgeries, clinical trials for wound closure.1 DERMABOND adhesive is emergency medicine, and pediatrics. The most significant advance in approved to protect wounds and Since its approval, DERMABOND the field of topical skin adhesives incisions from common microbes that adhesive has been proven effective has been the development of can lead to infection. For trauma and in closing a variety of surgical 2-octyl cyanoacrylate, marketed as post-surgical patients, infections are incisions and wounds. Unlike DERMABOND* Topical Skin often the most common, and in sutures, the adhesive does not pro- Adhesive by ETHICON Products. some cases, the most serious duce suture or "track" marks along This topical skin adhesive forms a complications. DERMABOND the healed incision and a patient transparent and flexible bond, adhesive helps protect against the can shower right away without fear unlike the opaque and brittle bond penetration of bacteria commonly of compromising the incision. formed by butylcyanoacrylate associated with surgical site adhesives. The flexibility of infections.2 In vitro studies HIGH VISCOSITY octyl cyanoacrylate allows it to be demonstrated that DERMABOND DERMABOND* applied over nonuniform surfaces. acts as a barrier against TOPICAL SKIN ADHESIVE This flexibility also combats the Staphylococcus epidermidis, (2-OCTYL CYANOACRYLATE) topical shear forces exerted on the Staphylococcus aureus, Escherichia High Viscosity DERMABOND adhesive, reducing the risk of coli, Pseudomonas aeruginosa and adhesive is 6 times thicker 2 for premature sloughing and wound Enterococcus faecium as long as the better control, especially where dehiscence. Additionally, octyl adhesive film remains intact.2 runoff is most likely to occur, such cyanoacrylate adhesive has been as around the eyes and nose. found to have three times the PROMOTES A MOIST, breaking strength of butylcyano- Dome-, Precision-Tip and NEW WOUND HEALING ENVIRONMENT acrylate, so it can be used on longer DERMABOND ProPen adhesive DERMABOND adhesive creates a incisions and lacerations.1 applicators allow for fine-line deliv- protective seal and is an occlusive ery of adhesive2 – ideal for delicate dressing that helps the wound stay DERMABOND* skin closures on the face and near moist.2 Maintaining a moist wound TOPICAL SKIN ADHESIVE the eyes. healing environment around the (2-OCTYL CYANOACRYLATE) wound has been shown to speed the New DERMABOND ProPen 4 is a sterile, liquid topical adhesive rate of epithelialization. As the adhesive and DERMABOND designed to hold closed, easily wound heals, DERMABOND ProPen XL adhesive deliver the high approximated skin edges of adhesive will gradually slough off viscosity formulation with greater 2 lacerations and surgical incisions. (generally between 5 to 10 days). ease of use. DERMABOND CHAPTER 5 69

dynamic tensions unless deep PROVIDES EXCELLENT sutures, immobilization, or both TECHNIQUE COSMETIC RESULTS are also used. 1.Follow standard surgical practice In a prospective, randomized, for wound preparation and DERMABOND adhesive is controlled, unmasked study of 818 achieve hemostasis. contraindicated for use on any patients, DERMABOND adhesive 2.Approximate skin edges and use provided cosmesis equivalent to that wounds with evidence of active infection or gangrene. It should also deep sutures to relieve of sutures. At 3 months, it produced tension if necessary. optimal cosmesis in 80% of not be used on mucosal surfaces or patients, using the Modified across mucocutaneous junctions 3.Crack the DERMABOND Hollander Cosmesis Scale.2 (e.g., lips, oral cavity), or on skin adhesive vial in the upright that is regularly exposed to position, invert, and apply ADDITIONAL PHYSICIAN AND body fluids or with dense hair pressure to saturate the tip. PATIENT BENEFITS (e.g., scalp). DERMABOND adhe- Release pressure, then reapply In most cases, DERMABOND sive should not be used on patients pressure to express adhesive. adhesive allows for significantly with a known hypersensitivity to When using the NEW faster closure than sutures.3,5,6 cyanoacrylate or formaldehyde. DERMABOND ProPen adhesive DERMABOND adhesive applicator, simply twist the collar application requires fewer surgical APPLICATION to crack the vial and lightly press supplies, reduced equipment Mastery of tissue adhesive use the button to saturate the tip and needs, and eliminates the need for is generally quite rapid. Proper express the adhesive. suture removal.6,7 wound selection, evaluation and 4.Apply 2 thin layers of adhesive, preparation before closure is waiting approximately 30 seconds DERMABOND adhesive is also important. Wounds must be between layers (NOTE: 3 layers more convenient and comfortable thoroughly cleansed and debrided of adhesive are required when for the patient because it often in accordance with standard practice using original DERMABOND does not require anesthetic, is before using adhesives. The wound adhesive.) gentler to the skin than sutures or edges must be tightly apposed so staples, and does not require suture that the adhesive is not placed DIRECTIONS FOR USE removal. DERMABOND adhesive into the wound. Patient positioning 1. The application of high viscosity also reduces the risk of needle is also important to reduce runoff DERMABOND adhesive requires stick injury. of tissue adhesive. The patient thorough wound cleansing. Follow standard surgical practice for wound should be positioned so that the INDICATIONS AND preparation before application of high wound surface is parallel to the CONTRAINDICATIONS viscosity DERMABOND adhesive floor, taking special care that (i.e., anesthetize, irrigate, debride, obtain DERMABOND adhesive is intended any runoff does not flow in the hemostasis and close deep layers). for topical application only to hold direction of vital structures such 2. Pat the wound dry with dry, sterile gauze closed easily approximated skin edges to assure direct tissue contact for as the eye. of wounds from surgical incisions, adherence of the high viscosity including punctures from minimally DERMABOND adhesive to the skin. Moisture accelerates high viscosity invasive surgery, and simple, DERMABOND adhesive’s thoroughly cleansed, trauma-induced polymerization and may affect lacerations. DERMABOND adhesive wound closure results. may be used in conjunction with, but 3. To prevent inadvertent flow of liquid not in place of, deep dermal sutures. high viscosity DERMABOND adhesive to unintended areas of the body, the Topical skin adhesives are not wound should be held in a horizontal appropriate for closing wounds that position and the high viscosity are subject to significant static or DERMABOND adhesive should be

* Trademark 70 TOPICAL SKIN ADHESIVES applied from above the wound.

HOW TO CARE FOR A WOUND AFTER IT’S TREATED WITH DERMABOND* TOPICAL SKIN ADHESIVE TABLE 1 DERMABOND Topical Skin Adhesive (2-octyl AVOID TOPICAL MEDICATIONS cyanoacrylate) is a sterile, liquid skin adhesive that Instruct patients not to apply liquid or ointment holds wound edges together. The film will usually medications or any other product to the wound while remain in place for 5 to 10 days, then naturally falls the DERMABOND adhesive film is in place. These off the skin. may loosen the film before the wound is healed.

The following provides instructions for proper care of KEEP WOUND DRY AND PROTECTED the wound while it is healing: Patients may occasionally and briefly wet the wound in the shower or bath. They should not soak or scrub CHECK WOUND APPEARANCE the wound. They should not swim and should Some swelling, redness and pain are common with all avoid periods of heavy perspiration until the wounds and normally will go away as the wound DERMABOND adhesive has naturally fallen off. heals. If swelling, redness, or pain increases or if the After showering or bathing, the patient should blot wound feels warm to the touch, instruct patients to the wound dry with a soft towel. If a protective contact a doctor. A doctor should also be contacted if dressing is being used, a fresh, dry bandage should the wound edges reopen or separate. be applied, being sure to keep the tape off the DERMABOND adhesive film. REPLACE BANDAGES If the wound is bandaged, the patient should be Additional instructions for patients include: instructed to keep the bandage dry. The dressing should be replaced daily until the adhesive film has • Apply a clean, dry bandage over the wound if fallen off or if the bandage should become wet, unless necessary to protect it. otherwise instructed by the physician. • Protect the wound from injury until the skin has When changing the dressing, tape should not be had sufficient time to heal. placed directly over the DERMABOND adhesive • Do not scratch, rub or pick at the DERMABOND film, because removing the tape later may also adhesive film. This may loosen the film before the remove the film. wound is healed. • Protect the wound from prolonged exposure to sunlight or tanning lamps while the film is in place. CHAPTER 5 71

4. High viscosity DERMABOND adhesive NOTE: Full apposition strength is should be only transient wetting of the hould be used immediately after expected to be achieved about treatment site. Patients may shower and crushing the glass ampule, since the 2.5 minutes after the final layer is bathe the site gently. The site should not liquid high viscosity DERMABOND applied, although the top adhesive be scrubbed, soaked, or exposed to adhesive will flow freely from the tip for layer may remain tacky for up to prolonged wetness until after the film only a few minutes. Remove the approximately 5 minutes. Full has sloughed naturally and the wound applicator from the blister pouch. polymerization is expected when the top has healed closed. Patients should be Hold the applicator with the thumb and high viscosity DERMABOND adhesive instructed not to go swimming during finger and away from the patient to layer is no longer sticky. this period. prevent any unintentional placement 6. Do not apply liquid or ointment 12. If removal of high viscosity of the liquid high viscosity medications onto wounds closed with DERMABOND adhesive is necessary DERMABOND adhesive into the high viscosity DERMABOND adhesive for any reason, carefully apply petroleum wound or on the patient. While holding because these substances can weaken the jelly or acetone to the high viscosity the applicator, and with the applicator polymerized film, leading to wound DERMABOND film to help loosen the tip pointed upward, apply pressure at dehiscence. bond. Peel off the film, do not pull the the midpoint of the ampule to crush the 7. Protective dry dressing such as gauze, skin apart. inner glass ampule. Invert and gently may be applied only after high viscosity squeeze the applicator just sufficiently to DERMABOND adhesive film is express the liquid high viscosity completely solid/polymerized: not tacky REFERENCES DERMABOND adhesive to moisten to the touch (approximately five minutes 1. Singer, Adam J., Lacerations and the applicator. after application). Allow the top layer to Acute Wounds, An Evidence- 5. Approximate wound edges with gloved fully polymerize before applying Based Guide; F.A. Davis fingers or sterile forceps. Slowly a bandage. Company, 2003, p. 83-97. apply the liquid high viscosity If a dressing, bandage, adhesive backing DERMABOND adhesive in multiple 2. Data on file, ETHICON, INC. or tape is applied before complete 3. Quinn, G Wells, T Sutcliffe, (at least 3) thin layers to the surface of polymerization, the dressing can adhere et al. A Randomized Trial the approximated wound edges using a to the film. The film can be disrupted gentle brushing motion. Wait from the skin when the dressing is Comparing Octyl Cyanoacrylate approximately 30 seconds between removed, and wound dehiscence Tissue Adhesive and Sutures in applications or layers. Maintain manual can occur. the Management of Lacerations. approximation of the wound edges for 8. Patients should be instructed to not pick JAMA 1997;227(19):1527-1530. approximately 60 seconds after the at the polymerized film of high viscosity 4. Singer AJ, Hollander JE, Quinn final layer. DERMABOND adhesive. Picking at JV. Evaluation and management NOTE: High viscosity DERMABOND the film can disrupt its adhesion to the of traumatic lacerations. adhesive polymerizes through an skin and cause dehiscence of the wound. N Engl J Med. exothermic reaction. If the liquid high Picking at the film can be discouraged 1997;337(16):1142-1148. viscosity DERMABOND adhesive is by an overlying dressing. 5. Bruns TB, Robinson BS, Smith applied so that large droplets are allowed 9. Apply a dry protective dressing for to remain without being evenly spread, children or other patients who may not RJ et al. A new tissue adhesive the patient may experience a sensation be able to follow instructions for proper for laceration repair in children. of heat or discomfort. The sensation wound care. J Pediatr. 1998;132:1067-1070. may be higher on sensitive tissues. This 10. Patients treated with high viscosity 6. Theodore N, et al. The can be minimized by applying high DERMABOND adhesive should be Economics of DERMABOND viscosity DERMABOND adhesive in provided the printed instruction sheet in Neurosurgical Wound multiple thin layers (at least 3). entitled, How to Care for Your Wound Closure. Phoenix, Ariz: NOTE: Excessive pressure of the After It’s Treated With high viscosity Neuroscience Publications, applicator tip against the wound edges DERMABOND Topical Skin Adhesive. Barrow Neurological Institute. This instruction sheet should be or surrounding skin can result in forcing March 2001:2-10. the wound edges apart and allowing reviewed with each patient or guardian to assure understanding of the proper 7. Osmond MH, Klassen TP, high viscosity DERMABOND adhesive Quinn JV. Economic comparison into the wound. High viscosity care for the treatment site. of a tissue adhesive and suturing DERMABOND adhesive withing 11. Patients should be instructed that until the wound could delay wound the polymerized film of high viscosity in the repair of pediatric facial healing and/or result in adverse DERMABOND adhesive has sloughed lacerations. J Pediatr. 1995; cosmetic outcome. naturally (usually in 5-10 days), there 126:892-895.

* Trademark CHAPTER 6

OTHER SURGICAL PRODUCTS 74 OTHER SURGICAL PRODUCTS

ADHESIVE TAPES dislodgement and dehiscence, wound edge is then gently apposed the inability to use them in by pushing with a finger of the There are many surgical products hair-bearing areas, and the need nondominant hand. The wound available which may be used during to keep them dry. Their use is edges should not be apposed by wound closure and other operative typically reserved for linear lacera- pulling on the free end of the procedures which involve suturing. tions under minimal tension. tape. This can result in unequal Each of these products has specific Furthermore, surgical tapes do not distribution of skin tensions, indications for use. Adhesive tapes approximate deeper tissues and do causing erythema or even blistering are used for approximating the not control bleeding. of the skin. Additional strips are edges of lacerations, skin closures, then placed perpendicular to the repair and/or support in selected INDICATIONS AND USAGE laceration on either side of the operative procedures. Skin closure tapes are an effective original tape, bisecting the Adhesive tapes are associated with alternative to sutures or staples remaining open wound with each minimal tissue reactivity and yield when tensile strength and resistance strip until the space between tapes the lowest rate of infection, but to infection are not critical factors. is no more than about 2 to 5 mm. they tend to slough off in the Skin closure tapes can also be Additional strips are then placed presence of tension or moisture.1 used to complement suture or over the ends of the other strips, Advantages of adhesive tapes staple closures. Stress is applied parallel to the laceration. uniformly to the collagen fibers, include rapid application, little or Skin closure tapes may also be used aiding in rapid fiber orientation no patient discomfort, low cost, and as a replacement for sutures or and increased tensile strength. no risk of needle-stick injuries. They staples which are removed on the are associated with minimal tissue first to fourth postoperative day. APPLICATION reactivity and yield the lowest infec- Effective skin closure tapes provide Skin closure tapes may be applied to tion rates of any wound closure good porosity in terms of air inflow the skin over a subcuticular closure method. They may be left on for to the wound and water vapor in lieu of skin sutures or used as a long periods without resulting in transmission escaping from the primary closure in conjunction with suture hatch marks. wound during the healing process. sutures in an alternating pattern. Surgical tapes are not commonly The tape is placed on one side of AFTER CARE AND REMOVAL recommended as the sole modality the wound at its midpoint, while Adhesive tapes should be left in for primary wound closure due grasping it with forceps in the place as long as possible, at least as to the high probability of dominant hand. The opposite long as sutures would be left before removal. To prevent the tapes from prematurely coming loose, patients ADVANTAGES DISADVANTAGES must be warned to keep them as TABLE dry as possible and not to cover • Rapid and simple • Relatively poor 1 closure adherence them with ointments. Showering is permitted and during the ADVANTAGES • Least damage to • Easily removed by first week many surgeons host defenses patient AND DISADVANTAGES recommend that patients cover • No risk of needle-stick • Must be kept dry OF ADHESIVE their wounds and tape with a injuries • Cannot be used over TAPES FOR nonadherent dressing. 1 • Do not cause tissue oily or hair-bearing SKIN CLOSURE ischemia or necrosis areas CHAPTER 6 75

material for orthopaedic procedures such as rotator cuff repair and FIGURE 1 support. The blunt needles used for the incompetent cervix ligation may SKIN also be used for this purpose. CLOSURE TAPES UMBILICAL TAPE Umbilical tape is a white woven 1 1 1. Using sterile technique, 2. Peel off tapes as needed in cotton ligature, /8 or /4 inch remove card from sleeve and diagonal direction. (0.32 or 0.64cm) wide that is strong tear off tab. enough to tie off the umbilical cord of the newborn infant. While this was its original use, umbilical tape is also used in pediatric and cardiovascular procedures to suspend small structures and vessels during the operation, but is not left in place. Umbilical tape easily absorbs 3. Apply tapes at 1/8-inch 4. When healing is judged to be blood when used in an area of adequate, remove each tape intervals as needed to 1 complete wound apposition. by peeling off each half from gross bleeding. The /8-inch Make sure the skin surface is the outside toward the wound (0.32cm) tape is available with a dry before applying each tape. margin. Then, gently lift the tape away from the radiopaque thread woven into the wound surface. length of the fabric to facilitate x-ray identification. SKIN CLOSURE TAPES available with and without needles and may be used instead PROXI-STRIP* skin closures are of large-sized suture for ligation, long, narrow, sterile strips of tape repair, and/or support in selected with an adhesive backing. They are SURGICAL operative procedures. used for approximating the edges of STAPLES lacerations and for closing skin fol- Incompetence of the cervix is a The staple closure is mainly used for lowing many operative procedures. condition characterized by the large wounds that are not on the habitual premature, spontaneous PROXI-STRIP skin closures have a face. Stapling is especially useful abortion of the fetus. A ligature is high degree of porosity to allow the for closing scalp wounds. Staples placed around the cervix in a wound to breathe, but have suffi- are also used for linear lacerations collar-like fashion, drawn tight, cient adhesive strength to negate the of the torso and extremities, and either sutured together or tied use of adjunct applications, such as especially if they are relatively long. closed. A MERSILENE strip is tincture of benzoin. Their antistatic Many surgeons routinely use skin then woven carefully with a swage properties minimize the tendency of staples for closure of standard blunt needle in and out of the the tape strips to curl up. abdominal, thorax and extremity mucosa. When placed properly, incisions. Advantages of stapling the flatness of the ligature will not POLYESTER FIBER STRIP include ease of use, rapidity, cost cut or damage the wall of the cervix. MERSILENE* polyester fiber strip effectiveness, and minimal damage is comprised of a double thickness MERSILENE strip attached to to host defenses.1 of MERSILENE polyester fiber a heavy reverse cutting needle that is 5mm wide. The strips are provides a wide band of strong

* Trademark 76 OTHER SURGICAL PRODUCTS

A variety of stapling devices is Before inserting staples, it is impor- AFTERCARE AND REMOVAL available for wound closure. With tant to line up the wound edges Skin staples should be removed all devices, the staple creates an with the centerline indicator on the at the same time that sutures incomplete rectangle: the legs of the head of the stapler to make sure that would be removed, based on wound staple extend into the skin, and the the legs of the staple will enter the location and tension. For scalp cross-limb lies on the skin surface skin at equal distances on either side wounds, staples should be removed across the wound. Each device may of the wound edge. Each edge is on day 7 after insertion. For trunk differ in its handling characteristics, typically picked up with a forceps, and extremity wounds, staples visual access, the angle at which everted and precisely lined up. should be removed between days 7 the staples enter tissues, the ease The surgeon then places the staples and 14. Wounds closed with staples of position and the pre-cocking to close the wound while the first may be covered with a topical mechanism. Optimal visibility as assistant advances the forceps, antibiotic cream or ointment. the staple is placed in the skin is everting the edges of the wound. Patients may bathe or shower important, as is the angle at which This technique is continued until the next day, but should avoid the staple enters the skin because the entire wound is everted and prolonged exposure to moisture. insertion of the staple perpendicular closed with staples.2 When used on the scalp, patients to the surface of the skin results in should be very careful about deep penetration that increases the INDICATIONS AND USAGE combing or brushing their hair. likelihood of tissue strangulation Wound closure with staples is A specially designed, single-handed, and permanent cross-hatching of indicated for scalp lacerations disposable staple remover should be the wound. The ability of the that do not require extensive used to remove the staples by a staple end to swivel allows the head hemostasis and do not involve tears health care provider. to be adjusted for use in deep in the underlying frontooccipital recesses. Finally, the presence of a aponeurosis (galea). They are PROXIMATE* Skin Staplers pre-cocking mechanism allows the also indicated for linear nonfacial PROXIMATE Skin Staplers place practitioner to maintain constant lacerations caused by shear forces single staples to close surgical control while stapling the skin.1 (e.g., sharp objects). incisions. Staples are made of lubricant-coated stainless steel;

PROXIMATE* SKIN STAPLERS TABLE 2 PROXIMATE* RH Skin Staplers PROXIMATE* PX Skin Staplers PROXIMATE* PLUS MD Skin Staplers (Rotating Head Skin Staplers) (Multi-Directional Skin Staplers)

Features Benefits Features Benefits Features Benefits

Rectangular Minimizes staple Ergonomic pistol Intuitive and Improved kick-off Multi-direction staples rotation grip comfortable to use spring design release

Head rotates 360°; Improves visibility Positive ratchet Easy staple Ergonomic design Comfortable for cartridge is clear and access mechanism placement smaller hands

Staples are coated Easy staple Staples are coated Easy staple Alignment indicator Improves visibility with lubricant extraction with lubricant extraction

Pistol-grip handle Comfortable Staples are coated Easy staple extraction to use with lubricant CHAPTER 6 77 the staplers are not reloadable. ETHICON Endo-Surgery makes FIGURE three different skins staplers to 1 meet surgeons’ needs. ADJUSTMENT PROXIMATE* PX skin stapler OF provides many of the same features RETENTION as the PROXIMATE RH skin SUTURE BRIDGE stapler but in a fixed-head format. 1. Pass the retention suture 2. Place the suture with tension through appropriate holes in over the slit in the capstan, PROXIMATE* PLUS MD is a the bridge. and tie. high-value, low-cost skin stapler that permits multi-directional release in an ergonomic design.

LOOPED SUTURE ETHICON looped sutures range in length up to a 60-inch strand with both ends swaged to a single taper 3. To adjust tension, lift capstan. 4. Rotate capstan until desired point needle. Available in various tension is attained. materials and suture sizes, they provide a simple, reliable technique for continuous closure of the fascia of the abdominal wall. The needle of the looped suture is passed through the fascia from inside out at one end of the incision, then through the opposite wound edge from outside in, and then passed 5. To lock, press capstan down through the loop. The locking stitch into bridge. lies beneath the wound edge. The double strand is run over and over (0.48cm) diameter surgical latex 1 to the other end of the incision. RETENTION tubing with a /32-inch (0.08cm) The final stitch is completed by SUTURE DEVICES wall. The suture is threaded through passing the needle from the outside the bolster and tied. Sutures in, cutting one strand, and passing Retention sutures, if not placed sheathed in this manner can cause the needle through the opposite carefully without excessive tension, an inflammatory response with wound edge from the outside in. can cut the skin. Devices such as reaction both at the site of the The needle is then cut off and bolsters and bridges are used to suture exit from the skin and along the loose suture ends tied together, prevent such complications and the entire length of the suture itself. leaving the knot inverted under eliminate pressure. However, care Also, the skin may become necrotic the fascia. should also be taken in the use of beneath the bolsters if the sutures these devices. are too tight. This invariably occurs Retention suture bolsters are sterile if the sutures are tightly tied at the time of the operation, as subsequent 2 1/2-inch (6cm) lengths of 3/16-inch tissue edema ensues.

* Trademark 78 OTHER SURGICAL PRODUCTS

The retention suture bridge is a strong plastic truss that can be adjusted to relieve the pressure of the retention suture on the skin during, and subsequent to, initial suture placement. After the desired number of sutures is placed in the wound, a sterile bridge is positioned over each retention suture. Each side of the bridge has six holes spaced 1/4 inch (0.64cm) apart to accommodate many patient sizes. The ends of the sutures are passed through the appropriate holes and tied loosely over the bridge. The suture strand is then slipped into the capstan located in the middle of the bridge, and the capstan is rotated to apply the desired tension before locking into place. The bridge permits easy tension readjustment by raising and rotating the capstan to compensate for postoperative wound edema, and again when the edema subsides. The suture remains elevated away from the skin while the bridge has contact along its entire 4 3/8-inch (11cm) length. Pressure is evenly distributed over the area, and the transparent bridge facilitates com- plete visualization of the wound.

REFERENCES 1. Singer, Adam J., Lacerations and Acute Wounds, An Evidence-Based Guide; F.A. Davis Company, ©2003, p. 64-71, 73-82. 2. Skerris, David A., Mayo Clinic Basic Surgery Skills, Mayo Clinic Scientific Press, 1999; p.117. CHAPTER 7

PRODUCT TERMS AND TRADEMARKS 80 PRODUCT TERMS AND TRADEMARKS

ABSORBABLE SUTURE CHROMIC SURGICAL GUT COMPOUND CURVED NEEDLE Sutures which are broken down and Gut suture which has been treated Needle that incorporates two eventually absorbed by either by chromium salts to resist curvatures in one needle: a tight hydrolysis (synthetic absorbable digestion by lysosomal enzymes. curve at the tip, and a more gradual sutures) or digestion by lysosomal curve through the body. Used for enzymes elicited by white blood CHROMICIZING precise positioning of sutures for cells (surgical gut and collagen). ETHICON process for producing comeal/scleral closure and for chromic gut. Each ribbon of skin suturing. APPROXIMATE surgical gut is bathed in a Bring together sides or edges. chromium salt solution before CONTAMINATE spinning into strands to provide To cause a sterile object or surface ATRALOC* uniform controlled absorption. to become unsterile. SURGICAL NEEDLES ETHICON* trademark for eyeless COATED VICRYL* CONTINUOUS SUTURE needles permanently attached (POLYGLACTIN 910) SUTURE TECHNIQUE (swaged) to suture strands. ETHICON trademark for synthetic Single suture strand passed back and absorbable suture extruded from a forth between the two edges of the B & S GAUGE copolymer of glycolide and lactide wound to close a tissue layer; tied Brown and Sharpe gauge commonly and coated with a mixture of only at each end of the suture line. used in hospitals to identify wire polyglactin 370 and calcium diameter. ETHICON stainless steel stearate. CONTROL RELEASE* NEEDLE suture products are labeled with ETHICON trademark for swaging both B & S gauge and U.S.P. size. COATED VICRYL* Plus method which permits fast and ANTIBACTERIAL controlled separation of the needle BURIED SUTURE (POLYGLACTIN 910) SUTURE from the suture material. Any stitch made and tied so that ETHICON trademark for synthetic it remains completely under absorbable suture extruded from a CONVENTIONAL the surface. copolymer of glycolide and lactide CUTTING NEEDLE (polyglactin 370) and calcium Needle with triangular point and CALCIFIED CORONARY stearate. The first and only suture cutting edge along inner curvature NEEDLE (CC) that protects against bacterial of needle body. A TAPERCUT* surgical needle colonization of the suture. with a 1/16" cutting tip and slim CORNEAL BEADED COATED VICRYL* RAPIDE taper ratio for significant ease of RETRACTION SUTURE (POLYGLACTIN 910) SUTURE penetration when suturing tough Swaged suture strand with a small ETHICON trademark for braided, valve cuffs or atherosclerotic vessels. bead of epoxy used to elevate cornea rapidly absorbing synthetic suture for placement of intraocular lens. extruded from a copolymer of CARDIOVASCULAR SUTURES glycolide and lactide and coated Swaged sutures designed to meet the CS ULTIMA* with a mixture of polyglactin 370 specific needs of heart and blood OPHTHALMIC NEEDLE (CS) and calcium stearate. vessel surgery. ETHICON trademark for needle with reduced side edge angles COBALT 60 CATGUT providing excellent penetration Outmoded term for surgical Source of irradiation used by necessary for ophthalmic surgery. gut suture. ETHICON, INC., to sterilize some Design facilitates knot rotation suture materials. Also used in during surgery. hospitals to treat some cancer patients. CHAPTER 7 81

CUTICULAR SUTURES E-PACK* PROCEDURE KIT EVISCERATION Sutures designed for skin closure. ETHICON trademark for single Protrusion of bowel through overwrapped organizer tray separated edges of abdominal DEAD SPACE containing multiple ETHICON wound closure. Pockets left in a tissue layer when suture products. Each E-PACK kit tissues are not in close may be customized with choice of EXPIRATION DATE approximation. sutures for specific procedures or Date on a suture product surgeon preferences. representing the time through DECONTAMINATION which satisfactory stability studies Process used to destroy ETHALLOY* NEEDLE ALLOY have been carried out. microorganisms known or thought ETHICON trademark for exclusive to be present on a surface or object. patented stainless steel alloy that is EXTRUSION OF KNOTS, KNOT 40 percent stronger than needles EXTRUSION, OR "SPITTING" DEHISCENCE made of 300 Series stainless Attempt by the human body to rid Total or partial separation of steel. Provides improved tissue itself of nonabsorbable sutures or wound edges. penetration, smoother needle-to- absorbable sutures which are not suture transition, and better flow completely absorbed (“foreign DERMABOND* through tissue. bodies”). Suture knots encapsulated TOPICAL SKIN ADHESIVE by cells may work their way to the (2-OCTYL CYANOACRYLATE) ETHIBOND* EXCEL skin surface months or even years ETHICON trademark for sterile, POLYESTER SUTURE after surgery. liquid topical skin adhesive for ETHICON trademark for braided approximation of wound edges of polyester suture coated with FASCIA trauma-induced lacerations or polybutilate coating. Areolar tissue layers under the skin surgical incisions. (superficial fascia) or fibrous tissue ETHIGUARD* BLUNT between muscles and forming the DISPENSER BOXES POINT NEEDLE sheaths of muscles or investing Gravity-fed vertical or horizontal ETHICON trademark for specially other structures such as nerves or boxes that readily dispense wound designed needle which has a blood vessels (deep fascia). closure products. Labels on boxes rounded tip. include product information. FDA ETHILON* NYLON SUTURE Abbreviation for federal Food and DOUBLE-ARMED SUTURE ETHICON trademark for sutures Drug Administration. Suture strand with a needle swaged made of monofilament nylon. at each end. GASTROINTESTINAL SUTURES ETHI-PACK* PRE-CUT SUTURE Sutures designed for use in EASY ACCESS* PACKAGING ETHICON trademark for anastomosis of bowel and stomach ETHICON trademark for patented pre-cut strands of nonabsorbable surgery. delivery system that presents the sutures without needles, sterile needle in position for immediate and nonsterile. GAUGE arming in the needleholder as soon Term used to express diameter of as the primary packet is opened. ETHYLENE OXIDE GAS suture strand. Chemical agent used to sterilize some suture materials. GENERAL CLOSURE SUTURES Sutures used in closing fascia, particularly in the abdominal wall. Also for hernia repair and other fascial defects. * Trademark 82 PRODUCT TERMS AND TRADEMARKS

GENTLE BEND* PACKAGE LABYRINTH* PACKAGE MERSILENE* POLYESTER FIBER ETHICON trademark for ETHICON trademark for unique STRIP/TAPE packaging designed to deliver package that dispenses straight, ETHICON trademark for a flat monofilament PROLENE* kink-free, pre-cut nonabsorbable band 5mm wide. Useful as a polypropylene suture to the surgical sutures. cerclage ligature in patients with an field in a straight usable form. incompetent cervix. Also used for LIGAPAK* DISPENSING REEL bladder support or repair and HEMO-SEAL* NEEDLE SUTURE ETHICON trademark for disc-like support of the rotator cuff in ETHICON trademark for a plastic reel that contains and the shoulder. needle/suture combination dispenses suture for ligation. manufactured using a swaging MERSILENE* POLYESTER method that provides a smoother LIGAPAK LIGATURE FIBER SUTURE needle-to-suture transition. ETHICON trademark for a length ETHICON trademark for uncoated Beneficial in reducing leakage of suture material wound on a reel, braided nonabsorbable suture from the suture line, especially in primarily used for ligating. material made of polyester polymer. cardiovascular procedures. LIGATING REEL MICRO-POINT* HYDROLYSIS Tube, plastic disc, or other device SPATULA NEEDLE Chemical process whereby a from which continuous ligating ETHICON trademark for compound or polymer reacts with material is unwound as blood vessels side-cutting ophthalmic needles water to cause an alteration or are tied. which are thin and flat in profile breakdown of the molecular and specially honed for exceptional structure. Synthetic absorbable LIGATURE sharpness. sutures are degraded in vivo by Strand of material used to tie off a this mechanism. blood vessel. MICRO-POINT* SURGICAL NEEDLE INFECTION LOOPED SUTURE ETHICON trademark for Invasion of body tissue by a Single strand of suture material ophthalmic needles which are pathogen. with both ends swaged onto a honed and polished to an extremely single needle. fine finish and sharpness. INTERRUPTED SUTURE TECHNIQUE MERSILENE* POLYESTER MICROSURGERY SUTURES Single stitches separately placed, FIBER MESH Sutures for surgeries in which an tied, and cut. ETHICON trademark for machine- operating microscope may be used knitted fabric which is used in to visualize the very small structures KEITH NEEDLE (KS) hernia repair and other fascial involved, e.g., blood vessels Straight needle with cutting edges, deficiencies that require addition of and nerves. used primarily for abdominal skin a reinforcing or bridging material. closure. Named for a Scottish MIL surgeon, Dr. Thomas Keith, who Unit of linear measurement, made the needle popular. equivalent to 0.001 inch. Frequently used to express wire diameter of KINK surgical needles. Undesirable deformation of a strand, such as a sharp bend in wire. CHAPTER 7 83

MODULAR SUTURE NONABSORBABLE SUTURE PERMA-HAND* SILK SUTURE STORAGE RACK Material which tissue enzymes can- ETHICON trademark for sutures Plastic modules of expandable not dissolve. Remains encapsulated specially processed to remove gum interlocking units that provide neat, when buried in tissues. Removed and impurities from raw silk before convenient storage of ETHICON postoperatively when used as skin braiding selected sizes into strands. suture dispenser boxes. suture. Also treated with mismo beeswax to reduce capillarity. MONOCRYL* NYLON (POLIGLCAPRONE 25) SUTURE Synthetic suture material made of PLAIN SURGICAL GUT ETHICON trademark for polyamide polymer. Untreated absorbable suture with monofilament synthetic absorbable short-term absorption profile. suture prepared from a copolymer OB-GYN SUTURES of glycolide and e-caprolactone. Needle/suture combinations PLASTIC SURGERY SUTURES particularly useful in obstetric and Sutures specifically designed to MONOFILAMENT gynecological operations. assist the surgeon in obtaining A single filament strand. excellent cosmetic results in plastic OPHTHALMIC SUTURES and reconstructive surgery. MULTIFILAMENT Small gauge sutures attached to Strand made of more than one ultrafine needles that meet exacting PLEDGETS twisted or braided filament. needs in ophthalmic surgery. Small pieces of TFE polymer felt used as a buttress under sutures in MULTIPASS NEEDLE OVERWRAP cardiovascular surgery. ETHICON trademark for patented Exterior packet which protects the coating process that enhances needle sterility of inner suture packet. POLYBUTILATE performance over multiple penetrations. A nonabsorbable nonreactive PACKAGE INSERT polyester lubricant developed by MULTI-STRAND PACKAGE Complete product information ETHICON, INC., as a coating for Multiple swaged sutures of one type inserted in every box of wound ETHIBOND EXCEL sutures. supplied in a single packet. closure products, as required by the FDA. POLYESTER FIBER NEEDLEHOLDER Synthetic material made of a Surgical instrument used to hold PC PRIME* NEEDLE (PC) polyester polymer of polyethylene and drive a surgical needle during ETHICON trademark for a terephthalate. suturing. conventional cutting needle with a NEEDLE/SUTURE geometry that reduces the angle of POLYPROPYLENE JUNCTION (SWAGE) the cutting edge. Requires less force Synthetic material of an isotactic Point at which eyeless needles and to penetrate tissue, minimizing crystalline stereoisomer of a linear suture strands are joined. tissue trauma in precision hydrocarbon polymer which will cosmetic surgery. not absorb fluids. NUROLON* BRAIDED NYLON SUTURE PDS* II (POLYDIOXANONE) POLYPROPYLENE BUTTONS SUTURE ETHICON trademark for Synthetic material made into ETHICON trademark for multifilament braided nylon suture. buttons. Useful in orthopaedic monofilament synthetic absorbable procedures such as tendon repair. suture prepared from the polyester Sutures are tied over buttons to poly (p-dioxanone). relieve underlying skin of excessive pressure.

* Trademark 84 PRODUCT TERMS AND TRADEMARKS

PRECISION COSMETIC PROLENE* POLYPROPYLENE REVERSE CUTTING NEEDLE NEEDLE (PC) SUTURE Needles produced by ETHICON Conventional cutting needles ETHICON trademark for synthetic Products, which have triangular specially polished and carefully nonabsorbable suture material made shapethroughout their entire length honed for aesthetic plastic surgery. of monofilament polypropylene. and cutting edge along the outside needle curvature to prevent PRECISION POINT NEEDLE PRONOVA* POLY tissue cutout. Needles with Reverse-cutting needles specially (HEXAFLUOROPROPYLENE-VDF) longitudinal grooves on the inner SUTURE polished and carefully honed for and outer flattened curvatures. Ribs plastic surgery. ETHICON trademark for synthetic engage the needleholder jaw and nonabsorbable suture material made help to minimize movement of the PRE-CUT SUTURES of a polymer blend of poly needle in the needleholder. Strands of suture material packaged (vinylidene fluoride) and poly pre-cut into various lengths. (vinylidene fluoride-cohexafluoro- SABRELOC* SPATULA NEEDLE propylene). ETHICON trademark for PRIMARY PACKET ophthalmic needles. Side-cutting PROXI-STRIP* SKIN CLOSURES Suture packet which contains the spatula-shaped edges separate the ETHICON trademark for adhesive sterile suture. ultrathin layers of scleral or comeal strips used for skin closure. tissue without cutting through. PRIMARY WOUND CLOSURE RELAY* SUTURE The approximation of wound edges SAFETY ORGANIZER TRAY DELIVERY SYSTEM to facilitate rapid healing. ETHICON design for a suture tray ETHICON trademark for the which delivers multistrand products. packaging of single strand and PRODUCT CODE Offers single strand delivery, and a multistrand sutures. Provides Numbers or combination of letters singulated needle park which delivery of one suture at a time, and numbers which identify a permits one-step arming and one-step arming, individual needle specific product. tanglefree straight suture strands. parks, and straight, tangle-free sutures ready for use. PROLENE* POLYPROPYLENE SECONDARY CLOSURE HERNIA SYSTEM Retention sutures placed ETHICON trademark for a sterile, RETENTION SUTURE BOLSTERS approximately 2 inches from wound pre-shaped, three-dimensional edges to reinforce primary closure Surgical tubing used to sheath device constructed of an onlay patch and protect it from stress. connected by a mesh cylinder to a retention sutures to prevent cutting circular underlay patch. Used for the skin. Also known as "Booties." SIDE-FLATTENED NEEDLES the repair of indirect and direct Configuration of stainless steel alloy RETENTION SUTURE BRIDGE inguinal hernia defects. needles designed to increase Clear plastic device designed with a strength and reduce bending when PROLENE* POLYPROPYLENE capstan to permit postoperative penetrating vascular prostheses or MESH wound management by adjusting calcified tissues. ETHICON trademark for mesh the tension of retention sutures, made of polypropylene which is preventing suture crosshatching on SINGLE STRAND DELIVERY knitted by a process which inter- the skin. Terminology used to describe the links each fiber juncture. Used for delivery of one straight suture at a the repair of abdominal wall defects time from the RELAY suture and tissue deficiencies. delivery system. CHAPTER 7 85

STERILE SUTURE BOOK TRANSVERSE GROUND Free of living microorganisms Sterile towel folded by the scrub NEEDLES (TG) (bacteria and their spores, person and used to contain multiple Spatulated ophthalmic needles viruses, etc.). sutures. specially honed to a long, sharp, slim tip. STERILE TECHNIQUE SWAGED SUTURE Collectively, all the efforts made and Strand of material with eyeless nee- TRU-GAUGING procedures followed to exclude dle attached by the manufacturer. ETHICON process which ensures microorganisms from the operative uniform diameter and uniformly wound and field. TAPERCUT* higher tensile strength of SURGICAL NEEDLE surgical gut. STERILIZATION ETHICON trademark for a needle Process by which all living which has a 1/16" triangular tip with TRU-PERMANIZING microorganisms on an object are three cutting edges. Remainder of ETHICON process of treating silk destroyed. needle has a gradually tapered body. for noncapillarity.

SUPER-SMOOTH FINISH TAPER POINT NEEDLE (TP) TUBING FLUID An exclusive process that provides a Needle with a body that gradually Solution inside packets of surgical finish on most ETHICON needles, tapers to a sharp point, making the gut and collagen. Purpose is to enabling the needles to penetrate smallest possible hole in tissue. maintain material (and needle, if and pass through the toughest tissue attached) in optimum condition for with minimal resistance. TENSILE STRENGTH immediate use upon withdrawal Amount of tension or pull, from the packet. SURGICAL GUT expressed in pounds, which a Absorbable suture made from suture strand will withstand before UMBILICAL TAPE serosal layer of beef intestine or it breaks. Woven cotton tape, classified as a submucosal layer of sheep intestine. ligature, used as a gentle means of TIES (LIGATURES) retracting vessels in cardiovascular SURGICAL STAINLESS Strands of suture used to tie off the and pediatric surgery and for tying STEEL SUTURE ends of severed blood vessels: free off the umbilicus of the newbom. Nonabsorbable suture made of or freehand—single strands used as 316L steel alloy. individual ties; continuous—long UROLOGICAL SUTURES strands unwound from a reel or Sutures designed to meet the needs SUTUPAK* PRE-CUT other device as blood vessels are of surgery performed by urologists. STERILE SUTURES tied; suture ligature—strand on a Features 5/8 circle needles which ETHICON trademark for packet needle used to transfix (suture) a turn out of tissue quickly. containing multiple pre-cut lengths large blood vessel to ensure security of suture material without needles, against knot slippage; stick tie—a VICRYL* (POLYGLACTIN 910) sterile and ready for immediate use. suture ligature or a single strand MESH handed to surgeon for ligating with ETHICON trademark for mesh SUTURE a hemostat clamped on one suture prepared from a copolymer of Material used to approximate end; transfixion suture—suture glycolide and lactide. An absorbable (sew) tissues or tie off (ligate) ligature. material used as a buttress to blood vessels. provide temporary support during healing.

* Trademark 86 PRODUCT TERMS AND TRADEMARKS

VICRYL* (POLYGLACTIN 910) PERIODONTAL MESH ETHICON trademark for mesh prepared from a copolymer of gly- colide and lactide. An absorbable material used in periodontal surgery for guided tissue regeneration.

VISI-BLACK* SURGICAL NEEDLES ETHICON trademark for surgical needles with a black surface finish to enhance visibility in the operative site.

WOUND DISRUPTION Separation of wound edges.

* Trademark CHAPTER 8

PRODUCT INFORMATION 88 PRODUCT INFORMATION

Coated VICRYL* Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, (Polyglactin 910) Suture such as those found in the urinary or biliary tracts, may result in calculus U.S.P., EXCEPT FOR DIAMETER formation. As an absorbable suture, coated VICRYL suture may act transiently as a foreign body. Acceptable surgical practice should be followed DESCRIPTION for the management of contaminated or infected wounds. Coated VICRYL* (polyglactin 910) suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% PRECAUTIONS L-lactide. Coated VICRYL suture is prepared by coating VICRYL suture material with a mixture composed of equal parts of copolymer of glycolide and lactide Skin sutures which must remain in place longer than 7 days may cause (polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and localized irritation and should be snipped off or removed as indicated. polyglactin 370 with calcium stearate have been found to be nonantigenic, Under some circumstances, notably orthopaedic procedures, immobilization of nonpyrogenic and elicit only a mild tissue reaction during absorption. joints by external support may be employed at the discretion of the surgeon. The sutures are available dyed and undyed (natural). Consideration should be taken in the use of absorbable sutures in tissues with Coated VICRYL sutures are U.S.P. except for diameters in the following sizes: poor blood supply as suture extrusion and delayed absorption may occur. MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. In handling this or any other suture material, care should be taken to avoid U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Coated VICRYL 6-0 .008 sutures, which are treated to enhance handling characteristics, require the 5-0 .016 accepted surgical technique of flat and square ties with additional throws as 4-0 .017 warranted by surgical circumstance and the experience of the surgeon. 3-0 .018 2-0 .004 Avoid prolonged exposure to elevated temperatures. 0 .022 To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the INDICATIONS point. Reshaping needles may cause them to lose strength and be less resistent to bending and breaking. Users should exercise caution when handling Coated VICRYL suture is indicated for use in general soft tissue approximation surgical needles to avoid inadvertent needle sticks. Discard used needles in and/or ligation, including use in ophthalmic procedures, but not for use in "sharps" container. cardiovascular and neurological tissues.

ADVERSE REACTIONS ACTIONS Adverse effects associated with the use of this device include wound Coated VICRYL suture elicits a minimal acute inflammatory reaction in tissue dehiscence, failure to provide adequate wound support in closure of the sites and ingrowth of fibrous connective tissue. Progressive loss of tensile strength where expansion, stretching, or distension occur, failure to provide adequate and eventual absorption of coated VICRYL suture occurs by means of wound support in elderly, malnourished or debilitated patients or in patients hydrolysis, where the copolymer degrades to glycolic and lactic acids which suffering from conditions which may delay wound healing, infection, minimal are subsequently absorbed and metabolized in the body. Absorption begins as acute inflammatory tissue reaction, localized irritation when skin sutures are a loss of tensile strength followed by a loss of mass. Implantation studies in left in place for greater than 7 days, suture extrusion and delayed absorption in rats indicate that coated VICRYL suture retains approximately 75% of the tissue with poor blood supply, calculi formation in urinary and biliary tracts original tensile strength at two weeks post implantation. At three weeks, when prolonged contact with salt solutions such as urine and bile occurs, and approximately 50% of the original strength is retained for sizes 6-0 and larger transitory local irritation at the wound site. Broken needles may result in and approximately 40% of its original strength is retained for sizes 7-0 and extended or additional surgeries or residual foreign bodies. Inadvertent needle smaller. At four weeks, approximately 25% of the original strength is retained sticks with contaminated surgical needles may result in the transmission of for sizes 6-0 and larger. All of the original tensile strength is lost by five weeks bloodborne pathogens. post implantation. Absorption of coated VICRYL suture is essentially complete between 56 and 70 days. APPROXIMATE % ORIGINAL HOW SUPPLIED DAYS IMPLANTATION STRENGTH REMAINING Coated VICRYL sutures are available sterile, as braided dyed (violet) and undyed (natural) strands in sizes 8-0 through 3 (metric sizes 0.4-6), in a variety 14 Days 75% of lengths, with or without needles, and on LIGAPAK*dispensing reels. 21 Days (6-0 and larger) 50% 21 Days (7-0 and smaller) 40% Coated VICRYL sutures are also available in size 8-0 with attached beads for 28 Days 25% use in ophthalmic procedures. Coated VICRYL sutures are also available in sizes 4-0 through 2 (metric sizes 1.5-5.0) attached to CONTROL RELEASE* removable needles. Coated VICRYL sutures are available in one, two, and three CONTRAINDICATIONS dozen boxes. This suture, being absorbable, should not be used where extended approximation of tissue is required. 389389 *Trademark ©ETHICON,INC. 1996 WARNINGS Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing coated VICRYL suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require additional support. CHAPTER 8 89

PRECAUTIONS Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated. (Polyglactin 910) Suture Under some circumstances, notably orthopaedic procedures, immobilization of U.S.P., EXCEPT FOR DIAMETER joints by external support may be employed at the discretion of the surgeon. Consideration should be taken in the use of absorbable sutures in tissues with DESCRIPTION poor blood supply as suture extrusion and delayed absorption may occur. Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture is a synthetic In handling this or any other suture material, care should be taken to avoid absorbable, sterile, surgical suture composed of a copolymer made from 90% damage from handling. Avoid crushing or crimping damage due to application of glycolide and 10% L-lactide. Coated VICRYL Plus Antibacterial Suture is coated surgical instruments such as forceps or needle holders. Coated VICRYL Plus with a mixture composed of equal parts of a copolymer of glycolide and lactide Antibacterial Sutures, which are treated to enhance handling characteristics, (Polyglactin 370) and calcium stearate. The suture contains Irgacare MP** require the accepted surgical technique of flat and square ties with additional (triclosan), a broad-spectrum antibacterial agent at no more than 472ug/m. The throws as warranted by surgical circumstance and the experience of the surgeon. copolymers in this product have been found to be nonantigenic, nonpyrogenic Avoid prolonged exposure to elevated temperatures. and elicit only a mild tissue reaction during absorption. The suture is available undyed (natural) or dyed (D&C Violet No.2). To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Coated VICRYL Plus Antibacterial Sutures meet all the requirements established Reshaping needles may cause them to lose strength and be less resistent to bend- by the United States Pharmacopoeia (U.S.P.) for Synthetic Absorbable Surgical ing and breaking. Users should exercise caution when handling surgical needles Suture (except for diameter) in the following sizes: to avoid inadvertent needle sticks. Discard used needles in “sharps” container. MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) ADVERSE REACTIONS 5-0 .016 Adverse effects associated with the use of this device include wound dehiscence, 4-0 .017 failure to provide adequate wound support in closure of the sites where expan- 3-0 .018 sion, stretching, or distension occur, failure to provide adequate wound support 2-0 .004 in elderly, malnourished or debilitated patients or in patients suffering from con- 0 .022 ditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater INDICATIONS than 7 days, suture extrusion and delayed absorption in tissue with poor blood Coated VICRYL Plus Antibacterial Suture is indicated for use in general soft supply, calculi formation in urinary and biliary tracts when prolonged contact with tissue approximation and/or ligation, except for ophthalmic, cardiovascular and salt solutions such as urine and bile occurs, and transitory local irritation at the neurological tissues. wound site, as well as allergic reaction to Irgacare MP (triclosan). Broken needles may result in extended or additional surgeries or residual foreign bodies. ACTIONS Inadvertent needle sticks with contaminated surgical needles may result in the Coated VICRYL Plus Antibacterial Suture elicits a minimal acute inflammatory transmission of bloodborne pathogens. reaction in tissue and ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of Coated VICRYL Plus Antibacterial HOW SUPPLIED Suture occurs by means of hydrolysis, where the copolymer degrades to glycolic Coated VICRYL Plus Antibacterial Sutures are available sterile, as braided dyed and lactic acids, which are subsequently absorbed and metabolized in the body. (violet) and undyed (natural) strands in sizes 5-0 through 0 (metric sizes 1 - 3.5) Absorption begins as a loss of tensile strength followed by a loss of mass. in a variety of lengths, with or without needles, and on LIGAPAK* dispensing Implantation studies in rats indicate that Coated VICRYL Plus Antibacterial Suture reels. retains approximately 75% of the original tensile strength at two weeks post Needles may be attached permanently or as CONTROL RELEASE* removable implantation. At three weeks, approximately 50% of the original strength is needles enabling the needles to be pulled off instead of being cut off. Coated retained. At four weeks, approximately 25% of the original strength is retained. All VICRYL Plus Antibacterial Sutures are available in one, two and three dozen of the original tensile strength is lost by five weeks post implantation. Absorption boxes. Full details are contained in the catalog. of Coated VICRYL Plus Antibacterial Suture is essentially complete between 56 and 70 days. APPROXIMATE % ORIGINAL LOT DAYS IMPLANTATION STRENGTH REMAINING Batch number 14 Days 75% See instructions 21 Days 50% Use by Ð year & month for use 28 Days 25% Using zone of inhibition studies, Coated VICRYL Plus Antibacterial Suture has Method of sterilizationÐ Do not reuse/ been shown to inhibit colonization of the suture by Staphylococcus aureus and Ethylene Oxide resterilize Staphylococcus epidermidis. The clinical significance of this finding is unknown. CONTRAINDICATIONS This suture, being absorbable, should not be used where extended approximation of tissue under stress is required. Coated VICRYL Plus Antibacterial Suture should not be used in patients with known allergic reactions to Irgacare MP (triclosan). A division of WARNINGS a company Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Coated VICRYL Plus Antibacterial Suture for *Trademark of ETHICON, INC. wound closure, as risk of wound dehiscence may vary with the site of application **Trademark of Ciba Specialty Chemicals Corporation. and the suture material used. Physicians should consider the in vivo performance ©ETHICON,INC. 2002 (under ACTIONS section) when selecting a suture. The use of this suture may 389595.R01 be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require additional support. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus forma- tion. As an absorbable suture, Coated VICRYL Plus Antibacterial Suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. 90 PRODUCT INFORMATION

Coated VICRYL* RAPIDE (Polyglactin 910) WARNINGS Users should be familiar with surgical procedures and techniques involving Braided Coated Synthetic Absorbable absorbable sutures before employing coated VICRYL RAPIDE suture for wound closure, as a risk of wound dehiscence may vary with the site of application and Suture, Undyed the suture material used. Physicians should consider the in vivo performance when selecting a suture. The use of this suture may be inappropriate in Non-U.S.P. elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. DESCRIPTION Coated VICRYL* RAPIDE (polyglactin 910) suture is a synthetic absorbable ster- Do not resterilize. Discard opened packages and unused sutures. ile surgical suture composed of a copolymer made from 90% glycolide and 10% As with any foreign body, prolonged contact of any suture with salt solutions, L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. such as those found in the urinary or biliary tracts, may result in calculus The characteristic of rapid loss of strength is achieved by use of a polymer formation. As an absorbable suture, coated VICRYL RAPIDE suture may act material with a lower molecular weight than coated VICRYL* (polyglactin 910) transiently as a foreign body. suture. Acceptable surgical practice should be followed for the management of Coated VICRYL RAPIDE sutures are obtained by coating the braided suture contaminated or infected wounds. material with a mixture composed of equal parts of copolymer of glycolide and As this is an absorbable suture material, the use of supplemental nonab- lactide (polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and sorbable sutures should be considered by the surgeon in the closure of sites polyglactin 370 with calcium stearate have been found to be nonantigenic, which may undergo expansion, stretching or distention, or which may require nonpyrogenic and elicit only a mild tissue reaction during absorption. additional support. Coated VICRYL RAPIDE sutures are only available undyed. Although this suture is a synthetic absorbable suture, its performance charac- teristics are intended to model the performance of collagen (surgical gut) PRECAUTIONS suture. The knot tensile strength of coated VICRYL RAPIDE suture meets U.S.P. Skin sutures which remain in place longer than 7 days may cause localized knot tensile strength requirements for collagen sutures, however, Coated irritation and should be snipped off or removed as indicated. VICRYL RAPIDE suture strength is up to 26% less than knot tensile strength Under some circumstances, notably orthopaedic procedures, immobilization of requirements for synthetic absorbable sutures. joints by external support may be employed at the discretion of the surgeon. Consideration should be taken in the use of absorbable sutures in tissues with MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. poor blood supply as suture extrusion and delayed absorption may occur. U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE(mm) In handling this or any other suture material, care should be taken to avoid 5-0 .016 damage from handling. Avoid crushing or crimping damage due to application 4-0 .017 of surgical instruments such as forceps or needle holders. 3-0 .018 Coated VICRYL RAPIDE suture, which is treated with coating to enhance 2-0 .010 handling characteristics, requires the accepted surgical technique of flat and 0 .022 square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon. INDICATIONS Avoid prolonged exposure to elevated temperatures. Coated VICRYL RAPIDE synthetic absorbable suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short To avoid damaging needle points and swage areas, grasp the needle in an area term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is one-third (1/3) to one-half (1/2) of the distance from the swaged end to the not intended for use in ligation, ophthalmic, cardiovascular or neurological point. Reshaping needles may cause them to lose strength and be less procedures. resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid in advertent needle sticks. Discard used needles in “sharps” containers. ACTIONS Coated VICRYL RAPIDE suture, when used in closure of skin and mucous mem- branes, typically begins to fall off 7-10 days post-operatively and can be wiped ADVERSE REACTIONS off subsequently with sterile gauze. Natural mechanical abrasion of the sutures Adverse effects associated with the use of this device include wound dehis- while in situ may also accelerate this disappearance rate. Rapid loss of tensile cence, failure to provide adequate wound support in closure of the sites where strength may preclude the need for stitch removal. expansion, stretching, or distension occur, failure to provide adequate wound Coated VICRYL RAPIDE elicits a minimal to moderate acute inflammatory support in elderly, malnourished or debilitated patients or in patients suffering reaction in tissue. Progressive loss of tensile strength and eventual absorption from conditions which may delay wound healing, infection, minimal acute of coated VICRYL RAPIDE occurs by means of hydrolysis, where the copolymer inflammatory tissue reaction, localized irritation when skin sutures are left in degrades to glycolic and lactic acids which are subsequently absorbed and place for greater than 7 days, suture extrusion and delayed absorption in tissue metabolized in the body. Absorption begins as a loss of tensile strength with poor blood supply, calculi formation in urinary and biliary tracts when pro- followed by a loss of mass. longed contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site. Broken needles may result in extended or Subcutaneous tissue implantation studies of coated VICRYL RAPIDE sutures in additional surgeries or residual foreign bodies. Inadvertent needle sticks with rats show that 5 days post-implantation approximately 50% of the original contaminated surgical needles may result in the transmission of bloodborne tensile strength remains. All of the original tensile strength is lost by approxi- pathogens. mately 10 to 14 days post-implantation. Intramuscular implantation studies in rats show that the absorption of these sutures occurs thereafter and is essentially complete by 42 days. HOW SUPPLIED Coated VICRYL RAPIDE sutures are available sterile, undyed and attached to stainless steel needles of varying types and sizes. CONTRAINDICATIONS Due to the rapid loss of tensile strength, this suture should not be used where Coated VICRYL RAPIDE sutures are available in various lengths in sizes 5-0 to extended approximation of tissues under stress is required or where wound 1 (1.0 to 4.0 metric) in one and three dozen boxes. support beyond 7 days is required.

389307 *Trademark ©ETHICON, INC. 1994 CHAPTER 8 91 92 PRODUCT INFORMATION

ETHIBOND* EXCEL POLYESTER SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid NONABSORBABLE SURGICAL SUTURE, U.S.P. damage from handling. Avoid crushing or crimping damage due to application Except for size 6-0 diameter of surgical instruments such as forceps or needle holders. As with any suture material, adequate knot security requires the accepted DESCRIPTION surgical technique of flat and square ties with additional throws as warranted ETHIBOND* EXCEL polyester suture is a nonabsorbable, braided, sterile, by surgical circumstance and the experience of the surgeon. surgical suture composed of Poly (ethylene terephthalate). It is prepared from To avoid damaging needle points and swage areas, grasp the needle in an area fibers of high molecular weight, long-chain, linear polyesters having recurrent one-third (1/3) to one-half (1/2) of the distance from the swaged end to the aromatic rings as an integral component. ETHIBOND EXCEL suture is uniform- point. Reshaping needles may cause them to lose strength and be less ly coated with polybutilate or poly {oxy-1, 4 butanediyloxy (1, 6-dioxo-1, resistant to bending and breaking. Users should exercise caution when 6 hexanediyl)}. The highly adherent coating is a relatively nonreactive handling surgical needles to avoid inadvertent needle sticks. Discard used nonabsorbable compound which acts as a lubricant to mechanically improve needles in "sharps" containers. the physical properties of the uncoated suture by improving ease of passage through tissues and by providing overall improved handling qualities as contrasted to the braided, uncoated fiber. ADVERSE REACTIONS ETHIBOND EXCEL sutures are braided for optimal handling properties, and for good visibility in the surgical field, are dyed green. Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged Size 6-0 ETHIBOND EXCEL sutures are U.S.P., except for diameter. contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. may result in the transmission of bloodborne pathogens. U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) 6-0 0.024 HOW SUPPLIED ETHIBOND EXCEL sutures are available as sterile, braided, green and undyed INDICATIONS (white) strands in sizes 7-0 through 5 (metric sizes 0.5-7) in a variety of lengths, ETHIBOND EXCEL suture is indicated for use in general soft tissue with and without permanently attached needles. approximation and/or ligation, including use in cardiovascular, ophthalmic and ETHIBOND EXCEL sutures, green, braided, in sizes 4-0 through 1 (metric sizes neurological procedures. 1.5-4) are also available attached to CONTROL RELEASE* removable needles. ETHIBOND EXCEL sutures, green and undyed, are also available attached to ACTIONS TFE polymer pledgets measuring 1/8" x 1/8" x 1/16" (3.0mm x 3.0mm x 1.5mm), 1/4" x 1/8" x 1/16" (7.0mm x 3.0mm x 1.5mm). ETHIBOND EXCEL suture elicits a minimal acute inflammatory reaction in ETHIBOND EXCEL sutures are available in one, two and three dozen boxes. tissue, followed by a gradual encapsulation of the suture by fibrous connective tissue. Implantation studies in animals show no meaningful decline in polyester suture strength over time. Both polyester fiber suture material and the polybutilate coating are pharmacologically inactive. 389397 *Trademark ©ETHICON,INC. 1996

CONTRAINDICATIONS None known.

WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing ETHIBOND EXCEL suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds. CHAPTER 8 93

ETHILON* NYLON SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid NONABSORBABLE SURGICAL SUTURES, U.S.P. damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. DESCRIPTION As with any suture material, adequate knot security requires the accepted sur- ETHILON* nylon suture is a nonabsorbable, sterile surgical monofilament gical technique of flat and square ties, with additional throws as warranted by suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. surgical circumstance and the experience of the surgeon. The use of addition- ETHILON sutures are dyed black or green to enhance visibility in tissue. The al throws may be particularly appropriate when knotting monofilaments. suture is also available undyed (clear). To avoid damaging needle points and swage areas, grasp the needle in an area ETHILON suture meets all requirements established by the United States one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" INDICATIONS containers. ETHILON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehis- cence, gradual loss of tensile strength over time, calculi formation in urinary ACTIONS and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and transi- ETHILON suture elicits a minimal acute inflammatory reaction in tissue, which tory local irritation at the wound site. Broken needles may result in extended or is followed by gradual encapsulation of the suture by fibrous connective tissue. additional surgeries or residual foreign bodies. Inadvertent needle sticks with While nylon is not absorbed, progressive hydrolysis of the nylon in vivo may contaminated surgical needles may result in the transmission of bloodborne result in gradual loss over time of tensile strength. pathogens.

CONTRAINDICATIONS HOW SUPPLIED Due to the gradual loss of tensile strength which may occur over prolonged ETHILON sutures are available as sterile monofilament strands in U.S.P. sizes periods in vivo, nylon suture should not be used where permanent retention of 11-0 through 2 (metric sizes 0.1-5.0) in a variety of lengths, with and without tensile strength is required. permanently attached needles. ETHILON sutures are available in one, two and three dozen boxes. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing ETHILON suture for wound closure, 389355 *Trademark ©ETHICON, INC. 1995 as the risk of wound dehiscence may vary with the site of application and the suture material used. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. Do not resterilize. Discard open packages and unused sutures. 94 PRODUCT INFORMATION

FAST ABSORBING PRECAUTIONS In handling this or any other suture material, care should be taken to avoid SURGICAL GUT (PLAIN) damage from handling. Avoid crushing or crimping damage due to application ABSORBABLE SURGICAL SUTURES of surgical instruments such as forceps or needle holders. Surgical gut sutures require the accepted surgical technique of flat and square ties with additional Non-U.S.P. throws as warranted by surgical circumstance and the experience of the surgeon. DESCRIPTION Under some circumstances, notably orthopaedic procedures, immobilization of Fast absorbing surgical gut suture is a strand of collagenous material prepared joints by external support may be employed at the discretion of the surgeon. from the submucosal layers of the small intestine of healthy sheep, or from the The surgeon should avoid unnecessary tension when running down knots, to serosal layers of the small intestine of healthy cattle. reduce the occurrence of surface fraying and weakening of the strand. Fast absorbing surgical gut sutures are sterile and elicit only a slight to Avoid prolonged exposure to elevated temperatures. minimal tissue reaction during absorption. To avoid damaging needle points and swage areas, grasp the needle in an area Fast absorbing surgical gut sutures differ from U.S.P. minimum strength one-third (1/3) to one-half (1/2) of the distance from the swaged end to requirements by less than 30%. the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used INDICATIONS needles in "sharps" containers. Fast absorbing surgical gut sutures are intended for dermal (skin) suturing only. They should be utilized only for external knot tying procedures. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound ACTIONS dehiscence, variable rates of absorption over time (depending on such factors The results of implantation studies of fast absorbing surgical gut sutures in the as the type of suture used, the presence of infection and the tissue site), failure skin of animals indicate that nearly all of its original strength is lost within to provide adequate wound support in closure of sites where expansion, approximately seven (7) days of implantation. stretching or distention occur, etc., unless additional support is supplied When surgical gut suture is placed in tissue, a moderate tissue inflammation through the use of nonabsorbable suture material, failure to provide adequate occurs which is characteristic of foreign body response to a substance. This is wound support in elderly, malnourished or debilitated patients or in patients followed by a loss of tensile strength followed by a loss of suture mass, as the suffering from cancer, anemia, obesity, diabetes, infection or other conditions proteolytic enzymatic digestive process dissolves the surgical gut. This process which may delay wound healing, allergic response in patients with known continues until the suture is completely absorbed. Many variable factors may sensitivities to collagen which may result in an immunological reaction result- affect the rate of absorption. Some of the major factors which can affect tensile ing in inflammation, tissue granulation or fibrosis, wound suppuration and strength loss and absorption rates are: bleeding, as well as sinus formation, infection, moderate tissue inflammatory 1. Type of suture - plain gut generally absorbs more rapidly than chromic gut. response characteristic of foreign body response, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and 2. Infection - surgical gut is absorbed more rapidly in infected tissue than in bile occurs, and transitory local irritation at the wound site. Broken needles non-infected tissue. may result in extended or additional surgeries or residual foreign bodies. 3. Tissue sites - surgical gut will absorb more rapidly in tissue where increased Inadvertent needle sticks with contaminated surgical needles may result in the levels of proteolytic enzymes are present, as in the secretions exhibited in transmission of bloodborne pathogens. the stomach, cervix and vagina. Data obtained from implantation studies in rats show that the absorption of these sutures is essentially complete by the twenty-first (21st) to forty-second HOW SUPPLIED (42nd) post implantation day. Fast absorbing surgical gut sutures are available in sizes 5-0 (metric size 1.5) and 6-0 (metric size 1.0) with needles attached in one, two and three dozen CONTRAINDICATIONS boxes. These sutures, being absorbable, should not be used where prolonged approximation of tissue under stress is required. These sutures have been designed to absorb at a rapid rate and must be used on dermal tissue only. 389359 *Trademark ©ETHICON, INC. 1995 These sutures should never be used on internal tissue. The use of this suture is contraindicated in patients with known sensitivities or allergies to collagen, as gut is a collagen based material.

WARNINGS Users should be familiar with surgical procedures and techniques involving gut suture before using fast absorbing surgical gut suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance when selecting a suture for use in patients. The use of this suture may be inappropriate in elderly, malnourished, or debil- itated patients, or in patients suffering from conditions which may delay wound healing. As this is an absorbable material, the use of supplemental non- absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. As an absorbable suture, fast absorbing surgical gut may act tran- siently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. Do not resterilize. Discard open packages and unused sutures. Store at room temperature. Certain patients may be hypersensitive to collagen and might exhibit an immunological reaction resulting in inflammation, tissue granulation or fibro- sis, wound suppuration and bleeding, as well as sinus formation. CHAPTER 8 95

MERSILENE* POLYESTER FIBER SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid NONABSORBABLE SURGICAL SUTURE, U.S.P. damage from handling. Avoid crushing or crimping damage due to application Except for size 6-0 diameter of surgical instruments such as forceps or needle holders. The use of addition- al throws is particularly appropriate when knotting monofilament sutures. DESCRIPTION As with any suture material, adequate knot security requires the accepted MERSILENE* polyester suture is a nonabsorbable, braided, sterile, surgical surgical technique of flat and square ties with additional throws as warranted suture composed of Poly (ethylene terephthalate). It is prepared from fibers of by surgical circumstance and the experience of the surgeon. high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. MERSILENE sutures are braided for optimal To avoid damaging needle points and swage areas, grasp the needle in an area handling properties, and for good visibility in the surgical field, are dyed green. one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less Size 6-0 MERSILENE sutures are U.S.P., except for diameter. resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. needles in "sharps" containers. U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) 6-0 0.024 ADVERSE REACTIONS Adverse effects associated with the use of this device include wound INDICATIONS dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal MERSILENE suture is indicated for use in general soft tissue approximation acute inflammatory tissue reaction and transitory local irritation at the wound and/or ligation, including use in cardiovascular, ophthalmic and neurological site. Broken needles may result in extended or additional surgeries or residual procedures. foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. ACTIONS MERSILENE suture elicits a minimal acute inflammatory reaction in tissue, HOW SUPPLIED followed by a gradual encapsulation of the suture by fibrous connective MERSILENE sutures are available as sterile, braided, green and undyed (white) tissue. Implantation studies in animals show no meaningful decline in strands in sizes 6-0 through 5 (metric sizes 0.7-7) in a variety of lengths, with polyester suture strength over time. The polyester fiber suture material is and without permanently attached needles. pharmacologically inactive. MERSILENE sutures are also available in green monofilament in sizes 10-0 and 11-0 (metric sizes 0.2-0.1). CONTRAINDICATIONS MERSILENE sutures, green, braided in U.S.P. size 0 (metric size 3.5) are also None known. available attached to CONTROL RELEASE* removable needles. MERSILENE sutures are available in one, two and three dozen boxes. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing MERSILENE suture for wound 389395 *Trademark ©ETHICON,INC. 1996 closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds. 96 PRODUCT INFORMATION

MERSILENE* POLYESTER FIBER MESH WARNINGS MERSILENE mesh is provided by ETHICON, INC. as a sterile product. Unused Nonabsorbable Synthetic Surgical Mesh MERSILENE Mesh which has been removed from the package may be resteril- STERILE ized not more than one time by a conventional stream autoclaving process at conditions of 250˚F (121˚C) for 20 minutes. MERSILENE mesh may also be flash autoclaved not more than one time at conditions of 270˚F (132˚C) for DESCRIPTION 10 minutes. Resterilization under any other conditions or by any other means MERSILENE* Polyester Fiber Mesh is constructed from polyethylene is neither recommended nor endorsed by ETHICON, INC. terephthalate, the same material used to make MERSILENE* Polyester Fiber Suture, Nonabsorbable Surgical Suture, U.S.P. (ETHICON, INC.) MERSILENE If this product should become stained with blood or soiled, it should not be Polyester Fiber Mesh affords excellent strength, durability and surgical resterilized for reuse. adaptability, along with maximal porosity for necessary tissue ingrowth. The mesh is approximately 0.010 inches thick and is a highly flexible and compliant material. PRECAUTIONS A minimum of 6.5mm (1/4 inch) of mesh should extend beyond the suture line. MERSILENE mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The fiber ADVERSE REACTIONS junctions are not subject to the same work fatigue exhibited by more rigid No significant adverse clinical reactions to MERSILENE mesh have been metallic meshes. This bi-directional elastic property allows adaption to various reported. The use of nonabsorbable MERSILENE mesh in a wound that is stresses encountered in the body. contaminated or infected could lead to fistula formation and/or extrusion of the mesh. ACTIONS MERSILENE mesh is a nonabsorbable mesh used to span and reinforce INDICATIONS FOR USE traumatic or surgical wounds to provide extended support during and It is recommended that nonabsorbable sutures be placed 6.5 to 12.5mm (1/4 to following wound healing. Animal studies show that implantation of 1/2 inch) apart at a distance approximately 6.5mm (1/4 inch) from edge of the MERSILENE mesh elicits a minimum to slight inflammatory reaction, which is mesh. Some surgeons prefer to suture and uncut section of mesh that is transient and is followed by the deposition of a thin fibrous layer of tissue considerably large than the defect into position over the wound. The opposite which can grow through the interstices of the mesh, thus incorporating the sides are then sutured to assure proper closure under correct tension. When mesh into adjacent tissue. The mesh remains soft and pliable, and normal the margin sutures have all been placed, the extra mesh is trimmed away. wound healing is not noticeably impaired. The material is not absorbed nor is it subject to degradation or weakening by the action of tissue enzymes. HOW SUPPLIED INDICATIONS MERSILENE mesh is available in single packets as sterile, undyed (white) sheets in two sizes. The sizes available are 6 x 11cm (2.5 x 4.5 inches) and 30 This mesh may be used for the repair of hernia and other fascial deficiencies x 30cm (12 x 12 inches). Each sheet is 0.25mm (0.010 inch) thick. that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

389131 *Trademark ©ETHICON, INC. 1987 CONTRAINDICATIONS When this mesh is used in infants or children with future growth potential, the surgeon should be aware that this product will not stretch significantly as the patient grows. MERSILENE polyester fiber mesh in contaminated wounds should be used with the understanding that subsequent infection may require removal of the material. CHAPTER 8 97

( ) As this is an absorbable suture material, the use of supplemental MONOCRYL* Poliglecaprone 25 Suture nonabsorbable sutures should be considered by the surgeon in the closure of SYNTHETIC ABSORBABLE SUTURE, the sites which may undergo expansion, stretching or distention, or which may U.S.P., EXCEPT FOR DIAMETER require additional support.

DESCRIPTION PRECAUTIONS Skin sutures which must remain in place longer than 7 days may cause local- MONOCRYL* (poliglecaprone 25) suture is a monofilament synthetic ized irritation and should be snipped off or removed as indicated. Subcuticular absorbable surgical suture prepared from a copolymer of glycolide and sutures should be placed as deeply as possible to minimize the erythema and epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be induration normally associated with absorption. nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon. MONOCRYL sutures are U.S.P. except for diameters in the following sizes: Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion and delayed absorption may occur. MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. In handling this or any other suture material, care should be taken to avoid U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) damage from handling. Avoid crushing or crimping damage due to application 6-0 0.049 of surgical instruments such as forceps or needle holders. 5-0 0.033 MONOCRYL suture knots must be properly placed to be secure. Adequate knot 4-0 0.045 security requires the accepted surgical technique of flat and square ties with 3-0 0.067 additional throws as warranted by surgical circumstance and the experience of 2-0 0.055 the surgeon. The use of additional throws may be particularly appropriate 0 0.088 when knotting monofilaments. 1 0.066 Avoid prolonged exposure to elevated temperature. 2 0.099 To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to INDICATIONS the point. Reshaping needles may cause them to lose strength and be less MONOCRYL sutures are indicated for use in general soft tissue approximation resistant to bending and breaking. Users should exercise caution when and/or ligation, but not for use in cardiovascular or neurological tissues, handling surgical needles to avoid inadvertent needle sticks. Discard used microsurgery or ophthalmic surgery. needles in "sharps" containers.

ACTIONS ADVERSE REACTIONS MONOCRYL suture is a monofilament which elicits a minimal acute inflamma- Adverse effects associated with the use of synthetic absorbable sutures include tory reaction in tissues and ingrowth of fibrous connective tissue. Progressive wound dehiscence, failure to provide adequate wound support in closure of the loss of tensile strength and eventual absorption of MONOCRYL sutures occurs sites where expansion, stretching, or distension occur, failure to provide ade- by means of hydrolysis. Absorption begins as a loss of tensile strength quate wound support in elderly, malnourished or debilitated patients or in followed by a loss of mass. Implantation studies in rats indicate that patients suffering from conditions which may delay wound healing, infection, MONOCRYL suture retains approximately 50 to 60% of its original strength minimal acute inflammatory tissue reaction, localized irritation when skin 7 days post implantation, and approximately 20 to 30% of its original tensile sutures are left in place for greater than 7 days, suture extrusion and delayed strength at 14 days post implantation. All of the original tensile strength is lost absorption in tissue with poor blood supply, calculi formation in urinary and by 21 days post implantation. The absolute strength remaining 14 days post biliary tracts when prolonged contact with salt solutions such as urine and bile implantation meets or exceeds that historically observed with plain or chromic occurs, and transitory local irritation at the wound site. Broken needles may surgical gut sutures. Absorption of MONOCRYL absorbable synthetic suture is result in extended or additional surgeries or residual foreign bodies. essentially complete between 91 and 119 days. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. APPROXIMATE % ORIGINAL

DAYS IMPLANTATION STRENGTH REMAINING HOW SUPPLIED 7 DAYS 50 TO 60% MONOCRYL sutures are available as sterile, monofilament, undyed (natural) 14 DAYS 20 TO 30% strands in sizes 6-0 through 2 (metric sizes 0.7-5), in a variety of lengths, with or without needles. CONTRAINDICATIONS MONOCRYL sutures are also available in sizes 3-0 through 1 (metricsizes 2-4) attached to CONTROL RELEASE* removable needles. This suture, being absorbable, should not be used where extended approxi- mation of tissue under stress is required, such as in fascia. MONOCRYL sutures are available in one and three dozen boxes.

WARNINGS Users should be familiar with surgical procedures and techniques involving 389385 *Trademark ©ETHICON, INC. 1995 absorbable sutures before employing MONOCRYL suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture for use in patients. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. Do not resterilize. Discard opened packages and unused sutures.

As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. As an absorbable suture, MONOCRYL suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. 98 PRODUCT INFORMATION

MONOCRYL* VIOLET MONOFILAMENT PRECAUTIONS Skin sutures which must remain in place longer than 7 days may cause local- (Poliglecaprone 25) Suture ized irritation and should be snipped off or removed as indicated. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and SYNTHETIC ABSORBABLE SUTURE, U.S.P., induration normally associated with absorption. EXCEPT FOR DIAMETER Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon. DESCRIPTION Consideration should be taken in the use of absorbable sutures in tissue with MONOCRYL* (poliglecaprone 25) suture is a monofilament synthetic poor blood supply as suture extrusion and delayed absorption may occur. absorbable surgical suture prepared from a copolymer of glycolide and In handling this or any other suture material, care should be taken to avoid epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be damage from handling. Avoid crushing or crimping damage due to application nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during of surgical instruments such as forceps or needle holders. absorption. MONOCRYL suture knots must be properly placed to be secure. Adequate knot MONOCRYL sutures are U.S.P. except for diameters in the following sizes: security requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments. U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) Avoid prolonged exposure to elevated temperature. 6-0 0.049 5-0 0.033 To avoid damaging needle points and swage areas, grasp the needle in an area 4-0 0.045 one-third (1/3) to one-half (1/2) of the distance from the swaged end to the 3-0 0.067 point. Reshaping needles may cause them to lose strength and be less 2-0 0.055 resistant to bending and breaking. Users should exercise caution when 0 0.088 handling surgical needles to avoid inadvertent needle sticks. Discard used 1 0.066 needles in "sharps" containers. 2 0.099 ADVERSE REACTIONS INDICATIONS Adverse effects associated with the use of synthetic absorbable sutures include MONOCRYL sutures are indicated for use in general soft tissue approximation wound dehiscence, failure to provide adequate wound support in closure of the and/or ligation, but not for use in cardiovascular or neurological tissues, sites where expansion, stretching, or distension occur, failure to provide microsurgery or ophthalmic surgery. adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, ACTIONS minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed MONOCRYL suture is a monofilament which elicits a minimal acute inflamma- absorption in tissue with poor blood supply, calculi formation in urinary and tory reaction in tissues and ingrowth of fibrous connective tissue. Progressive biliary tracts when prolonged contact with salt solutions such as urine and bile loss of tensile strength and eventual absorption of MONOCRYL sutures occurs occurs, and transitory local irritation at the wound site. Broken needles may by means of hydrolysis. Absorption begins as a loss of tensile strength result in extended or additional surgeries or residual foreign bodies. followed by a loss of mass. Implantation studies in rats indicate that Inadvertent needle sticks with contaminated surgical needles may result in the MONOCRYL suture retains approximately 60 to 70% of its original strength transmission of bloodborne pathogens. 7 days post implantation, and approximately 30 to 40% of its original tensile strength at 14 days post implantation. Essentially all of the original tensile strength is lost by 28 days post implantation. Absorption of MONOCRYL HOW SUPPLIED absorbable synthetic suture is essentially complete between 91 and 119 days. MONOCRYL sutures are available as sterile, monofilament, dyed (violet) strands in sizes 6-0 through 2 (metric sizes 0.7-5), in a variety of lengths, with APPROXIMATE % ORIGINAL or without needles. MONOCRYL sutures are also available in sizes 3-0 through DAYS IMPLANTATION STRENGTH REMAINING 1 (metric sizes 2-4) attached to CONTROL RELEASE* removable needles. MONOCRYL sutures are available in one and three dozen boxes. 7 DAYS 60 TO 70% 14 DAYS 30 TO 40%

389310 *Trademark © ETHICON, INC. 1996 CONTRAINDICATIONS This suture, being absorbable, should not be used where extended approxi- mation of tissue under stress is required.

WARNINGS Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing MONOCRYL suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture for use in patients. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. As an absorbable suture, MONOCRYL suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require additional support. CHAPTER 8 99

NUROLON* NYLON SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid NONABSORBABLE SURGICAL SUTURE, U.S.P. damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. DESCRIPTION As with any suture material, adequate knot security requires the accepted NUROLON* nylon suture is a nonabsorbable sterile surgical braided suture surgical technique of flat and square ties with additional throws as warranted composed of the long-chain aliphatic polymers Nylon 6 or Nylon 6,6. by surgical circumstance and the experience of the surgeon. NUROLON sutures are dyed black to enhance visibility in tissue. The suture is also available undyed (clear). To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the NUROLON suture meets all requirements established by the United States point. Reshaping needles may cause them to lose strength and be less Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. INDICATIONS NUROLON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ADVERSE REACTIONS ophthalmic and neurological procedures. Adverse effects associated with the use of this device include wound dehiscence, gradual loss of tensile strength over time, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as ACTIONS urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in NUROLON suture elicits a minimal acute inflammatory reaction in extended or additional surgeries or residual foreign bodies. Inadvertent needle tissue, which is followed by a gradual encapsulation of the suture by fibrous sticks with contaminated surgical needles may result in the transmission of connective tissue. While nylon is not absorbed, progressive hydrolysis of the bloodborne pathogens. nylon in vivo may result in gradual loss of tensile strength over time.

HOW SUPPLIED CONTRAINDICATIONS NUROLON sutures are available in U.S.P. sizes 6-0 through 1 (metric sizes Due to the gradual loss of tensile strength which may occur over prolonged 0.7-4.0) in a variety of lengths with and without permanently attached needles. periods in vivo, nylon suture should not be used where permanent retention of tensile strength is required. NUROLON sutures are available in U.S.P. sizes 4-0 through 1 (metric sizes 1.5-4.0) attached to CONTROL RELEASE* removable needles. NUROLON sutures are available in one, two and three dozen boxes. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing NUROLON suture for wound closure, as risk of wound dehiscence may vary with the site of application and the 389354 *Trademark ©ETHICON, INC. 1995 suture material used. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. Acceptable surgical practices should be followed for the management of infected or contaminated wounds. Do not resterilize. Discard opened packages and unused sutures. 100 PRODUCT INFORMATION

PDS* II (POLYDIOXANONE) Suture WARNINGS DYED and CLEAR MONOFILAMENT The safety and effectiveness of PDS II (polydioxanone) sutures have not been established in neural tissue, adult cardiovascular tissue or for use in micro- SYNTHETIC ABSORBABLE SUTURES, U.S.P., surgery. EXCEPT FOR DIAMETER. Under certain circumstances, notably orthopaedic procedures, immobilization by external support may be employed at the discretion of the surgeon. DESCRIPTION Do not resterilize. PDS* II (polydioxanone) monofilament synthetic absorbable suture is prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H603)x. PRECAUTIONS Polydioxanone polymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. The PDS II suture knots must be properly placed to be secure. As with other PDS II sutures are U.S.P., except for diameter. synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator. MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. As with any suture, care should be taken to avoid damage when handling. U.S.P. SUTURE Avoid the crushing or crimping application of surgical instruments, such as SIZE DESIGNATION MAXIMUM OVERSIZE (mm) needle holders and forceps, to the strand except when grasping the free end of 9-0 .005 the suture during an instrument tie. 8-0 .008 7-0 .020 Conjunctival and vaginal mucosal sutures remaining in place for extended 6-0 .015 periods may be associated with localized irritation and should be removed as 5-0 .029 indicated. 4-0 .029 Subcuticular sutures should be placed as deeply as possible in order to 3-0 .056 minimize the erythema and induration normally associated with absorption. 2-0 .029 0 .071 Acceptable surgical practice should be followed with respect to drainage and 1 .047 closure of infected wounds. 2 .023

ADVERSE REACTIONS ACTIONS Due to prolonged suture absorption, some irritation and bleeding has been Two important characteristics describe the in vivo performance of absorbable observed in the conjunctiva and mild irritation has been observed in the sutures: first, tensile strength retention, and second, the absorption rate (loss vaginal mucosa. of mass). PDS II synthetic absorbable suture has been formulated to minimize the variability of these characteristics and to provide wound support through an extended healing period. DOSAGE AND ADMINISTRATION The results of implantation studies of PDS II monofilament suture in animals Use as required per surgical procedure. indicate that approximately 70% of its original strength remains two weeks after implantation. At four weeks post-implantation, approximately 50% of its original strength is retained, and at six weeks, approximately 25% of the origi- nal strength is retained. HOW SUPPLIED Data obtained from implantation studies in rats show that the absorption of PDS II sutures are available as sterile, monofilament dyed (violet) strands in these sutures is minimal until about the 90th post-implantation day. Absorption sizes 9-0 thru 2 (metric sizes 0.3-5), and sterile, monofilament dyed (blue) is essentially complete within six months. strands in size 9-0 thru 7-0 (metric size 0.3-0.5) in a variety of lengths, with a variety of needles. PDS II monofilament dyed (violet) sutures, sizes 4-0 thru 1 (metric size 1.5-4) are INDICATIONS also available attached to CONTROL RELEASE* removable needles. PDS II monofilament synthetic absorbable sutures are indicated for use in all PDS II Clear suture strands are available in sizes 7-0 thru 1 (metric size 0.5-4) in types of soft tissue approximation, including use in pediatric cardiovascular tis- a variety of lengths with permanently attached needles. sue where growth is expected to occur and opthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. 388W91 *Trademark ©ETHICON, INC. 1992

CONTRAINDICATIONS These sutures, being absorbable, are not to be used where prolonged (beyond six weeks) approximation of tissues under stress is required are not to be used in conjunction with prosthetic devices, i.e., heart valves or synthetic grafts. CHAPTER 8 101

PERMA-HAND* SILK SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid NONABSORBABLE SURGICAL SUTURE, U.S.P. damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

DESCRIPTION As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties with additional throws as warranted PERMA-HAND* silk suture is a nonabsorbable, sterile, surgical suture by surgical circumstance and the experience of the surgeon. composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. To avoid damaging needles points and swage areas, grasp the needle in an PERMA-HAND sutures are processed to remove the natural waxes and gums. area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the PERMA-HAND suture is dyed black and coated with a special was mixture. point. Reshaping needles may cause them to lose strength and be less PERMA-HAND suture is also available in its natural color. PERMA-HAND Virgin resistant to bending and breaking g. Users should exercise caution when silk suture is available in which the sericin gum is not removed and serves to handling surgical needles to avoid inadvertent needle sticks. Discard used hold the filaments together. needles in "sharps" containers. PERMA-HAND suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound INDICATIONS dehiscence, gradual loss of all tensile strength over time, allergic response in patients that are know to be sensitive to silk, calculi formation in urinary and PERMA-HAND suture is indicated for use in general soft tissue approximation biliary tracts when prolonged contact with salt solutions such as urine and bile and/or ligation, including use in cardiovascular, ophthalmic and neurological occurs, infection, acute inflammatory tissue reaction, and transitory local procedures. irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne ACTIONS pathogens. PERMA-HAND suture elicits an acute inflammatory reaction in tissue, which is followed by a gradual encapsulation of the suture by fibrous connective tissue. While silk sutures are not absorbed, progressive degradation of the proteina- HOW SUPPLIED ceous silk fiber in vivo may result in gradual loss of all of the suture’s tensile PERMA-HAND sutures are available in U.S.P. sizes 9-0 through 5 (metric sizes strength over time. 0.3-7.0) in a variety of lengths with and without permanently attached needles and on LIGAPAK* dispensing reels.

CONTRAINDICATIONS PERMA-HAND sutures are also available in U.S.P. sizes 4-0 through 1 (metric sizes 1.5-4.0) attached to CONTROL RELEASE* removable needles. The use of this suture is contraindicated in patients with known sensitivities or allergies to silk. PERMA-HAND sutures are available in one, two, and three dozen boxes. Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, silk should not be used where permanent retention of tensile strength is required.

389353 *Trademark ©ETHICON, INC. 1995 WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing PERMA-HAND suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds.

Do not sterilize. Discard opened packages and unused sutures. 102 PRODUCT INFORMATION

PROLENE* POLYPROPYLENE SUTURE ADVERSE REACTIONS Adverse effects associated with the use of this device include wound NONABSORBABLE SURGICAL SUTURE, U.S.P. dehiscence, calculi formation in urinary and biliary tracts when prolonged Except for size 7-0 diameter contact with salt solutions such as urine and bile occurs, infection, minimal and HEMO-SEAL* Needle Suture Attachment acute inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles DESCRIPTION may result in the transmission of bloodborne pathogens. PROLENE* polypropylene suture (clear or pigmented) is a nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The suture is pigmented blue to HOW SUPPLIED enhance visibility. PROLENE sutures, pigmented, are available as sterile strands in U.S.P. sizes Size 7-0 PROLENE sutures are U.S.P., except for diameter. 10-0 through 8-0 (metric sizes 0.2-0.4) and 6-0 through 2 (metric sizes 0.7-5.0). PROLENE sutures, clear, are available as sterile strands in U.S.P. sizes 6-0 MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. through 2 (metric sizes 0.7-5.0). Size 7-0 (metric size 0.5) PROLENE sutures, pig- mented and clear are U.S.P. except for diameter. All PROLENE sutures are avail- U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) able in a variety of lengths, with permanently attached needles. 7-0 .007 PROLENE sutures, pigmented and clear are also available as sterile strands in U.S.P. sizes 0 through 2 (metric sizes 3.5-5.0) attached to CONTROL RELEASE* PROLENE suture, available as HEMO-SEAL* needle suture, is a needle suture removable needles. combination in which the diameter of the needle swage area has been reduced to facilitate attachment of finer wire diameter needles. The diameter of the PROLENE sutures, pigmented and clear are also available as sterile strands in suture strand and the needle wire have been more closely aligned to reduce the U.S.P. sizes 0 through 5-0, attached to TFE pledgets measuring 1/4" x 1/8" x degree of needle hole bleeding. HEMO-SEAL needle suture differs from U.S.P. 1/16" (7.0mm x 3.0mm x 1.5mm). in needle attachment requirements only. PROLENE sutures, pigmented and clear are also available in sterile strands as HEMO-SEAL* needle sutures in the following sizes:

INDICATIONS PROLENE Suture HEMO-SEAL HEMO-SEAL Needle Suture Limits PROLENE suture is indicated for use in general soft tissue approximation U.S.P. Size Needle Suture on Needle Attachment and/or ligation, including use in cardiovascular, ophthalmic and neurological Avg. (Kgf) Individual (Kgf) procedures. Min. Min. 5-0 HS-7 0.17 0.08 ACTIONS 4-0 HS-6 0.23 0.11 PROLENE suture elicits a minimal acute inflammatory reaction in tissue, which 3-0 HS-5 0.45 0.23 is followed by gradual encapsulation of the suture by fibrous connective tissue. PROLENE suture is not absorbed, nor is it subject to degradation or weakening USP Limits on Needle Attachment by the action of tissue enzymes. As a monofilament, PROLENE suture, U.S.P. resists involvement in infection and has been successfully employed in con- Avg. (Kgf) Individual (Kgf) taminated and infected wounds to eliminate or minimize later sinus formation U.S.P. Size Min. Min. and suture extrusion. The lack of adherence to tissues has facilitated the use of 5-0 0.23 0.11 PROLENE suture as a pull-out suture. 4-0 0.45 0.23 3-0 0.68 0.34 CONTRAINDICATIONS None known. PROLENE sutures are available in one, two, and three dozen boxes.

WARNINGS Users should be familiar with surgical procedures and techniques involving 389361 *Trademark ©ETHICON, INC. 1995 nonabsorbable sutures before employing PROLENE suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. Acceptable surgical practice must be followed for the management of infected or contaminated wounds.

PRECAUTIONS In handling this suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Adequate knot security requires the accepted surgical technique of flat, square ties of single suture strands. The use of additional throws is particularly appro- priate when knotting polypropylene sutures. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resist- ant to bending and breaking. Users should exercise caution when handling sur- gical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. CHAPTER 8 103

PROLENE* (POLYPROPYLENE) INSTRUCTIONS FOR USE For indirect hernia, a high dissection of the neck of the hernia sac to utilize the HERNIA SYSTEM potential of the preperitoneal space can be performed to insert the PROLENE Hernia System. The circular or bottom underlay portion of the PROLENE Hernia Nonabsorbable Synthetic Surgical Mesh System is folded and is inserted through the internal ring allowing the mesh to expand to the underlay position. Surgical manipulation may be used to facilitate the expansion of the device to the underlay position. No sutures are DESCRIPTION necessary in the bottom underlay patch. The top onlay patch, which is The PROLENE* (Polypropylene) Hernia System is a sterile, pre-shaped, three designed to cover the posterior wall (floor of the canal), is then modified as dimensional device constructed of an onlay patch connected by a mesh needed to accommodate the cord structures. If one end of the oval onlay patch cylinder to a circular underlay patch. The material is undyed PROLENE* is longer than the other, the PROLENE Hernia System is positioned so that the (Polypropylene) MESH constructed of knitted nonabsorbable polypropylene longer end covers the posterior wall (floor of the canal) and overlaps the filaments. public tubercle. For direct hernia, the defect is circumscribed at its base, the contents fully reduced, and the preperitoneal space is actualized prior to the insertion of the ACTIONS/PERFORMANCE PROLENE Hernia System. The circular or bottom underlay portion of the The PROLENE Hernia System is a nonabsorbable mesh used to reinforce or PROLENE Hernia System is folded and is inserted through the defect or the bridge inguinal hernia deficiencies to provide extended support during and internal ring allowing the mesh to expand to the underlay position. The following wound healing. Animal studies show that implantation of PROLENE underlay portion should expand under the defect in the floor of the canal. Mesh elicits a minimum to slight inflammatory reaction, which is transient and is Surgical manipulation may be used to facilitate the expansion of the device to followed by the deposition of a thin fibrous layer of tissue which can grow the underlay position. Sutures or clips may be used to secure the top onlay through the interstices of the mesh, thus incorporating the mesh into adjacent patch in place. tissue. The mesh remains soft and pliable, and normal wound healing is not noticeably impaired. The material is neither absorbed nor is it subject to degradation or weakening by the action of tissue enzymes. STERILITY The PROLENE Hernia System is sterilized by Ethylene Oxide. Do not resterilize. Do not use if package is opened or damaged. Discard open, unused product. INDICATIONS This product is indicated for the repair of indirect and direct inguinal hernia defects. STORAGE Recommended storage conditions: below 25°C, 77°F, away from moisture and direct heat. Do not use after expiry date. WARNINGS The PROLENE Hernia System is provided by ETHICON, INC. as a sterile product. This device is for single use only. Do not resterilize. Discard opened HOW SUPPLIED packages and unused product. The PROLENE Hernia System is available sterile, undyed in several sizes. When this device is used in infants or children with future growth potential, the surgeon should be aware that this product will not stretch significantly as the patient grows. CAUTION The PROLENE Hernia System should only be used in contaminated wounds Federal (U.S.A.) Law restricts this device to sale by or on the order of a with the understanding that subsequent infection may require removal of the physician. device.

* Trademark ©ETHICON, INC. 1997 PRECAUTIONS Sutures or clips, if necessary, should be placed such that a minimum of 6.5 mm (1/4") of mesh should extend beyond the suture line.

ADVERSE REACTIONS Potential adverse reactions are those typically associated with surgically implantable materials which include infection potentiation, inflammation, adhesion formation, fistula formation and extrusion. 104 PRODUCT INFORMATION

PROLENE* POLYPROPYLENE MESH PRECAUTIONS NONABSORBABLE SYNTHETIC SURGICAL MESH A minimum of 6.5mm (1/4") of mesh should extend beyond the suture line. STERILE ADVERSE REACTIONS DESCRIPTION Potential adverse reactions are those typically associated with surgically implantable materials which include infection potentiation, inflammation, PROLENE* polypropylene mesh is constructed of knitted filaments of extruded adhesion formation, fistula formation and extrusion. polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.020 inches thick. This material, when used INSTRUCTIONS FOR USE as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. It is recommended that nonabsorbable sutures be placed 6.5mm to 12.5mm (1/4" to 1/2") apart at a distance approximately 6.5mm (1/4") from edge of the PROLENE mesh is knitted by a process which interlinks each fiber junction and mesh. Some surgeons prefer to suture an uncut section of mesh that is which provides for elasticity in both directions. This construction permits the considerably larger than the defect into position over the wound. The opposite mesh to be cut into any desired shape or size without unraveling. The fiber sides are then sutured to assure proper closure under correct tension. When junctions are not subject to the same work fatigue exhibited by more rigid the margin sutures have all been placed, the extra mesh is trimmed away. metallic meshes. This bi-directional elastic property allows adaption to various stresses encountered in the body. HOW SUPPLIED ACTIONS PROLENE mesh is available in single packets as sterile, undyed (clear) sheets in seven sizes. The sizes available are 2.5cm x 10cm (1" x 4"), 4.6cm x 10.2cm PROLENE mesh is a nonabsorbable mesh used to span and reinforce traumat- (1.8" x 4"), 6cm x 11cm (2.5" x 4.5"), 6.1cm x 13.7cm (2.4" x 5.4"), 7.6cm x 12.7cm ic or surgical wounds to provide extended support during and following wound (3" x 5"), 15cm x 15cm (6" x 6") and 30cm x 30cm (12" x 12"). Each sheet is healing. Animal studies show that implantation of PROLENE mesh elicits a approximately 0.5mm (0.020") thick. minimum to slight inflammatory reaction, which is transient and is followed by the deposition of a thin fibrous layer of tissue which can grow through the interstices of the mesh, thus incorporating the mesh into adjacent tissue. The mesh remains soft and pliable, and normal wound healing is not noticeably 389392.R01 *Trademark ©ETHICON, INC. 1996 impaired. The material is not absorbed nor is it subject to degradation or weakening by the action of tissue enzymes.

INDICATIONS This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

CONTRAINDICATIONS When this mesh is used in infants or children with future growth potential, the surgeon should be aware that this product will not stretch significantly as the patient grows.

PROLENE mesh in contaminated wounds should be used with the understand- ing that subsequent infection may require removal of the material.

WARNINGS PROLENE mesh is provided by ETHICON, INC. as a sterile product. Resterilization of the device is NOT recommended. However, testing has demonstrated that reprocessing of unused PROLENE mesh which has been removed from the package will not be adversely affected when exposed not more than one time to conventional steam autoclave conditions of 250° F (121° C) for 20 minutes. Reprocessing under any other condition or by any other means is neither recommended nor endorsed by ETHICON, INC. PROLENE mesh should not be flash autoclaved.

If this product should become stained with blood or soiled, it should not be resterilized for reuse.

When reprocessed as outlined above, it is the responsibility of the end-user to assure sterility of the product via a validated sterilization process as ETHICON, INC. has no control over environmental conditions the product may encounter prior to - during - or after reprocessing. CHAPTER 8 105

PRONOVA* POLY (HEXAFLUOROPROPY- PRECAUTIONS In handling this suture material, care should be taken to avoid damage from LENE-VDF) SUTURE handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. NONABSORBABLE SURGICAL SUTURE, U.S.P. Adequate knot security requires the accepted surgical technique of flat, square EXCEPT FOR SIZE 7-0 DIAMETER ties of single suture strands. The use of additional throws is particularly appropriate when knotting monofilament sutures. DESCRIPTION To avoid damaging needle points and swage areas, grasp the needle in an area PRONOVA* suture (clear or pigmented) is a nonabsorbable, sterile surgical one-third (1/3) to one-half (1/2) of the distance from the swaged end to the suture made from a polymer blend of poly(vinylidene fluoride) and poly point. Reshaping needles may cause them to lose strength and be less (vinylidene fluoride-co-hexafluoropropylene). The suture is pigmented blue to resistant to bending and breaking. Users should exercise caution when enhance visibility. handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. Size 7-0 PRONOVA sutures are U.S.P., except for diameter.

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehis- U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) cence, calculi formation in urinary and biliary tracts when prolonged contact 7-0 .007 with salt solutions such as urine and bile occurs, infection, minimal to mild inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual for- INDICATIONS eign bodies. Inadvertent needle sticks with contaminated surgical needles may PRONOVA suture is indicated for use in general soft tissue approximation result in the transmission of bloodborne pathogens. and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. HOW SUPPLIED PRONOVA sutures, pigmented, are available as sterile strands in U.S.P. sizes ACTIONS 10-0 through 8-0 (metric sizes 0.2-0.4) and 6-0 through 2 (metric sizes 0.7-5.0). PRONOVA suture elicits a minimal to mild inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective PRONOVA sutures, clear, are available as sterile strands in U.S.P. sizes 6-0 tissue. PRONOVA suture is not absorbed, nor is it subject to degradation or through 2 (metric sizes 0.7-5.0). Size 7-0 (metric size 0.5) PRONOVA sutures, weakening by the action of tissue enzymes. As a monofilament, PRONOVA pigmented and clear are U.S.P. except for diameter. All PRONOVA sutures are suture, U.S.P. resists involvement in infection and has been successfully available in a variety of lengths, with permanently attached needles. employed in contaminated and infected wounds to eliminate or minimize later PRONOVA sutures, pigmented and clear are also available as sterile strands in sinus formation and suture extrusion. Furthermore, the lack of adherence to U.S.P. sizes 0 through 2 (metric sizes 3.5-5.0) attached to CONTROL RELEASE* tissues has facilitated the use of PRONOVA suture as a pull-out suture. removable needles.

PRONOVA sutures are available in one, two, and three dozen boxes. CONTRAINDICATIONS None known.

389556 *Trademark ©ETHICON, INC. 1998 WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing PRONOVA suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. Acceptable surgical practice must be followed for the management of infected or contaminated wounds. 106 PRODUCT INFORMATION

PROXIMATE® SKIN STAPLER

INDICATIONS The Skin Stapler has application for routine skin closure in a wide variety of surgical procedures.

CONTRAINDICATIONS When it is not possible to maintain at least a 5 mm distance from the stapled skin to underlying bones, vessels, or internal organs, the use of staples for skin closure is contraindicated.

DEVICE DESCRIPTION The Skin Stapler is a sterile, single patient use instrument designed to deliver rectangular, stainless steel staples for routine wound closure.

INSTRUCTIONS FOR USE Verify compatibility of all instruments and accessories prior to using the instrument.

1 Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the instrument into the sterile field. 2 Suggested Eversion Techniques: With two tissue forceps, pick up each wound edge individually and approximate the edges (Illustration 1). Or, with one tissue forceps, pull skin edges together until edges evert (Illustration 2). Or, apply tension to either end of the incision, such that the tissue edges begin to approximate themselves. One forceps can be used to ensure that the edges are everted (Illustration 3). 3 Position the instrument with moderate pressure over the everted skin edges. The instrument should be held at a 60° angle to the skin (Illustration 4). 4 Squeeze the trigger until the trigger motion is halted, then release the trigger and move the instrument off the incision in any direction (Illustration 5). Alternate Release: If desired, before releasing the trigger lift up on the instrument. This will help to evert the skin edges, which can then be more easily grasped with the tissue forceps. Release the trigger after the forceps are in place, and repeat the sequence to fire the next staple. (Illustration 6) Alternate Technique: The instrument can also be precocked (partially fired) so that the staple points are visible at the nose of the instrument. This feature, in conjunction with the clear nose and alignment arrow, ensures precise staple placement in the skin (Illustration 7). Note: If desired, after the instrument has been precocked, one leg of the staple can be hooked onto one side of the tissue. This will aid in drawing the tissue together. This technique may be suitable for attaching skin grafts under moderate tension (Illustration 8).

WARNINGS AND PRECAUTIONS • Dispose of all opened products whether used or unused. Do Not Resterilize the instrument. Resterilization may compromise the integrity of the instrument which may result in unintended injury.

HOW SUPPLIED The PROXIMATE Skin Stapler is supplied sterile and preloaded for single patient use. Discard after use.

FORMED STAPLE DIMENSIONS Regular staples have an approximate diameter of 0.53 mm, span of 5.7 mm, and leg length of 3.9 mm. Wide staples have an approximate diameter of 0.58 mm, span of 6.9 mm, and leg length of 3.9 mm.

P40334P02 *Trademark ©ETHICON ENDO-SURGERY, INC. 1999 CHAPTER 8 107

PROXIMATE® SKIN STAPLER EXTRACTOR

INDICATIONS The PROXIMATE Skin Staple Extractor has application for routine skin closure in a wide variety of surgical procedures.

CONTRAINDICATIONS When it is not possible to maintain at least a 5 mm distance from the stapled skin to underlying bones, vessels, or internal organs, the use of staples for skin closure is contraindicated.

DEVICE DESCRIPTION The PROXIMATE Skin Staple Extractor is a sterile, single patient use, stainless steel device specifically designed to completely open skin staples for removal. The function of the Skin Staple Extractor is to remove Proximate Regular or Wide Skin Staples from skin wounds.

Illustration and Nomenclature 1. Safety Cap 2. Jaws 3. Upper Handle 4. Lower Handle

INSTRUCTIONS FOR USE Verify compatibility of all instruments and accessories prior to using the device.

1 Using sterile technique, remove the device from the package. To avoid damage, do not flip the device into the sterile field. 2 Remove the safety cap from the device. 3 Slide lower jaw of extractor under regular or wide staple until staple is secured in slot in lower jaw. (Illustration 1) 4 Squeeze down with thumb to open staple until handles are firmly touching. (Illustration 2) 5 Ensure staple is completely opened before lifting extractor from skin. Never pull up before extractor is fully closed. (Illustration 3)

Warnings and Precautions • Dispose of all opened products whether used or unused. Do Not Resterilize the device. Resterilization may compromise the integrity of the device which may result in unintended injury.

• Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological contamination.

HOW SUPPLIED The PROXIMATE Skin Staple Extractor is supplied sterile for single patient use. Discard after use.

P40184P05 *Trademark ©ETHICON ENDO-SURGERY, INC. 2001 108 PRODUCT INFORMATION

PROXIMATE® PLUS MD MULTI-DIMENTIONAL RELEASE SKIN STAPLER

INDICATIONS The PROXIMATE PLUS MD Skin Stapler has application for routine skin closure in a wide variety of surgical procedures.

CONTRAINDICATIONS When it is not possible to maintain at least a 5 mm distance from the stapled skin to underlying bones, vessels, or internal organs, the use of staples for skin closure is contraindicated.

DEVICE DESCRIPTION The PROXIMATE PLUS MD Skin Stapler is a sterile, single patient use instrument designed to deliver rectangular, stainless steel staples for routine wound closure.

INSTRUCTIONS FOR USE Verify compatibility of all instruments and accessories prior to using the instru- ment (refer to Warnings and Precautions).

1 Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the instrument into the sterile field. 2 Evert and approximate skin edges as desired. Several techniques are suggested: a) With one tissue forcep, pull skin edges together until edges evert. (Illustration 1) OR b) With two tissue forceps, pick up each wound edge individually and approximate the edges. (Illustration 2) OR c) Apply tension to either end of the incision, such that the tissue edges begin to approximate themselves. One forcep can be used to ensure that the edges are everted. 3 Position the instrument over the everted skin edges, aligning the instrument arrow with the incision. (Illustration 3) 4 Squeeze the trigger until the trigger motion is halted. Release the trigger and remove the instrument from the fired staple. (Illustration 4)

WARNINGS AND PRECAUTIONS • Dispose of all opened instruments, whether used or unused. Do Not Resterilize the instrument. Resterilization may compromise the integrity of the stapler which may result in unintended injury.

HOW SUPPLIED The PROXIMATE PLUS MD Skin Stapler is supplied sterile and preloaded for single patient use. Discard after use.

FORMED STAPLE DIMENSIONS Regular staples have a diameter of 0.53 mm, a span of 5.7 mm, and a leg length of 3.9 mm. Wide staples have a diameter of 0.58 mm, a span of 6.9 mm, and a leg length of 3.9 mm.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

P40225P04 *Trademark ©ETHICON ENDO-SURGERY, INC. 1996 CHAPTER 8 109

SURGICAL GUT SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid ABSORBABLE SURGICAL SUTURES, U.S.P. damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Surgical gut sutures require the accepted surgical technique of flat and square ties with DESCRIPTION additional throws as warranted by surgical circumstance and the experience of Surgical gut suture is an absorbable, sterile surgical suture composed of the surgeon. purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) Under some circumstances, notably orthopaedic procedures, immobilization of intestines. Surgical gut sutures are available in plain or chromic. Chromic gut joints by external support may be employed at the discretion of the surgeon. is processed to provide greater resistance to absorption. Surgical gut is The surgeon should avoid unnecessary tension when running down knots, to packaged in tubing fluid. Blue dyed chromic gut suture is also available. reduce the occurrence of surface fraying and weakening of the strand. Surgical gut suture meets all requirements established by the United States Avoid prolonged exposure to elevated temperatures. Pharmacopoeia (U.S.P.) for absorbable surgical sutures. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the INDICATIONS point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when Surgical gut suture is indicated for use in general soft tissue approximation handling surgical needles to avoid inadvertent needle sticks. Discard used and/or ligation, including use in ophthalmic procedures, but not for use in needles in "sharps" containers. cardiovascular and neurological tissues.

ADVERSE REACTIONS ACTIONS Adverse effects associated with the use of this device include wound dehis- When surgical gut suture is placed in tissue, a moderate tissue inflammation cence, variable rates of absorption over time (depending on such factors as the occurs which is characteristic of foreign body response to a substance. This is type of suture used, the presence of infection and the tissue site), failure to pro- followed by a loss of tensile strength and a loss of suture mass, as the prote- vide adequate wound support in closure of sites where expansion, stretching olytic enzymatic digestive process dissolves the surgical gut. This process or distension occur, etc., unless additional support is supplied through the use continues until the suture is completely absorbed. Many variable factors may of nonabsorbable suture material, failure to provide adequate wound support affect the rate of absorption. Some of the major factors which can affect tensile in elderly, malnourished or debilitated patients or in patients suffering from strength loss and absorption rates are: cancer, anemia, obesity, diabetes, infection or other conditions which may 1. Type of suture - plain gut generally absorbs more rapidly than chromic gut. delay wound healing, allergic response in patients with known sensitivities to collagen or chromium which may result in an immunological reaction resulting 2. Infection - surgical gut is absorbed more rapidly in infected tissue in inflammation, tissue granulation or fibrosis, wound suppuration and bleed- than in non-infected tissue. ing, as well as sinus formation, infection, moderate tissue inflammatory response characteristic of foreign body response, calculi formation in urinary 3. Tissue sites - surgical gut will absorb more rapidly in tissue where and biliary tracts when prolonged contact with salt solutions such as urine and increased levels of proteolytic enzymes are present, as in the secre- bile occurs, and transitory local irritation at the wound site. Broken needles tions exhibited in the stomach, cervix and vagina. may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. CONTRAINDICATIONS This suture, being absorbable, should not be used where extended approxi- mation of tissue is required. HOW SUPPLIED Surgical gut sutures are available in U.S.P. sizes 7-0 through 3 (metric sizes The use of this suture is contraindicated in patients with known sensitivities or 0.7-7.0) in a variety of lengths with and without permanently attached needles allergies to collagen or chromium, as gut is a collagen based material, and and on LIGAPAK* dispensing reels. Surgical gut sutures are also available in chromic gut is treated with chromic salt solutions. U.S.P. sizes 0 through 1 (metric sizes 4.0-5.0) attached to CONTROL RELEASE* removable needles. The suture is supplied sterile in one, two and three WARNINGS dozen boxes. Users should be familiar with surgical procedures and techniques involving gut suture before using surgical gut suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. 389360 *Trademark ©ETHICON, INC. 1995 Physicians should consider the in vivo performance when selecting a suture. The use of this suture may be inappropriate in elderly, malnourished, or debil- itated patients, or in patients suffering from conditions which may delay wound healing. As this is an absorbable material, the use of supplemental non- absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus for- mation. As an absorbable suture, surgical gut may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. Do not resterilize. Discard open packages and unused sutures. Certain patients may be hypersensitive to collagen or chromium and might exhibit an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation. 110 PRODUCT INFORMATION

SURGICAL STAINLESS STEEL SUTURE PRECAUTIONS In handling this or any other suture material, care should be taken to avoid NONABSORBABLE SURGICAL SUTURES, U.S.P. damage from handling, such as kinking or excessive twisting.

To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the DESCRIPTION point. Reshaping needles may cause them to lose strength and be less Surgical stainless steel suture is a nonabsorbable, sterile surgical suture resistant to bending and breaking. Users should exercise caution when composed of 316L stainless steel. Surgical stainless steel suture is available as handling surgical needles to avoid inadvertent needle sticks. Discard used a monofilament and multifilament suture. needles in "sharps" containers.

Surgical stainless steel suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical sutures. Surgical ADVERSE REACTIONS stainless steel suture is also labeled with the B&S gauge classifications. Adverse effects associated with the use of this device include wound dehis- cence, allergic response in patients with known sensitivities to 316L stainless INDICATIONS steel, or constituent metals such as chromium and nickel, infection, minimal acute inflammatory tissue reaction, pain, edema and local irritation at the Surgical stainless steel suture is indicated for use in abdominal wound closure, wound site. Broken needles may result in extended or additional surgeries or hernia repair, sternal closure and orthopaedic procedures including cerclage residual foreign bodies. Inadvertent needle sticks with contaminated surgical and tendon repair. needles may result in the transmission of bloodborne pathogens.

ACTIONS HOW SUPPLIED Surgical stainless steel suture elicits a minimal acute inflammatory reaction in Surgical stainless steel sutures are available in sizes 7 through 10-0 (metric tissue and is not absorbed. sizes 9.0-0.2) in a variety of lengths with and without permanently attached needles in one, two and three dozen boxes. CONTRAINDICATIONS The use of this suture is contraindicated in patients with known sensitivities or allergies to 316L stainless steel, or constituent metals such as chromium and 389357 *Trademark ©ETHICON, INC. 1995 nickel.

WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable, stainless steel sutures before employing for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed for the management of contam- inated or infected wounds. CHAPTER 8 111

VICRYL* Knitted Mesh WARNINGS DO NOT RESTERILIZE. The safety and effectiveness of VICRYL knitted mesh in neural tissue and in car- DESCRIPTION diovascular tissue has not been established. VICRYL* (polyglactin 910) knitted mesh is prepared from a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic and lactic acids. This knitted mesh is prepared from uncoated, undyed fiber identical in PRECAUTIONS composition to that used in VICRYL (polyglactin 910) synthetic absorbable None. suture, which has been found to be inert, nonantigenic, nonpyrogenic and to elicit only a mild tissue reaction during absorption. ADVERSE REACTIONS VICRYL knitted mesh is intended for use as a buttress to provide temporary sup- No significant clinical adverse reactions to the mesh have been reported. port during the healing process.

DIRECTIONS FOR USE ACTIONS It is recommended that absorbable or nonabsorbable sutures by placed 1/4 to Two important characteristics describe the in vivo function and behavior of 1/2 inch (6 to 12mm) apart at a distance approximately 1/4 inch (6mm) form the VICRYL knitted mesh: reinforced wound strength and the rate of absorption edge of the mesh. Some surgeons prefer to suture a mesh larger than the (loss of mass). defect into position over the defect. The edges are then sutured to assure a The dehiscence force of healing abdominal wounds in rats closed with size 4-0 proper closure under correct tension. When all margin sutures have been absorbable sutures was compared with corresponding wounds closed with size placed, the excess mesh is trimmed away, leaving at least 1/4 inch of mesh 4-0 absorbable sutures and reinforced with VICRYL knitted mesh. In this animal extending beyond the suture line. model, the strength of the incision, when supported by the mesh, was signifi- cantly greater than the sutured incisional wound. Explanted VICRYL knitted mesh, which, before implantation had an initial average burst strength of 63 HOW SUPPLIED lbs., was found to have 80% of its original burst strength remaining after VICRYL knitted mesh is available in single packets as a sterile, undyed fabric fourteen days in vivo. mesh in single sheet sizes of approximately 6 x 6 inches and 12 x 12 inches Subcutaneous implantation studies in rats indicate that the absorption of (15 x 15 centimeters and 30 x 30 centimeters). VICRYL mesh material is minimal until about six weeks post implantation and essentially complete between 60 and 90 days.

389096 *Trademark ©ETHICON, INC. 1986 INDICATIONS VICRYL knitted mesh may be used wherever temporary wound or organ sup- port is required, particularly in instances in which compliant and stretchable support material is desired and containment of wound transudate is not required. VICRYL knitted mesh may be cut to the shape or size desired for each specific application.

CONTRAINDICATIONS Because VICRYL knitted mesh is absorbable, it should not be used where extended wound or organ support is required. 112 PRODUCT INFORMATION

VICRYL* Woven Mesh WARNINGS DO NOT RESTERILIZE. The safety and effectiveness of VICRYL woven mesh in neural tissue and in car- DESCRIPTION diovascular tissue has not been established. VICRYL* (polyglactin 910) woven mesh is prepared from a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic and lactic acids. This tightly woven mesh is prepared from uncoated, undyed fiber PRECAUTIONS identical in composition to that used in VICRYL* (polyglactin 910) synthetic None. absorbable suture, which has been found to be inert, nonantigenic, nonpyro- genic and to elicit only a mild tissue reaction during absorption. VICRYL woven mesh is intended for use as a buttress to provide temporary sup- ADVERSE REACTIONS port during the healing process. None known.

ACTIONS DIRECTIONS FOR USE Two important characteristics describe the in vivo function and behavior of It is recommended that absorbable or nonabsorbable sutures be placed 1/4 to VICRYL woven mesh: reinforced wound strength and the rate of absorption 1/2 inch (6 to 12mm) apart at a distance at least 1/4 inch (6mm) from the edge (loss of mass). of the mesh. Some surgeons prefer to suture a mesh larger than the defect into position over the defect. The edges are then sutured to assure proper closure The dehiscence force of healing abdominal wounds in rats closed with size 4-0 under correct tension. When all margin sutures have been placed, the excess absorbable sutures was compared with corresponding wounds closed with size mesh is trimmed away, leaving at least 1/4 inch of mesh extending beyond the 4-0 absorbable sutures and reinforced with VICRYL woven mesh. In this animal suture line. model, the strength of the incision, when supported by the mesh, was signifi- cantly greater than the sutured incisional wound. Explanted VICRYL woven mesh, which, before implantation had an initial average burst strength of HOW SUPPLIED approximately 121 lbs., was found to have approximately 23% of its original VICRYL woven mesh is available in single packets as a sterile, undyed, fabric burst strength remaining after fourteen days in vivo. mesh in single sheet sizes of approximately 6 x 6 inches and 12 x 12 inches Subcutaneous implantation studies in rats indicate that the absorption of (15 x 15 centimeters and 30 x 30 centimeters). VICRYL mesh material is minimal until about six weeks post implantation and essentially complete between 60 and 90 days.

INDICATIONS 389065 *Trademark ©ETHICON, INC. 1986 VICRYL woven mesh may be used wherever temporary wound or organ support is required. The woven mesh structure is less porous than VICRYL knitted mesh. It is indicated in instances in which containment of wound transudate is desirable. VICRYL woven mesh may be cut to the shape or size desired for each specific application.

CONTRAINDICATIONS Because VICRYL woven mesh is absorbable, it should not be used where extended wound or organ support is required. CHAPTER 9

INDEX 114 INDEX

COATED VICRYL RAPIDE* (POLYGLACTIN 910) SUTURE, 14, ABDOMEN, 23, 26, 28, 30 A 32-33, 39, 90 abdominal cavity, 23, 26, 30, 34, 50, 63 abdominal wall, 16, 19, 23, 28, DEAD SPACE, 5, 22, 32, 81 30-31, 33-34, 44, 77, 82, 84 D DERMABOND* fascia, 2, 5, 21, 30-32, 34, 39-40, TOPICAL SKIN ADHESIVE 47-48, 50-51, 63, 77, 82, 96 (2-OCTYL CYANOACRYLATE), 68-71, muscle tissue, 2, 30 81, 91-92 peritoneum, 19, 23, 29-31, 34, DISSECTION, 4, 48, 103 47-48, 50, 63 skin, 2, 31-33 subcutaneous fat, 30-32, 47-48 ETHIBOND* EXCEL POLYESTER subcuticular tissue, 32 E SUTURE, 10, 17-18, 20, 25, 33, 37-38, transversalis fascia, 30 58-59, 81, 83, 93 ALIMENTARY TRACT, 35 ETHILON* NYLON SUTURE, 10, 17, 20, esophagus, 36 25, 33-36, 58-59, 81, 94 oral cavity, 35-36, 47-48, 69, 89 EYE, 35-36 pharynx, 35, 47-48 conjunctiva, 35-36, 100 upper alimentary tract, 35 cornea, 35-36, 80 ocular muscles, 35-36 sclera, 35-36 B BILIARY TRACT, 6, 29, 38, 47-48 gallbladder, 29 BONE, 2, 16, 39-40, 80 FEMALE GENITAL TRACT, 38 anchor, 18, 39, 65 F sternum, 39 BRAIN, 34 cerebrospinal fluid, 34 GASTROINTESTINAL TRACT, 6, 28-29, dura mater, 34-35 G 46-48 galea, 34, 76 colon, 2, 27, 29 peripheral nerve repair, 34 rectum, 29 skull, 35 small intestine, 2, 28-29, 94 stomach, 2-3, 27-29, 81, 94, 110

C CARDIOVASCULAR SURGERY, 18, 37, 45, 51, 83 HIGH VISCOSITY DERMABOND* heart valves, 21, 38, 99 H TOPICAL SKIN ADHESIVE pledgets, 18, 21, 38, 91, 101 (2-OCTYL CYANOACRYLATE), 69, sternum, 16, 37, 39, 44, 48 91-92 COATED VICRYL* (POLYGLACTIN 910) SUTURE, 15, 25, I INCISION, 4-6, 24, 28, 30-32, 48, 59, 62, 88, 111 68 COATED VICRYL* PLUS INFLAMMATORY RESPONSE, 6-7, 77, (POLYGLACTIN 910) SUTURE, 10, 12, 94, 110 26, 28, 38, 58, 80, 89 CHAPTER 9 115

K KNOT SECURITY, 11, 15, 24, 92-93, 95, N NECROTIC TISSUE, 4, 40 97-103, 105 NEEDLE, 10, 42-54 KNOT TENSILE STRENGTH, 11, 89 anatomy, 44 KNOT TYING, 17, 23-26, 34, 65, 94 body, 43-54 endoscopic, 25-26, 38, 51 eye, 44-46 monofilament sutures, 11, 18, point, 42-44, 46, 48-49 24, 29, 32-33, 35, 37, 95, applications, 47-48 105 shape, 45-50 multifilament sutures, 11, 24, 29, compound curved, 47 31-33, 36 curved, 46-47 techniques, 18, 25-26 half-curved, 46-47 deep tie, 25-26 ski, 46 instrument tie, 24-26 straight, 46-47 square knot, 25-26 Bunnell, 46, 51 surgeon’s knot, 25-26 Keith, 46, 51 sharpness, 43, 47-50, 53, 82 stability, 43, 48 L LIGATURES, 10, 18-19, 28, 62, 85 strength, 42 free tie, 18-19, 28 ETHALLOY* needle alloy, LIGAPAK* dispensing reel, 21, 42, 81 59, 63, 82, 101, 110 swage, 44-45, 65, 83 stick tie, 18-19, 85 CONTROL RELEASE* needle, 21, 45, 59, 80 types, 47-51 M MERSILENE* blunt point, 51 POLYESTER FIBER MESH, 82, 97 ETHIGUARD* blunt MERSILENE* point needle, 51, 81 POLYESTER FIBER STRIP, 75, 82 cutting, 43, 46-49, 51 MERSILENE* conventional cutting, POLYESTER FIBER SUTURE, 13, 17, 20, 47-49, 83 25, 33, 35, 58-59, 82, 96 PC PRIME* needle, MESH, 30, 35, 82, 84, 86, 96 48, 83 See also MERSILENE* polyester sternotomy, 48-49 fiber mesh; PROLENE* reverse cutting, 48-50, 75, Polypropylene Hernia System; 84 PROLENE* polypropylene mesh; MICRO-POINT* VICRYL* (polyglactin 910) needle, 48-49, 82 knitted mesh; VICRYL* OS, 49, 51 (polyglactin 910) periodontal side-cutting, 48-49, 82 mesh; VICRYL* (polyglactin 910) CS ULTIMA* woven mesh needle, 48, 50, 80 MICROSURGERY, 15, 21, 34, 44, 47-48, SABRELOC* 62, 65, 82, 97-98, 100 needle, 50, 84 MONOCRYL* (POLIGLECAPRONE 25) spatula, 48-51, 82 SUTURE, 10, 12, 14-15, 20, 25, 32, 38, TG PLUS* needle, 58-59, 70-71, 83, 98 50 * Trademark 116 INDEX

taper point, 21, 43, 45-46, purse-string sutures, 19, 22 50-51, 77, 85 running stitches, 19 MAYO, 50-51 subcuticular sutures, 19, 22, TAPERCUT, 43, 48, 50-51 32, 90 TAPERCUT needle, PROLENE* POLYPROPYLENE HERNIA 43, 48, 50-51, SYSTEM, 30, 70, 84, 104 85 PROLENE* POLYPROPYLENE MESH, trocar point, 51 30, 70, 84, 105 NEEDLEHOLDER, 26-27, 42-43, 46-53 PROLENE* POLYPROPYLENE SUTURE, arming, 27, 59 18, 20, 25-26, 28, 30-31, 34-35, jaws, 51-52 37, 39, 61, 84, 103 NEUROSURGERY, 16, 34 PRONOVA* POLY NUROLON* BRAIDED NYLON (HEXAFLUOROPROPYLENE-VDF) SUTURE, 10, 13, 17, 20, 25, 34, 39, SUTURE, 18, 20, 25-26, 37, 39, 84 58-59, 83, 100 PROXI-STRIP* SKIN CLOSURES, 27, 40, 75, 84

O OPHTHALMIC SURGERY, 15, 35, 47, 66, 80, 83 R RESPIRATORY TRACT, 36 ORTHOPAEDIC SURGERY, 18, 49, 51 bronchial stump closure, 36 thoracic cavity, 36 RETENTION SUTURE DEVICES, 33, P PARENCHYMATOUS ORGANS, 29 77-78, 84 kidney, 3, 29, 51 liver, 29-30, 51 spleen, 29 S SECONDARY SUTURE LINE, 33 PDS* II (POLYDIOXANONE) SUTURE, continuous sutures, 19, 22, 24, 10, 15-16, 25, 31, 35, 38, 37 59-60, 83, 101 interrupted sutures, 19, 22, 24, PERMA-HAND* SILK SUTURE, 16, 25, 28, 30-31, 37 33, 59, 83, 102 railroad track scar, 33 PLASTIC SURGERY, 14, 17, 48, 51, 57, retention sutures, 33, 77-78, 84 83-84 SKIN, 2-5, 8, 10, 13-14, 16-17, 22, PRIMARY SUTURE LINE, 18, 22-23, 33 27-28, 31-34, 46-47 buried sutures, 22, 80 STITCH PLACEMENT, 23 continuous sutures, 19, 22, 37 STITCHES AND TYPES, 18-23 Connell Technique, 24 Connell Technique, 24 Cushing Technique, 24 Cushing Technique, 24 Lembert Technique, 24 Halsted Technique, 24 deep sutures, 19, 22, 69 horizontal mattress technique, interrupted sutures, 19, 22, 28, 19, 24 30-31, 38 Lembert Technique, 24 interrupted horizontal over-and-over technique, 19, 24 mattress suture, 19, 24 purse-string technique, 19, 22 interrupted vertical running technique, 19 mattress suture, 19, 24 CHAPTER 9 117

subcuticular technique, 19, 22 breaking strength, 2, vertical mattress technique, 20-21 19, 24 in vivo strength, SURGICAL GUT SUTURE, 14, 20, 58, 20-21 94, 110 burst strength, 2 chromic, 13-14, 20, 28, 32-33, 38, monofilament strands, 11, 80, 94, 97, 110 15, 17, 24, 31-32, 35 CHROMICIZING process, multifilament strands, 11, 14 16-17, 24, 29, 31-33 collagen pure, 12-14 size, 10-11, 13-16, 28 fast absorbing, 14, 27, 94 tensile strength, 2, 6, plain, 12-14, 20, 83, 94, 110 10-17, 23, 27, 31-33, TRU-GAUGING process, 13, 85 35, 38, 66, 85 tubing fluid, 85 tissue reaction, 12, 14-15, SURGICAL SILK SUTURE, 16, 28, 34 17-18, 26, 32-38 See also PERMA-HAND* silk suture labeling, 56-60 SURGICAL STAINLESS STEEL expiration date, 57, 60, 81 SUTURE, 16-17, 20, 25, 66, 111 Food and Drug SUTURE, 10-40 Administration (FDA), 12, absorbable suture, 15, 22, 27-32, 57, 60, 68, 81 38, 58-60, 80, 83, lot number, 57 85, 89 package insert, 57, 83 See also Coated VICRYL* product code, 57, 84 (polyglactin 910) suture; manufacture, 13, 16, 42, 57, 90 Coated VICRYL RAPIDE* nonabsorbable suture, 16, 18, (polyglactin 910) suture; 22-23, 26, 29, 31-32, 35, MONOCRYL* 57, 60, 63, 82-83 (poliglecaprone 25) See also ETHIBOND* EXCEL suture; PANACRYL* polyester suture; suture; PDS* II ETHILON* nylon suture; (polydioxanone) suture; MERSILENE* polyester surgical gut suture fiber suture; NUROLON* alloy suture, 16, 42, 48, 51, 81 braided nylon suture; wire gauge equivalents, PROLENE* polypropylene 17 suture; PRONOVA* See also surgical stain- poly(hexafluoropropy- less steel suture; lene-VDF) suture; surgical temporary cardiac silk suture pacing wire nylon suture, 10, 13, 17, 20, 25, characteristics, 10-11, 14, 16-17, 36, 40, 81, 83, 93, 99 24, 32 See also ETHILON* nylon absorption profile, 20-21 suture; NUROLON* hydrolysis, 15, 17, braided nylon suture 32, 35 packaging, 10, 16, 56-65 absorption rate, 14, 20-21 dispenser boxes, 56-57, braided strands, 18 60, 81, 83 environmentally conscious, 57

* Trademark 118 INDEX

primary packets, 56-57 SUTURE PREPARATION, 62 overwrap, 57, 59, 61-62, SUTURE REMOVAL, 11, 14, 26, 32-33, 64, 83 35, 68-69 peelable foil, 58 SUTURE TECHNIQUES, 28-34, 45 single strand and multi- double-layer closure, 28 strand packaging packets, inverted closure technique, 28 58, 82-83 single-layer closure, 28, 31 E-PACK* procedure Smaed-Jones far-and- kit, 54, 59, 61, 81 near technique, 31 EASY ACCESS* See also ligatures; primary suture packaging, 81 line; secondary suture line ETHI-PACK* pre-cut suture, 81 GENTLE BEND* T TAPES, 4, 32, 52, 56, 74-75 package, 82 skin closure tapes, 32, 74-75 LABYRINTH* umbilical tape, 75, 85 package, 82 See also MERSILENE* polyester looped suture, 19, fiber strip; PROXI-STRIP* skin 77, 82 closures RELAY* suture TENDON SURGERY, 39 delivery system, Bunnell Technique, 37, 39 56-58, 60-61, periosteum, 39, 51 64, 84 TISSUE ADHESIVES, 68-71 SUTUPAK* pre-cut See also DERMABOND* Topical sterile suture, 58, Skin Adhesive (2-Octyl 63, 85 Cyanoacrylate) storage racks, 56 TISSUE STRENGTH, 2 IV pole racks, 56 breaking strength, 2 modular storage burst strength, 2 racks, 56-57 tensile strength, 2, 6, 11-17, 23 polyester fiber suture, 13, 17, 20, 25, 58, 92, 95, 96 See also ETHIBOND* EXCEL U URINARY TRACT SURGERY, 38 polyester suture polypropylene suture, 18, 25-26, 28, 30, 32, 36-39, 66, 82-84, 102-103 See also PROLENE* polypropylene suture sterilization, 57, 60, 85, 90, 104 SUTURE CUTTING, 26 SUTURE HANDLING, 10-11, 26-27, 63 sterile barrer, 61 sterile field, 53, 56, 59-62, 64 sterile technique, 26, 75, 85 sterile transfer, 56, 60-62 sterile sterilization, 60 CHAPTER 9 119

V VASCULAR SURGERY, 11 heart valves, 21, 38, 99 VESSELS, 4, 6, 10, 14, 18, 24, 32, 37-38, 51, 59, 62, 75 pediatric, 15, 21, 75, 85 VICRYL* (POLYGLACTIN 910) KNITTED MESH, 30, 86, 112 VICRYL* (POLYGLACTIN 910) PERIODONTAL MESH, 35-36, 86 VICRYL* (POLYGLACTIN 910) SUTURE, 10, 14-15, 25, 34-35 VICRYL* (POLYGLACTIN 910) WOVEN MESH, 30, 86, 113

W WOUND CLASSIFICATION, 5-6 clean, 4-5 clean-contaminated, 5 contaminated, 6-7, 18 dirty and infected, 5-7, 18 WOUND COMPLICATIONS, 3 dehiscence, 16, 38, 68, 74, 81 dehydration, 3 edema, 2, 5-6, 11, 78 epithelialization, 7, 33, 35, 68 infection, 2-7, 10-12, 27, 31-32, 35, 35-36, 38-40 wound disruption, 23, 86 WOUND HEALING, 2-7, 10 collagen formation, 7 dehydration, 3 primary intention, 6 second intention, 6 delayed primary closure, 6

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© ETHICON, INC. 2004 *Trademark ETHICON, INC. • P.O. Box 151 • Somerville, NJ 08876-0151