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Use of Biodegradable Implant in and Surgery

Sheleib W*, Ebeid K, Lipin R and Smith O Research Article Department of Otolaryngology, Head and Surgery, Toronto East General Hospital, Canada Volume 6 Issue 1 Received Date: January 23, 2021 *Corresponding author: Walaa A Sheleib, Department of Otolaryngology, Head and Neck Published Date: February 08, 2021 Surgery, Toronto East General Hospital, University of Toronto, Toronto, Canada; Email: DOI: 10.23880/ooaj-16000206 [email protected]

Abstract

Its shape, size, position, and integrity help determine not only the patency of the nasal fossae but also the appearance of the nasalThe nasal pyramid. septum Achieving has a significant satisfactory influence functional on the and form aesthetic and function results ofpresents the nose, a real as it challenge is a key element for the surgeonof the nasal in a framework. wide range

system has been used to repair pediatric facial fractures. It provides stability during the initial period of healing until the bony fractureof nasal segments septal deformities. have reunited. During There the lastare many decade, differently the absorbable sized and biodegradable shaped plates plate with DePuySynthes varying thickness Rapidsorb available. fixation We

believe this is a useful technique to improve the rate of success, and with further experience, the indications and

role in septal surgery can be better defined. Keywords: Nasal septum; Septoplasty surgery; Septal reconstruction

Abbreviations: PPE: Perpendicular Plate of Ethmoid. cartilage reshaping procedures, (such as wedging, scoring, Septal straightening techniques can be classified as Introduction and morselizing), septal repositioning procedures and septal reconstruction techniques using either grafts or implants

form and function of the nose, as it is a key element of the nasalThe framework. nasal septum Its shape, has size, a significant position, and influence integrity on help the [6].such Septal as polydioxone cartilage grafts foil (PDS). are commonly Graft material considered used for the septal best determine not only the patency of the nasal fossae but also the reconstruction is preferably thin, strong, and of sufficient size appearance of the nasal pyramid [1]. Achieving satisfactory such as septal perforation, post trauma or revision surgery. functional and aesthetic results presents a real challenge graft material; however, this may be insufficient in some cases for the surgeon in a wide range of nasal septal deformities. septal cartilage increases morbidity, operative time and theWhen potential there isn’t for sufficient complications. septal cartilage,Some surgeons harvesting currently extra- The failure rate of septoplasty surgery remains unclear use of PDS foil for septal reconstruction. PDS foil serves as [2-5]. The more severe the deviation of the septum, the less a scaffold to support cartilaginous/bony grafts during early likely a postoperative midline septum, has been a commonly postoperative period [7]. noted observation. The position and shape of the septum often may appear satisfactory at the end of surgery, but During the last decade, the absorbable biodegradable

attributed in some cases to cartilaginous memory, which is has been used to repair pediatric facial fractures. Rapidsorb thoughtfailure within to promote the firstthe septum few weeks returning can stillto its occur. initial Thisshape. is plate DePuySynthes Rapidsorb fixation system (Rapidsorb)

is made from an 85:15 mixture of poly (L-lactide-co- Use of Biodegradable Implant in Rhinoplasty and Nasal Septum Surgery Otolaryngol Open Access J 2 Otolaryngology Open Access Journal glycolide). Its absorption characteristics are such that it Using Brown-Addson forceps, the septal cartilage and the retains 85% of its initial bending resistance at eight weeks. miniplate are pressed together to determine the degree of It then more rapidly breaks down such that less than 10% of improvement possible (Figures 2 A,B). its initial strength remains at twenty weeks. It is hydrolyzed into lactide and glycolide and is absorbed at the end of a year [6-8]. It provides stability during the initial period of healing until the bony fracture segments have reunited. There are many differently sized and shaped plates with varying thickness available.

Materials & Methods Patients: Biodegradable implant was used by the senior author on 124 patients from January 1, 2014, through August 31, 2017. The diagnosis, surgical procedure(s), complications, and outcomes were obtained. The evaluation of the surgical a midline, straight septum as documented by the senior outcome was based on examination and symptoms. Both required for a successful outcome. Figures 2A, B: Positioning of implant on the concave side surgeon and significant improvement in symptoms were of the septum. Technique

All the patients were given a single dose of antibiotic Often the best position occurs when the plate is perpendicular to a septal fracture line (Figure 3). use the implant on severely deviated septum was made only after(Cephalexin all other or Clindamycin)methods of creating preoperatively. a straight The and decision midline to septum had failed (Figure 1).

Figure 3: Right lateral view of the showing the nasal septum fracture line on the right side.

The surgically created disarticulation between the Figure 1: A case of severely deviated nasal septum Quadrangular cartilage and the bony vomer/perpendicular completely obstructing the left nasal cavity. plate of the ethmoid can at times be used to stabilize the posterior end of the plate. When this is possible, sometimes the plate can act as a wedge to push the cartilage towards the If the septum appeared to be both straight and midline, midline. If the cartilage has an intrinsic curvature and not a then the implant was not used. The plate used in all cases is

tearclearly occurs, identified the opposite fracture line,side findingcan be usedthe best although placement this is is34 placed mm x against6 mm x the1.5 septalmm and cartilage contains and eight positioned holes. It until is rigid the notmore necessary. difficult and If caudal generally septal takes trimming longer. Ifis a anticipated, septal mucosal the bestwith orientationlittle flexibility. is found. Using Brown-Addson forceps, the plate plate should be placed far enough posterior so as not to

The concave side of the septum is preferred. Should there can be trimmed using Mayo scissors, although this is seldom be residual curvature of the septum, the 1.5 mm thickness required.interfere with the planned excision later. However, the plate of the plate is less likely to impact the airway on this side.

Sheleib W, et al. Use of Biodegradable Implant in Rhinoplasty and Nasal Septum Surgery. Otolaryngol Copyright© Sheleib W, et al. Open Access J 2021, 6(1): 000206. 3 Otolaryngology Open Access Journal

When the best position has been determined, while the trauma. Previous surgery had been performed on forty- two plate is being held with the Brown-Addson forceps, it is sewn (34%) of the patients. The open approach to septoplasty was to the cartilage with 5-0 Polysorb sutures using the holes to used in 92 (74 %) patients. Twenty- one (17%) patients also stitch back and forth. The majority of the suture is usually used. Suturing starts by tying the plate to the septum at the approach was used in 11 (9%) (Table 1). caudal/anterior end of the septum and then proceeds to the underwent an extracorporeal septoplasty. The endonasal cephalic/posterior end. Then the suture is run back again to Patient No to the superior and inferior edges of the plate helps hold the Total No of Cases 124 platefinally tightly tie to tothe the loose cartilage end of (Figures the knot. 4 A,Stitching B). from a hole Primary Cases 82 Revision cases 42 Septal perforation 7 Open approach 92 21 Endonasal approach 11 Extracorporeal Septoplasty Table 1: Applications of Rapidsorb Implant in the 124 Study Patients.

The Implant was used in conjunction with perforated

with rib graft in seven (6%) patients and with auricular cartilageperpendicular in two plate (2%) of patients. ethmoid The bone implant in five was (4%) used patients, on the

2).left side in forty- six (37%) patients, the right side in seventy- Figures 4A, B: six (63%) patients and bilateral in two (2%) patients (Table septum using a 5-0-monosoft suture, B) Implant after A) Fixation of the implant to the nasal Patient No Total No of Cases 124 fixation to the septum showing a straight nasal septum. With no other graft 110 The tighter the plate to the septal cartilage, the greater With PPE 5 the improvement achieved. When the mucoperichondrial With rib cartilage 7 also create a tighter compression. The rigid plate can usually With auricular cartilage 2 beflaps felt are beneath subsequently the nasal sewn septal to the mucosa. septal cartilage,The suturing this can On right side 76 hold the open nasal speculum. The use of this plate adds on On left side 46 be difficult and often is made easier by having an assistant Bilaterally 2 Use of Rapidsorb Implant with other modalities. the average about fifteen minutes to surgery after sufficient Table 2: experience has been gained. The first several cases required At the three- month review, 111 (89%) patients reported an additional half an hour and in the author’s experience approximately twenty-five cases were necessary to become remained. Thirteen patients (10%) had swelling of the proficient with the technique. Results septuma significant on the reduction side of inimplant symptoms. placement One septal causing perforation ongoing symptoms of nasal blockage. The swelling had resolved Biodegradable Implant was used in septal or spontaneously in all patients at their 6 months post-operative septorhinoplasty surgery in 124 patients treated between January 1, 2014, and August 31, 2017. Follow-up ranged visit. Two patients (2%) developed partial plate exposure. partOne of patient the implant. reported The asymptomatic arising from patient the exposure. was observed This patients,from six with months a mean to two age yearsof 39.2 postoperatively. years (range 15-71 There years). were andpatient the underwentplate had disappeared a general anesthetic at the one-year to excise visit the (Table exposed 3). Twentyseventy- -four five (60.4%)(19%) patients male and had forty a known -nine history(39.6%) of female nasal

Sheleib W, et al. Use of Biodegradable Implant in Rhinoplasty and Nasal Septum Surgery. Otolaryngol Copyright© Sheleib W, et al. Open Access J 2021, 6(1): 000206. 4 Otolaryngology Open Access Journal

strut to maintain the septal cartilage in a straight plane. It is an Patient No additional method available to rescue a septum, which cannot Total No of Cases 124 be corrected by other means. The success of this technique Temporary Swelling on the side of the is based on the assumption that when the septal cartilage is 13 placement after surgery, then it will remain straight after the implant is Residual Perforation 1 nomaintained longer rigid. straight The databy the suggests implant this for is the the first case, few as initiallymonths 2 success did not fail with further follow up. PDS plates do not Table 3: Complications. Implant Extrusion authors to produce the same degree of improvement as the Comment have the necessary degree of rigidity in the experience of the was restricted to the most severe deviations requiring an use of biodegradable implant. The author’s initial experience was used with only the open approach and later still with the endonasalThe Implant approach is is easiest used. The to performauthors suggest using anusing extra- the extracorporeal technique. With greater experience the plate opencorporeal approach. technique. The biodegradable It is technically implant most difficult provides when a rigid an was adopted with progressively lesser degrees of deviation. endonasal approach. Again, with experience, this technique

A) Frontal View. B) Basal View. Figure 5: A 20-year-old patient with a severe nasal septum deviation to the left side, before and 12 months after combined

rhinoplasty and extracorporeal septoplasty using a biodegradablethe implant author’s placed opinion on the the left technique side of the created nasal septum.a greater degree of straightness than otherwise would have occurred. In most cases the implant created a straight septum, which otherwise would have been terminated with a residual deviation of the septum. The author’s current indication is any septoplasty where conventional methods fail to straighten the cartilage to the author’s satisfaction. The current implant shape and thickness were not designed for this application. The thickness is felt by the author to be greater than necessary, as the force needed to stabilize the septum is considerably less than required to bend the implant. The optimal length and width of the implant is currently unknown. We believe this is a useful technique to improve the rate of septoplasty Figure 6: A 35-year-old patient with crooked nose, (Frontal view) before and 8 months after septorhinoplasty using open approach and a biodegradable implant placed success, and with further experience, the indications and on left side of the nasal septum. role Acknowledgmentin septal surgery can be better defined (Figures 5 & 6). Although some cases using this technique still failed to All procedures performed were in accordance with the produce a straight, midline septum at the time of surgery, it is ethical standards of the 1964 Helsinki declaration and its

Sheleib W, et al. Use of Biodegradable Implant in Rhinoplasty and Nasal Septum Surgery. Otolaryngol Copyright© Sheleib W, et al. Open Access J 2021, 6(1): 000206. 5 Otolaryngology Open Access Journal later amendments. All participants gave informed consent. 5. Karatzanis AD, Fragiadakis G, Moshandrea J, Zenk J, Iro H, et al. (2009) Septoplasty outcome in patients with and References without allergic . Rhinology 47(4): 444-449. 1. Singh A, Patel N, Kenyon G, Donaldson G (2006) Is there 6. objective evidence that septal surgery improves nasal andRimmer Septal J, Surgery. Ferguson Arch LM, Facial Saleh Plast HA Surg (2012) 14(5): Versatile 323- 330.Applications of the Polydioxanone Platein Rhinoplasty 2. airflow? J Laryngol Otol 120(11): 916-920. nasal septal surgery. J Otolaryngol 21(2): 88-91. 7. Bergsma JE, Bruljin WC, Rozema FR, Bos RRM, Boering Samad I, Stevens HE, Maloney A (1992) The efficacy of 3. Illum P (1997) Septoplasty and compensatory inferior turbinate hypertrophy: long-term results after 25-31.G (1995) Late degradation tissue response to poly randomized turbinoplasty. Eur Arch Otorhinolaryngol (L-lactide) bone plates and screws. Biomaterials 16(1): 254(1): 89-92. 8. reaction to an intraosseous bioabsorbable polylactic 4. Dommerby H, Rasmussen OR, Rosborg J (1985) acidBostman screw. OM, A casePihlajamaki report. JHK Bone (1998) Joint Late Surg foreign-body Am 80(12): 1791-1794. Otorhinolaryngol Relat Spec 47(3): 151-157. Long-term results of septoplastic operations. ORL J

Sheleib W, et al. Use of Biodegradable Implant in Rhinoplasty and Nasal Septum Surgery. Otolaryngol Copyright© Sheleib W, et al. Open Access J 2021, 6(1): 000206.