Study About the Efficacy of an Aerosol Plastic Dressing in Wound

Total Page:16

File Type:pdf, Size:1020Kb

Study About the Efficacy of an Aerosol Plastic Dressing in Wound 1.0 ANCC CE Contact Hours Study About the Effi cacy of an Aerosol Plastic Dressing in Wound Prevention After Compressive Adhesive Dressing Application in Plastic Surgery Procedures Enrique Salmerón-González , MD Elena García-Vilariño , MD Pilar Vilariño-López , MD Cristina García-Pons , MD Cristina Escalante-Ibáñez , MD Alfonso A. Valverde-Navarro , MD The use of compressive adhesive bandages is widely men placed over a layer of an aerosol plastic dressing and extended in the fi eld of plastic, aesthetic, and reconstruc- another bandage placed directly over the skin. A statisti- tive surgery, and the apparition of skin damage after its cally signifi cant decrease in skin damage incidence was removal is a relatively frequent complication. The aim observed in areas in which the aerosol plastic dressing of this study was to evaluate the capacity of an aerosol was applied as a layer between the adhesive dressing and plastic dressing for protecting the skin from the apparition the skin. Furthermore, a reduction in symptoms associ- of damage caused by adhesive dressings. A prospective, ated with the use of these adhesive dressings was found. randomized, simple-blind study was performed, evaluating The results of this study support the use of aerosol plastic skin damage incidence after removal of adhesive compres- dressings as a barrier for skin protection in patients in sive bandages in 80 subjects. The patients carried for whom an adhesive compressive dressing is applied to 48 hr an adhesive compressive dressing on their abdo- reduce the incidence of skin damage. he use of adhesive compressive dressings is established seromas ( Rogliani, Gentile, & Cervelli, 2008 ). widely extended in the fi eld of aesthetic and re- The apparition of skin damage after removal of adhesive T constructive surgery, being frequently utilized for dressings is a common complication that causes blisters, coverage of the intervened area in abdominoplasties, erythema, skin irritation, itching, and pain ( Becerra Maya breast reduction and augmentation procedures, liposuc- et al., 2015 ; Esparza Imas et al., 2015 ). tions, and other procedures. Compressive bandages are The aim of this study was to evaluate the effect of utilized with the aim of reducing hematoma and hemor- an aerosol plastic dressing when utilized as a protec- rhage incidence after surgical procedures or vascular ma- tive barrier prior to the application of a compressive nipulations ( Epstein, Epstein, & Gutowski, 2015 ); to con- adhesive dressing, focusing on the incidence of skin trol postsurgical edema ( Lowell et al., 2003 ) and to treat damage, pain, and itching. Enrique Salmerón-González, MD, is a plastic surgeon, Department of Alfonso A. Valverde-Navarro, MD, is Head of the Department of Human Plastic Surgery and Burns, University and Polytechnic Hospital La Fe, Anatomy and Embriology, University of Valencia, Valencia, Spain. Valencia, Spain. None of the authors have a fi nancial interest in any of the products, de- Elena García-Vilariño, MD, is a plastic surgeon, Department of Plastic vices, or drugs mentioned in this article. The authors report no confl icts Surgery and Burns, University and Polytechnic Hospital La Fe, Valen- of interest . cia, Spain. Address correspondence to Enrique Salmerón-González, MD, Avenida de Pilar Vilariño-López, MD, is a general nurse, El Ventorrillo Medical Center, Fernando Abril Martorell, Number 106, 5th Floor, Block E, Secretary of A Coruña, Spain. Plastic Surgery, Valencia Post Code 46026, Comunidad Valenciana, Spain Cristina García-Pons, MD, is a plastic surgical nurse, Department of (e-mail: [email protected]). Plastic Surgery and Burns, University and Polytechnic Hospital La Fe, Copyright © 2018 International Society of Plastic and Aesthetic Nurses. Valencia, Spain. All rights reserved. Cristina Escalante-Ibáñez, MD, is a plastic surgical nurse, Servicio de Cirugía Plástica y Quemados, Hospital Universitario y Politécnico La Fe, Valencia, Spain. DOI: 10.1097/PSN.0000000000000229 Plastic Surgical Nursing www.psnjournalonline.com 101 Copyright © 2018 International Society of Plastic and Aesthetic Nurses. Unauthorized reproduction of this article is prohibited. MATERIALS AND METHODS Procedure After accepting their inclusion in the study, participants The study was conducted from July 2017 to August 2017 were assigned an ordinal number, corresponding with in two different health care centers: “El Ventorrillo” medi- the order in which they had been recruited. Following cal center, in A Coruña, Spain; and the University and this, the researchers in charge of the experimental part Polytechnic Hospital La Fe, in Valencia, Spain. It was de- of the study reviewed the computer application to check veloped in collaboration between general nurses from the order of the intervention and control zones in those the “El Ventorrillo” medical center and nurses and plas- subjects. If needed, the two abdominal zones in which tic surgeons from the Department of Plastic Surgery of the dressings would be applied were shaved with an the Hospital La Fe. The study consisted of a prospective, electric shaver. A layer of 1–2 mm of Plastospray was randomized, simple-blind study conducted on 80 healthy applied in the zone indicated by the randomization al- volunteers. The intervention consisted of the application gorithm, and after waiting for it to dry for 1 min, two of two adhesive compressive dressings (Tensoplast) on adhesive compressive dressings (Tensoplast) measuring the abdominal region of every subject, with one ban- 15 cm in length were applied vertically over each side dage placed vertically on either side of the abdomen. The of the abdomen. The distal part was fi xed fi rst, sticking aerosol plastic dressing was applied only on one side of the rest of the bandage progressively, while more ten- the abdomen before placing the dressing. The side on sion was applied, compressing the skin (Figure 1A) . The which the aerosol plastic dressing was applied had been participant was evaluated 48 hr later. During evaluation, previously randomized through a computer program that the dressings were removed and the existence of skin assigned the right side as the intervention zone for 40 damage and symptoms caused by bandage wearing were participants and the left side for the other 40 volunteers, assessed ( Figure 1B ). according to an algorithm that remained unknown for the researchers in charge of the evaluation of the results. Every volunteer was evaluated 48 hr after dressing ap- RESULTS plication. Inclusion criteria included people older than 18 years and able to voluntarily participate in the proj- Eighty volunteers participated in this study, of which ect. People who suffered from systemic skin conditions 44 were females and 36 males. The average age or who were undergoing corticoid treatment were also was 54 years 3 months, with a standard deviation included in the study despite skin frailty that is caused of 8 years 2 months. All the participants attended by these conditions. The reason for their inclusion was the revision 2 days after the intervention. Forty-fi ve that every subject had an intervention zone and a control percent of the patients were shaved before the appli- zone, thus eliminating the possibilities of bias related to cation of the aerosol plastic dressing and the adhe- interpersonal variations. After dressing removal, the ex- sive bandage. Relevant comorbidities related to skin istence of skin damage and the apparition of symptoms conditions and healing conditioning factors are sum- such as itching or pain were assessed. Pain was evalu- marized in Table 1 . ated through a visual analogue scale, and it was consid- The results observed after removing the compressive ered signifi cant when the value was equal or higher than adhesive dressing are summarized in Table 2 . The only 4. The statistical analysis tool utilized for evaluation of allergic reaction reported was related to the adhesive sub- our results was the 2 test. Institutional review board ap- stance present in the adhesive dressing and not with the proval was provided from our institution. Informed con- aerosol plastic dressing, which was verifi ed after evalu- sent was obtained from all patients included in this study. ation of that participant by an allergologist. Symptom FIGURE 1. (A) Dressing placement. (B) Aspect 48 hr after removal of the dressing: Cutaneous erythema in the control zone can be observed. 102 www.psnjournalonline.com Volume 38 Number 3 July–September 2018 Copyright © 2018 International Society of Plastic and Aesthetic Nurses. Unauthorized reproduction of this article is prohibited. TABLE 1 Subjects’ Comorbidities TABLE 3 Symptoms Reported After Wearing the Comorbidities n Adhesive Dressing for 48 hr Diabetes mellitus 18 Control zone Intervention zone p Smoking 22 No symptoms 57 (71.25%) 68 (85%) .0354 Corticoid intake 8 Pruritus 16 (20%) 9 (11.25%) .1274 Psoriasis 3 Pain 7 (8.75%) 3 (3.75%) .1892 Allergic dermatitis 6 Seborrheic dermatitis 1 rier after oncological-gynecological interventions. Becerra Atopic dermatitis 4 Maya et al. (2015) also published a case–control study in which a reduction in pain was reported in the group that Chemotherapy 2 utilized an aerosol plastic dressing for coverage of episi- otomies or vaginal wounds after birth. incidence related to the intervention and control zones is summarized in Table 3. LIMITATIONS Despite that the design of this study guarantees that every DISCUSSION subject has an intervention and a control zone, a better The results of
Recommended publications
  • Skin As a Mirror of Gastrointestinal Diseases
    Review article Skin as a mirror of gastrointestinal diseases Sunil Kumar Gupta1, Amanjot Kaur Arora1, Jasveen Kaur1, Veenu Gupta2, Deepinder Kaur2 Department of Dermatology, Venerology and Leprology1, Department of Microbiology2, Dayanand Medical College and Hospital, Ludhiana, Punjab, India ABSTRACT The closely related origins of the skin and the gastrointestinal system make for a fascinating grouping of diseases with concomitant involvement of these two important organ systems. The dermatologic manifestations may precede clinically evident gastrointestinal disease and help in early diagnosis, saving unnecessary wastage of time and resources. In this overview, we review the cutaneous manifestations of various hereditary, neoplastic and inflammatory gastrointestinal diseases including the various polyposis syndromes, hereditary colorectal cancers, inflammatory bowel diseases, etc. Dermatologic manifestations of acute and chronic hepatic and pancreatic diseases have also been discussed. This review underscores the importance of collaboration between dermatologists and gastroenterologists for better and efficient management of the affected patients. Keywords: Gastrointestinal diseases, Genodermatoses, Hepatitis, Inflammatory bowel disease, Pancreatic diseases, Polyposis syndromes INTRODUCTION diseases with skin and GIT involvement, genodermatoses, and the various hereditary Skin is the largest organ of the body. With a wide surface gastrointestinal cancers. area and being the outermost covering of the human body, skin has proven to be of good diagnostic help or atleast II.Cutaneous manifestations of liver diseases raise the index of suspicion that something inside the covering is wrong. Like many other systemic diseases, III.Cutaneous manifestations of pancreatic diseases. ,gastrointestinal tract (GIT) diseases may present with I. CUTANEOUS MANIFESTATIONS OF cutaneous symptoms, either primarily or secondarily as a GASTROINTESTINAL DISEASES sequalae to gut pathology, embryologic development being responsible for such clinically important associations.
    [Show full text]
  • Wound Classification
    Wound Classification Presented by Dr. Karen Zulkowski, D.N.S., RN Montana State University Welcome! Thank you for joining this webinar about how to assess and measure a wound. 2 A Little About Myself… • Associate professor at Montana State University • Executive editor of the Journal of the World Council of Enterstomal Therapists (JWCET) and WCET International Ostomy Guidelines (2014) • Editorial board member of Ostomy Wound Management and Advances in Skin and Wound Care • Legal consultant • Former NPUAP board member 3 Today We Will Talk About • How to assess a wound • How to measure a wound Please make a note of your questions. Your Quality Improvement (QI) Specialists will follow up with you after this webinar to address them. 4 Assessing and Measuring Wounds • You completed a skin assessment and found a wound. • Now you need to determine what type of wound you found. • If it is a pressure ulcer, you need to determine the stage. 5 Assessing and Measuring Wounds This is important because— • Each type of wound has a different etiology. • Treatment may be very different. However— • Not all wounds are clear cut. • The cause may be multifactoral. 6 Types of Wounds • Vascular (arterial, venous, and mixed) • Neuropathic (diabetic) • Moisture-associated dermatitis • Skin tear • Pressure ulcer 7 Mixed Etiologies Many wounds have mixed etiologies. • There may be both venous and arterial insufficiency. • There may be diabetes and pressure characteristics. 8 Moisture-Associated Skin Damage • Also called perineal dermatitis, diaper rash, incontinence-associated dermatitis (often confused with pressure ulcers) • An inflammation of the skin in the perineal area, on and between the buttocks, into the skin folds, and down the inner thighs • Scaling of the skin with papule and vesicle formation: – These may open, with “weeping” of the skin, which exacerbates skin damage.
    [Show full text]
  • Pressure Ulcer Staging Cards and Skin Inspection Opportunities.Indd
    Pressure Ulcer Staging Pressure Ulcer Staging Suspected Deep Tissue Injury (sDTI): Purple or maroon localized area of discolored Suspected Deep Tissue Injury (sDTI): Purple or maroon localized area of discolored intact skin or blood-fi lled blister due to damage of underlying soft tissue from pressure intact skin or blood-fi lled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, fi rm, mushy, boggy, and/or shear. The area may be preceded by tissue that is painful, fi rm, mushy, boggy, warmer or cooler as compared to adjacent tissue. warmer or cooler as compared to adjacent tissue. Stage 1: Intact skin with non- Stage 1: Intact skin with non- blanchable redness of a localized blanchable redness of a localized area usually over a bony prominence. area usually over a bony prominence. Darkly pigmented skin may not have Darkly pigmented skin may not have visible blanching; its color may differ visible blanching; its color may differ from surrounding area. from surrounding area. Stage 2: Partial thickness loss of Stage 2: Partial thickness loss of dermis presenting as a shallow open dermis presenting as a shallow open ulcer with a red pink wound bed, ulcer with a red pink wound bed, without slough. May also present as without slough. May also present as an intact or open/ruptured serum- an intact or open/ruptured serum- fi lled blister. fi lled blister. Stage 3: Full thickness tissue loss. Stage 3: Full thickness tissue loss. Subcutaneous fat may be visible but Subcutaneous fat may be visible but bone, tendon or muscle are not exposed.
    [Show full text]
  • Angina Bullosa Haemorrhagica (Oral Blood Blister) (PDF)
    Patient Information Maxillo-facial Angina Bullosa Haemorrhagica (Oral Blood Blister) What is Angina Bullosa Haemorrhagica? Angina Bullosa Hemorrhagica (ABH) is a condition where an often painful, but benign blood-filled blister suddenly develops in the mouth. The blisters are generally not due to a blood clotting disorder or any other medical disorder. It is a fairly common, sudden onset and benign blood blistering oral (mouth) disorder. It mainly affects people over 45 years and both males and females are equally affected. Usually there is no family history of the condition. It may be associated with Type 2 Diabetes, a family history of diabetes or Hyperglycaemia. What are the signs and symptoms of ABH? The first indication is a stinging pain or burning sensation just before the appearance of a blood blister The blisters last only a few minutes and then spontaneously rupture (burst), leaving a shallow ulcer that heals without scarring, discomfort or pain They can reach an average size of one to three centimetres in diameter The Soft Palate (back of the mouth) is the most affected site If they occur on the palate and are relatively big, they may need to be de-roofed (cut and drained) to ease the sensation of choking Patient Information Occasionally blisters can occur in the buccal mucosa (cheek) and tongue Approximately one third of the patients have blood blisters in more than one location. What are the causes of ABH? More than 50% of cases are related to minor trauma caused by: hot foods, restorative dentistry (fillings, crowns etc) or Periodontal Therapy (treatment of gum disease).
    [Show full text]
  • CLINICAL RESEARCH PROJECT Protocol #11-H-0134 Drug Name: Eltrombopag (Promacta®) IND Number: 104,877 IND Holder: NHLBI OCD Date: January 2, 2019
    CLINICAL RESEARCH PROJECT Protocol #11-H-0134 Drug Name: eltrombopag (Promacta®) IND number: 104,877 IND holder: NHLBI OCD Date: January 2, 2019 Title: A Pilot Study of a Thrombopoietin-receptor Agonist (TPO-R agonist), Eltrombopag, in Moderate Aplastic Anemia Patients Other Identifying Words: Hematopoiesis, autoimmunity, thrombocytopenia, neutropenia, anemia, stem cells, cytokine, Promacta® (eltrombopag) Protocol Principal Investigator: *Cynthia E. Dunbar, M.D., TSCBB, NHLBI (E) Medically and Scientifically Responsible Investigator: *Cynthia E. Dunbar, M.D., TSCBB, NHLBI (E) Associate Investigators: *Georg Aue, M.D., OCD, NHLBI (E) *Neal S. Young, M.D., Chief, HB, NHLBI (E) *André Larochelle, M.D., Ph.D., CMTB, NHLBI (E) David Young, M.D., TSCBB, NHLBI (E) Susan Soto, M.S.N., R.N., Research Nurse, OCD, NHLBI(E) Olga Rios, RN, Research Nurse, OCD, NHLBI (E) Evette Barranta, R.N, Research Nurse, OCD, NHLBI (E) Jennifer Jo Kyte, DNP, Research Nurse, OCD, NHLBI (E) Colin Wu, PhD, Biostatistician, OBR, NHLBI (E) Xin Tian, PhD, Biostatistician, OBR/NHLBI (E) *Janet Valdez, MS, PAC, OCD, NHLBI (E) *Jennifer Lotter, MSHS, PA-C., OCD, NHLBI (E) Qian Sun, Ph.D., DLM, CC (F) Xing Fan, M.D., HB, NHLBI (F) Non-NIH, Non-Enrolling Engaged Investigators: Thomas Winkler, M.D., NHLBI, HB (V)# # Covered under the NIH FWA Independent Medical Monitor: John Tisdale, MD, NHLBI, OSD 402-6497 Bldg. 10, 9N116 * asterisk denotes who can obtain informed consent on this protocol Subjects of Study: Number Sex Age-range 38 Either ≥ 2 years and weight >12 kg Project Involves Ionizing Radiation? No (only when medically indicated) Off-Site Project? No Multi center trial? No DSMB Involvement? Yes 11-H-0134 1 Cynthia E.
    [Show full text]
  • Hand Blisters in Major League Baseball Pitchers: Current Concepts and Management
    A Review Paper Hand Blisters in Major League Baseball Pitchers: Current Concepts and Management Andrew R. McNamara, MD, Scott Ensell, MS, ATC, and Timothy D. Farley, MD Abstract Friction blisters are a common sequela of spent time on the DL due to blisters. More- many athletic activities. Their significance can over, there have been several documented range from minor annoyance to major per- and publicized instances of professional formance disruptions. The latter is particularly baseball pitchers suffering blisters that did true in baseball pitchers, who sustain repeat- not require placement on the DL but did ed trauma between the baseball seams and result in injury time and missed starts. the fingers of the pitching hand, predominate- The purpose of this article is to review ly at the tips of the index and long fingers. the etiology and pathophysiology of friction Since 2010, 6 Major League Baseball blisters with particular reference to baseball (MLB) players accounted for 7 stints on the pitchers; provide an overview of past and disabled list (DL) due to blisters. These inju- current prevention methods; and discuss ries resulted in a total of 151 days spent on our experience in treating friction blisters the DL. Since 2012, 8 minor league players in MLB pitchers. riction blisters result from repetitive friction of rubbing (erythroderma). This is followed by a and strain forces that develop between the pale, narrow demarcation, which forms around the F skin and various objects. Blisters form in reddened region. Subsequently, this pale area fills areas where the stratum corneum and stratum in toward the center to occupy the entire affected granulosum are sufficiently robust (Figure), such area, which becomes the blister lesion.1,2 as the palmar and plantar surfaces of the hand and Hydrostatic pressure then causes blister fluid feet.
    [Show full text]
  • MADSTONES with an ACCOUNT of SEVERAL from VIRGINIA* by WYNDHAM B
    MADSTONES WITH AN ACCOUNT OF SEVERAL FROM VIRGINIA* By WYNDHAM B. BLANTON, M.D. RICHMOND, VA. MBEDDED in the folklore more, though it often adhered of of many nations is a belief its own accord. It was then removed in the efficacy of all sorts of and placed in warm milk. If bubbles medicinal stones and among and a greenish color appeared in the them the madstone is of particularmilk the stone was supposed to be interest.E Madstones have been vari- giving up the poison it had extracted. ously known as snakestones, Chinese The stone was then reapplied to the snakestones, Indian snakestones, ser- surface and theoretically the process pent stones, adder stones, sucking was kept up until no further bubbles stones and bezoar stones. Typical and no more discolorations of the specimens are usually small, light, milk were to be observed. porous, stonelike objects, often with The theory upon which these porous one surface flattened. They possess stones were used was clearly one definite absorptive qualities and are of physical absorption. Some have believed to be capable of extracting been shown to increase their weight the poison from a poisonous bite, as much as 5 per cent when applied especially the poison of a mad dog. Ob- to a wet surface, but in a number of jects from many sources and of many instances well-controlled experiments different compositions have been con- with animals injected with snake sidered to possess the miraculous venom have clearly demonstrated the powers ascribed to madstones, but utter worthlessness of the madstone. in general real madstones are com- The explanation of the popularity posed of (i) a light porous substance of the madstone is due to the fact made by a secret process such as was that contrary to common belief most known to certain natives of India; dog bites are inflicted by animals (2) some porous form of calcareous who are not mad and are therefore rock, such as halloysite, a mineral of themselves harmless.
    [Show full text]
  • A Handbook of Clinical Signs in Black and Brown Skin
    ■ - A HANDBOOK OF CLINICAL SIGNS IN BLACK AND BROWN SKIN - MUKWENDE M, TAMONV P, TURNER M FIRST EDITION �---0 � � - ·� · St Georges University of London www.blackandbrownskin.co.uk INTRODUCTION There is more and more literature on the need for medical schools to address the equality and diversity agenda in order to ensure that future doctors can effectively treat the diverse population in the UK. The COVID-19 pandemic has highlighted how marginalised and particularly BME communities have poorer health outcomes. If medicine does not decolonize its curriculum and teach students to recognise signs and symptoms on darker skin tones there will be delays in diagnosis or misdiagnosis (Gishen & Lokugamage 2019). As well as offering images of conditions on black and brown skins frequently omitted in text books we have also looked at language and descriptors that often assume the patient is white. GMC- EQUALITY, DIVERSITY "The principles of equality, diversity and fair treatment are embedded in our core ethical standards and requirements that doctors must meet in medical education and training. Implementing this strategy is a contribution to improving standards of care for all patients by raising awareness of our expectations and making sure: · Doctors are equipped to treat the diversity of patients and services users in the UK population, irrespective of where they train · Doctors are able to use their diverse backgrounds and experiences to deliver innovative care that can respond to the diverse needs of their patients ... " 2 www.blackandbrownskin.co.uk AUTHORS & ACKNOWLEDGEMENTS CO-AUTHORS Malone Mukwende, Medical Student Dr Peter Tamony, Clinical Lecturer Margot Turner, Senior Lecturer CONTRIBUTORS & ACKNOWLEDGMENTS Many thanks to all those who helped with the Student-Staff partnership and the development of this handbook.
    [Show full text]
  • Eponyms Linked to „Signs'' in the Dermatology
    Historical Article DOI: 10.7241/ourd.20134.146 EPONYMS LINKED TO „SIGNS’’ IN THE DERMATOLOGY LITERATURE Khalid Al Aboud1, Ahmad Al Aboud2 1Department of Public Health, King Faisal Hospital, Makkah, Saudi Arabiaa Source of Support: 2Dermatology Department, King Abdullah Medical City, Makkah, Saudi Arabia Nil Competing Interests: None Corresponding author: Dr. Khalid Al Aboud [email protected] Our Dermatol Online. 2013; 4(4): 579-581 Date of submission: 14.06.2013 / acceptance: 16.07.2013 Cite this article: Khalid Al Aboud, Ahmad Al Aboud: Eponyms linked to „signs’’ in the dermatology literature. Our Dermatol Online. 2013; 4(4): 579-581. The word “sign” refers to important physical finding or Editor – in-Chief of this journal along with other authors had observation made by the physician when examining the patient. published alphabetical series entitled ‚’DERMATOLOGY Dermatologic diagnosis relies on the careful observation and EPONYMS – SIGN – LEXICON’’, where they elaborated on documentation of signs, which can be highly pathognomonic the signs seen in dermatology. for a certain conditions. Most of the signs appear either de novo In this communication, we aimed to highlight on selected or have to be elicited by the physician [1]. eponyms linked to ‚’signs’’ in the dermatology literature, shown There are important publications which gathered the signs seen in Table I [1-11]. in dermatology practice. In addition, Dr Piotr Brzeziński, the Eponyms linked to „signs’’ in the Remarks dermatology literature Albright’s dimple sign [1-5] This is seen in Albright’s hereditary osteodystrophy in which there is presence of a dimple over the knuckle of the typically affected fourth metacarpal and can be enhanced by clenching of the fist.It is named for Fuller Albright (1900-1969), (Fig.
    [Show full text]
  • Rituximab Therapy in Pemphigus and Other Autoantibody-Mediated Diseases [Version 1; Peer Review: 3 Approved] Nina A
    F1000Research 2017, 6(F1000 Faculty Rev):83 Last updated: 17 JUL 2019 REVIEW Rituximab therapy in pemphigus and other autoantibody-mediated diseases [version 1; peer review: 3 approved] Nina A. Ran, Aimee S. Payne Department of Dermatology, University of Pennsylvania, 1009 Biomedical Research Building, 421 Curie Boulevard, PA, USA First published: 27 Jan 2017, 6(F1000 Faculty Rev):83 ( Open Peer Review v1 https://doi.org/10.12688/f1000research.9476.1) Latest published: 27 Jan 2017, 6(F1000 Faculty Rev):83 ( https://doi.org/10.12688/f1000research.9476.1) Reviewer Status Abstract Invited Reviewers Rituximab, a monoclonal antibody targeting the B cell marker CD20, was 1 2 3 initially approved in 1997 by the United States Food and Drug Administration (FDA) for the treatment of non-Hodgkin lymphoma. Since version 1 that time, rituximab has been FDA-approved for rheumatoid arthritis and published vasculitides such as granulomatosis with polyangiitis and microscopic 27 Jan 2017 polyangiitis. Additionally, rituximab has been used off-label in the treatment of numerous other autoimmune diseases, with notable success in pemphigus, an autoantibody-mediated skin blistering disease. The efficacy F1000 Faculty Reviews are written by members of of rituximab therapy in pemphigus has spurred interest in its potential to the prestigious F1000 Faculty. They are treat other autoantibody-mediated diseases. This review summarizes the commissioned and are peer reviewed before efficacy of rituximab in pemphigus and examines its off-label use in other publication to ensure that the final, published version select autoantibody-mediated diseases. is comprehensive and accessible. The reviewers Keywords who approved the final version are listed with their Pemphigus , desmoglein , rituximab , autoantibody-mediated diseases , names and affiliations.
    [Show full text]
  • RECELL Autologous Cell Harvesting Device (RECELL Device) Should Be Used Only by Licensed Healthcare Professionals Trained in the Use of the Device
    June 9, 2021 U.S. Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993‐0002 RE: Amendment to BP170122/287 – PMA Panel-Track Supplement - RECELL® Label Expansion Revised IFU Dear Document Control Center: AVITA Medical is submitting the IFU documentation required to address the Agency’s revision request received via email from Nevitt Morris on June 9, 2021. The existence of this submission and the data and other information that it contains are confidential and not subject to disclosure as provided in 21 CFR 814.9. Please contact Sandra Aprahamian at 661‐749‐9422, by email at [email protected] if there are any questions regarding this submission. Sincerely, Sandra Aprahamian Director, Regulatory Affairs AVITA Medical 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 P +1(661) 367-9170 | f +1 (661) 367-9180 | avitamedical.com INSTRUCTIONS FOR USE RECELL® Autologous Cell Harvesting Device The RECELL Autologous Cell Harvesting Device (RECELL Device) should be used only by licensed healthcare professionals trained in the use of the device. Warning: The RECELL Autologous Cell Harvesting Device is internally powered by four non‐replaceable AA batteries (1.5V). The device should not be used in the presence of flammable anesthetic mixtures. Do not incinerate batteries on disposal. The performance of the device may be affected by sources of electromagnetic radiation and if any malfunctions are noted, all possible sources of electromagnetic radiation must be removed before further use. Caution: Federal law restricts this device to sale by or on the order of a physician.
    [Show full text]
  • Minor Burn Injuries
    Hand and Plastic surgery Injury clinic Minor Burn Injuries Information for patients Your burn has been assessed in the Emergency Department and you have been referred to the Hand and Plastic surgery Injury clinic (HAPI) for review in around two days. This leaflet should help you understand more about your burn injury and how to look after it, both before and after you come to your appointment. Dressing changes Your burn may have been covered with a dressing, which will need to be kept clean and dry. You will usually have a dressing change and review of your wound two times a week in the plastic dressing clinic, followed by a final assessment of the burn injury in the HAPI clinic around two weeks after your burn. If your burn heals quickly you may be discharged sooner. The dressing should be changed in the HAPI clinic if it accidentally becomes wet, begins to fall off or if fluid seeps through from your burn. If this happens, please contact the HAPI clinic for advice. You will need to wear the dressing until your wound has healed well enough for you to leave it uncovered. Your burn has been dressed with: ........................................................................................................................................................................................................ ........................................................................................................................................................................................................ .......................................................................................................................................................................................................
    [Show full text]