Premarket Approval Application No. Abbasian B, Kazemini H, Esmaeili A, Adibi S. Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats. 2013;29(3):459-470, Morris A, Samsell B, Dorsch K, et al. Partial and full-thickness neuropathic diabetic foot ulcers that are greater than 6 weeks in duration with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care; Oro-nasal fistula following cleft palate repair. 2010;81(2):237-244. Stability of double-row rotator cuff repair is not adversely affected by scaffold interposition between tendon and bone. UpToDate Inc., Waltham, MA. Healthcare Common Procedure Coding System (HCPCS). Furthermore, the tendency toward treating patients with bioactive splitthickness skin allograft (BSA) after failure with SOC may also have diminished the quality of the subject match. Plast Reconstr Surg. Dire consequences of the indiscriminate use of Teflon felt pledgets. ReCell is a medical device that processes skin samples in the operating room into a cell suspension to be sprayed on or dripped onto a wound. There was strong evidence of tissue incorporation and blood vessel infiltration. The placental extracellular matrix (ECM) supports healing by modulating correct tissue reconstruction rather than scar tissue formation. The use of Hyalomatrix PA in the treatment of deep partial-thickness burns. Int Wound J. Custom sizes and thicknesses are available upon request. Wound treatment with human skin equivalent. Dasgupta A, Orgill D, Galiano RD, et al. They are available in 0.5 cc, 1 cc and 2 cc dose sizes. K050355. BMC Bioinformatics. PROVANT Wound-Closure System accelerates closure of pressure wounds in a randomized, double-blind, placebo-controlled trial. Edison, NJ: MTF; 2015. Skin grafting for venous leg ulcers. Liden BA, May BC. UpToDate [online serial]. Park MJ, Lee AT, Yao J. Growth factors and wound healing in otolaryngology. Dunschede F, et al. 2009;16(1):26-37. Snyder DL, Sullivan N, Margolis D, et al. Landsman AS, Cook J, Cook E, et al. Int Urogynecol J. #: OF1-000119-en-US Version: K 2005;26(4):344-347. Musculoskeletal Transplant Foundation (MTF). Accessed March 4, 2005. 2017;43(4):804-811. TEI Biosciences Inc. Boston, MA. Case Rep Otolaryngol. Ann Plast Surg. Zastrow RK, London DA, Parsons BO, Cagle PJ. and 5/box). A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Aycock J, Fichera A, Colwell JC, Song DH. Surg Endosc. Technology Assessment Program: Skin substitutes for treating chronic wounds. Hayes et al (2020) stated that venous leg ulcers (VLUs) have a significant impact on approximately 3 % of the adult population worldwide, with a mean NHS wound care cost of 7,600 per VLU over 12 months. K081635. Am J Sports Med. Other references provided by the manufacturer of TheraSkin are to studies that are either unpublished or arein journals not indexed by the National Library of Medicine MEDLINE database of peer-reviewed journals (Soluble Systems, 2011; Lin, et al., 2011; Budny and Ley, 2013; Treadwell, 2011; DiDomenico, et al., 2011). J Med Case Rep. 2014;8:251. Reda F, Kjartansson H, Jeffery SLA. This was a small prospective cohort study with only 23 patients and no control arm. 2013;471(8):2455-2458. 2014;11(5):554-560. WoundEx Flow is supplied in single use: 0.5cc, 1.0 cc, 1.5 cc, 2.0 vials. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. NICE clinical guideline. SkinTE (PolarityTE, Inc., Salt Lake City, UT) is a fully autologous, homologous product for the repair, reconstruction, replacement, supplementation and regeneration of defects or functional losses of the skin of human patients. 2011;32(5):S545-S549. 2016;1:59-62. Used as an anatomical barrier or wrap in a variety of orthopedic applications. 2018;15(5):731-739. 2016;16:e10. Pennington WT, Chen SW, Bartz BA, Pauli JM. The investigators monitored time to reepithelialization, wound pain, discomfort during dressing changes, and treatment cost. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: The RICH Study. 2013;(7):CD009101. Wound-related costs and product waste were lower for CHSA compared with BLCC. 2009;25(11):1233-1239. Vin F, Teot L, Meaume S. The healing properties of Promogran in venous leg ulcers. Lanier ST, Wang ED, Chen JJ, et al. Couture M. Does continuous diffusion of oxygen have potential in chronic diabetic foot ulcers? Effectiveness measures were evaluated and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes up to 1 year following treatment. Augmentation of Achilles tendon repair with extracellular matrix xenograft:A biomechanical analysis. Dermatology. Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G. Bioengineered skin substitutes for the management of burns:A systematic review. A previously discounted flap now reconsidered: MatriDerm and split-thickness skin grafting for tendon cover following dorsalis pedis fasciocutaneous flap in lower limb trauma. Diagnoses or procedures may be subject to coding error, for which the extent of miscoding or under-coding that could result in bias is unknown, and may also result in measurement error in ICD-9/10 or CPT based variables. The Signature APatch is a cryopreserved, minimally engineered amniotic membrane allograft for homologous precision cut matrix for direct application as a would cover or physical barrier to acute or chronic wounds, including but not limited to venous leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds, burns, and wounds with exposed tendon, muscle, and/or bone. 2014;3(4):e487-e489, Hirahara AM, Adams CR. World J Emerg Surg. Faga A, Nicoletti G, Brenta F,et al. A non-contact video analysis permitted normalization of stretch within the repair region. Robinson PM, Muir LT. Foreign body reaction associated with Artelon: Report of three cases. 2015;19(1):135-140. Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction:A prospective comparative study. Am J Surg. Obes Surg. Br J Dermatol. The authors concluded that the ReCell system was a feasible, simple and safe technique. Logistic regression analysis of healing rates according to wound size, wound location, wound duration, volume reduction, exposed deep structures, and Wagner grade was carried out. J Am Coll Surg. Superior capsule Rreconstruction: What do we know? J Plast Reconstr Aesthet Surg. Thamboo A, Thamboo A, Philpott C,et al. Cambridge, MA: Genzyme; 2010. J Wound Care. J Plast Reconstr Aesthet Surg. TenSIX acts as a scaffold to facilitate angiogenesis and migration of growth factors that stimulate cell migration. Motolese A, Vignati F, Brambilla R, et al. 2015;4(6):e833-e839. Human acellular dermal wound matrix: Evidence and experience. Ganio C, Tenewitz FE, Wilson RC, Moyles BG. Agency for Healthcare Research and Quality's (AHRQ). The epithelial layer of the Arthrex Amnion Matrix is facing upward when the triangle notch is on the upper left-hand corner of the graft. Still J, Glat P, Silverstein P, et al. 2008;181(3):2103-10. Blome-Eberwein et al (2021) conducted a retrospective chart review encompassing a 4-year study period toassess complications and outcomes using absorbable synthetic membrane (Suprathel) to treat second degree burns. Guo Y, Chen G, Tian G, Tapia C. Sensory recovery following decellularized nerve allograft transplantation for digital nerve repair. The fluid tissue combination contains collagens, growth factors, and other key biologic components. Giordano P, Sileri P, Buntzen S, et al. Duerr RA, Ackermann J, Gomoll AH. Helton WS, Fisichella PM, Berger R,et al. Platelet-rich plasma and platelet gel: A review. Hand (N Y). Giza E, Frizzell L, Farac R,et al. Caravaggi C, De Giglio R, Pritelli C, et al. BJU Int. This composition of multiple ECM sources is in stark contrast to all current products derived from a single ECM source. Acellular Matrix: A Matrix that is derived from sources other than human skin. Chan S, McCullough J, Schizas A,et al. 2013;10(2):132-137. It is "indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to: defect of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological surgical reinforcement including but not limited to, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical application, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons." Bell R, Desai S, House H,et al. J Shoulder Elbow Surg. In a prospective, within-subject controlled, randomized, multi-center trial, these researchers examined ReCell in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (ReCell treatment) for the treatment of mixed-depth burns, including full-thickness (n = 30 subjects). Eur J Obstet Gynecol Reprod Biol. Giuffrida AY, Gyuricza C, Perino G, Weiland AJ. A randomized controlled study. 2015;115(6):968-977. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. 2008;(4):CD002106. Fitchburg, WI: Imbed Biosciences; 2022. J Shoulder Elbow Surg. Int Wound J. Biobrane versus 1% silver sulfadiazine in second-degree pediatric burns. J Burn Care Rehabil. Coulomb B, Friteau L, Baruch J, et al. This process provides a type of epidermal autograft that is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older. The average TBSA (Total Body Surface Area) was 8.9% (1%-60%). Silver dressings for the treatment of patients with infected wounds:A review of clinical and cost-effectiveness. U.S. Food and Drug Adminstration (FDA). Vashi C. Clinical outcomes for breast cancer patients undergoing mastectomy and reconstruction with use of DermACELL, a sterile, room temperature acellular dermal matrix. 2012;25(6):253-260. In a retrospective, propensity matched-cohort study, Gurtner and colleagues (2020) examined data from 2,074,000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1,997) versus SOC alone (n = 1,997). 2006;88(12):2673-2686. Schwarze et al (2008) conducted a prospective, randomized, nonblinded, clinical study toevaluate the impact on wound healing ofSuprathel in partial-thickness burn injuries. 2008;87(1):56-63. 1987;94(3):442-443. Int Wound J. Chalmers RT, Darling Iii RC, Wingard JT,et al. 2005;41(5):837-843. According to the manufacturer, TheraSkin is designed to promote wound healing by providing cellular and extracellular components with growth factors, cytokines and collagen and to be a natural barrier to infection. Ann Plast Surg. Superior capsule reconstruction to restore superior stability in irreparable rotator cuff tears: A biomechanical cadaveric study. Available at: http://www.teibio.com/SurgiMend.aspx. Maxson S, Lopez EA, Yoo D, et al. Arthroscopic stabilization of acromioclavicular joint dislocation using the AC graftrope system. 2011;40(3):238-243. 2016;29(6):443-50. Transfusion. Fischel RJ, McKenna RJ Jr. 2008;51(5):263-266. Int Wound J. After hemostasis, the membrane was applied to the wound with an outer layer dressing of fatty gauze, bridal veil, absorptive gauze and an ACE wrap. This retrospective intent-to-treat (ITT) matched-cohort study analyzed the full Medicare claims data-set from 2011 to 2014. Canadian Agency for Drugs and Technologies in Health (CADTH).