Am J Rhinol. Singh et al conducted a single center prospective randomized clinical trial in India consisting of 30 patients with ulcers undergoing STSG. 2013;23(1):e38-e40. AmnioRepair is indicated for use as a biological barrier or wound cover. Carlson M, Faria K, Shamis Y,et al. Surgery. J Oral Maxillofac Surg. 2018;34(6):1764-1773. 2012;130(5 Suppl 2):194S-202S. Int J Low Extrem Wounds. 2012;19(3):288-294. 2002;11(1):20-24. Am J Surg. 2009;8(1):11-18. [website]. Surgeon-controlled study and meta-analysis comparing FlexHD and AlloDerm in immediate breast reconstruction outcomes. Stilwell R, Delaney R. The biomechanics of ProLayer acellular dermal matrix: Biocompatibility study. London, UK: NICE; January 2018. Eaglstein WH, Iriondo M, Laszlo K. A composite skin substitute (graftskin) for surgical wounds. The investigators cited four studies (i.e., Saleh et al, Singh et al, Zidan et al, and Loefebellian et al) comparing human amniotic membrane with routine dressings for split-thickness skin grafts (STSGs) with primary outcomes measured as wound healing and infection rate. OASIS wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous aetiology. Smart NJ, Velineni R, Khan D, Daniels IR. Dermal regeneration template (Integra) for deep hand burns. 2 configurations available: Ambient temperature (Viaflow) and Cryopreserved (Viaflow C), 5-year shelf life at ambient temperature (Viaflow), The use of porcine-derived decellularized collagen products (e.g., Collamend, Cuffpatch, Pelvicol. #: DOC1-001032-en-USVersion: ALanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for FastThread Interference ScrewsFile Type: Ref. An evaluable primary outcome was available for all wounds. Patients were placed into three groups where post-excision of donor sites, included group A covered with allogenic HAM, group B with polyurethane (PU) foam and group C with PU foil and consecutive paraffin gauze. There was an increase from baseline to week 1 in transforming growth factor (TGF) (p =0.008), tumor necrosis factor (TNF) (p =0.014), vascular endothelial growth factor (VEGF) (p =0.008), platelet derived growth factor (PDGF) (p =0.087), and insulinlike growth factor1 (IGF1) (p =0.058); baseline to week 2 in TGF (p =0.010), VEGF (p =0.051), and interleukin-6 (IL6) (p =0.031); and baseline to week 3 with TGF (p =0.055) and IL6 (p =0.054). Efficacy of interference screw and double-docking methods using palmaris longus and GraftJacket for medial collateral ligament reconstruction of the elbow. Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Horizon Scanning Prioritising Summary - Volume 7. Hyalomatrix PA in burn care practice: Results from a national retrospective survey, 2005 to 2006. Ann Surg. Raghoebar GM, Schortinghuis J, Liem RS, et al. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Treatment of fistula-in-ano using a porcine small intestinal submucosa anal fistula plug. Freymiller EG, Aghaloo TL. Surg Neurol. J Am Podiatr Med Assoc. 510(k) Summary. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2004. Eligible children were enrolled and randomized, stratified by burn thickness, to be dressed in an ointment-based dressing or Mepitel Ag. Eur J Cardiothorac Surg. Int Rev Modern Surg, February 2002. Mid-term outcome of laparoscopic sacrocolpopexy with anterior and posterior polyester mesh for treatment of genito-urinary prolapse. Request to establish a new Level II HCPCS code to identifyCygnus Matrix. Relese (StimLabs, LLC) is a sheet skin substitute product comprised of dehydrated human amniotic membrane that contains non-viable cells and is intended for use as a selective barrier and to protect wounds from the surrounding environment for chronic and acute wounds including dermal ulcers and other defects. 2012;25(6):253-260. Skovgaard C, Holm B, Troelsen A,et al. Wounds. Revita allograft is intended to be used as a wound covering, or barrier membrane, over chronic and acute wounds, including dermal ulcers or defects. The graft can be rehydrated in-situ with sterile water or 0.9% saline if desired. A clinical trial of Integra Template for diabetic foot ulcer treatment. Chronic ulcers: MATRIDERM() system in smoker, cardiopathic, and diabetic patients. Health Technology Review No. J Burn Care Rehabil. 2011;9:126. Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled multi-centre clinical trial. 1990;211(6):676-679. Request to establish one new level II HCPCS code to identifyliquid human amnion allografts, Trade Names: PalinGen Flow and PalinGen SportFlow. Ho C, Tran K, Hux M, et al. Zelen CM, Orgill DP, Serena TE, et al. 2011;11:e10. Of these, 127 patients met standard criteria including a minimum of 6 months follow-up, no previous cervical surgeries, and flexion/extension lateral radiographs. 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). Microsurgery. Diabetic foot problems. Apligraf in the treatment of neuropathic diabetic foot ulcers. Procenta is supplied in a single use vial containing one 200 mg placental allograft, providing coverage for up to a 6 cm2 wound surface area. Chen J, Lee S, Lui T,et al. Gabriel A, Gollin G. Management of complicated gastroschisis with porcine small intestinal submucosa and negative pressure wound therapy. J Am Coll Surg. 2004;64(2):282-286. 2008;122(4):1206-1213. TheraSkin contains: 1) both collagen and elastin which provide structural support and resilience, 2) a compliment of growth factors to assist healing, 3) multiple cytokines that assist in epithelialization and modulate the proliferation and differentiation of epithelium, and 4) structures that allow phagocytosis of bacteria without requirement of antibody production. The efficacy and safety of Grafix() for the treatment of chronic diabetic foot ulcers: Results of a multi-centre, controlled, randomised, blinded, clinical trial. Two alternative dural sealing techniques in posterior fossa surgery: (Polylactide-co-glycolide) self-adhesive resorbable membrane versus polyethylene glycol hydrogel. J Thorac Cardiovasc Surg. BioCartilage Extracellular Matrix Helping Surgeons Treat Their Patients Better - Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. Available at: http://www.cookbiotech.com/corp/news/040903.html. 2022a;10(12):e4707. Plast Reconstr Surg. Average time to healing was 13.7 days for 90% epithelialization with 11.9 days for pediatric patients versus 14.7 days for adults. Accessed January 21, 2022. 2014;41(4):330-336. TransCyte is also intended for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. Ann Plast Surg. Use of small intestinal submucosa graft for the surgical management of Peyronie's disease. Clinical Practice Guideline No. Application Summaries and Coding Recommendations. Bronchoscopic removal of staple-line reinforcement material. Functional properties of a purified reconstituted bilayer matrix design support natural wound healing activities. Ann Plastic Surg. 2014;23(10):465-474. DiDomenico LA, Orgill DP, Galiano RD, et al. West Lafayette, IN: Cook Biotech; April 9, 2003. Plast Reconstr Surg. A biomechanical cadaveric study comparing superior capsule reconstruction using fascia lata allograft with human dermal allograft for irreparable rotator cuff tear. Foreign body reaction to acellular dermal matrix allograft in biologic glenoid resurfacing. Int Wound J. Rice JB, Desai U, Ristovska L, et al. Technology Assessment Program: Skin substitutes for treating chronic wounds. 2005;30(2):380-389. Semin Pediatr Surg. Efficacy of medical grade honey against multidrug-resistant organisms of operational significance: Part I. J Trauma Acute Care Surg. Biehl RC, Moore RD, Miklos JR,et al. Rihn JA, Patel R, Makda J,et al. 2020a;28(1):81-89. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Apte RS, Solomon SD, Gehlbach P. Acute choroidal infarction following subcutaneous injection of micronized dermal matrix in the forehead region. J Burn Care Rehabil. The quantity and size of the product used vary based upon wound size and physician recommendation. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy:A single-blinded, randomized controlled trial. Resistance to gapping as measured through normalized stiffness (N/mm/mm) was greater for the Tisseel group, Evicel group, and DuraSeal group versus the no-glue group only. 2009;16(4):324-329. Sultan AA, Samuel LT, Roth A, et al. Ann Plast Surg. AHCPR Pub. Question - Biocartilage | Medical Billing and Coding Forum - AAPC Ferguson MW, Duncan J, Bond J,et al. Bowers CA, Brimley C, Cole C, et al. sizes. Hernia. Bilayer Matrix Wound Dressing. Synovis Surgical Innovations. Specifically, the products three layers of ovine-derived ECM contain more than 150 essential ECM proteins which include structural proteins, adhesion proteins, and signaling proteins. Another drawback was insufficient data were available in the EMRs to factor limb vascularity and HbA1c into the matching scheme. The vial is packaged in a foil pouch and then terminally sterilized using e-beam irradiation. 2022b. Plast Surg Nurs. 2011;17(4):CS47-CS51. Experience with the use of apligraf to heal complicated surgical and nonsurgical wounds in a private practice setting. A matched-pair, randomized study evaluating the efficacy and safety of Acticoat silver-coated dressing for the treatment of burn wounds. (2015) found a lack of statistical significance for their primary endpoint, complete wound closure by 12 weeks. However, long-term aesthetic and functional outcomes of graft scars may be poor. Madison, WI: Mallinckrodt; revised June 2021. The use of Biobrane() as a delivery method for cultured epithelial autograft in burn patients. SurGraft TL is a triple-layer amniotic tissue allograft produced from donated human amniotic membrane. J Neurosurg. Objective scar characteristics (elasticity, transepidermal water loss, hydration, and pigmentation) and subjective assessments (Patient and Observer Scar Assessment Scale) were measured at 1 month post burn. Platelet gel for healing cutaneous chronic wounds. Smart NJ, Marshall M, Daniels IR. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. 2009;2(6):299-302. Microsurgery. Medtech Innovation Briefing [MIB139]. Still J, Glat P, Silverstein P, et al. Riboh JC, Saltzman BM, Yanke AB, Cole BJ. London, UK: BMJ Publishing Group;September 2010. J Wound Care. Brinster DR, Patel JA. A prospective, randomized, multicenter, controlled evaluation of the use of dehydrated amniotic membrane allograft compared to standard of care for the closure of chronic diabetic foot ulcer. 2009;73(2):245-250. Eur J Obstet Gynecol Reprod Biol. Vloemans AF, Hermans MH, van der Wal MB, et al. The authors stated that the ReCell procedure took longer than skin grafts, mainly due to the time required by trypsin to digest intercellular bonds (20 mins). Most notably, it will be used for wounds resulting from chronic diabetic foot ulcers. Greenwood JE. 2011;8(23):228-235. Centers for Medicare & Medicaid Services (CMS). 2019;45(4):772-782. Comparative analysis of urinary incontinence severity after autologous fascia pubovaginal sling, pubovaginal sling and tension-free vaginal tape. Bradley M, Cullum N, Nelson EA, et al. 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). 2019;54(7):1391-1396. Werber and Martin (2013) reviewed the background information and previous clinical studies that considered the use of allogeneic amniotic tissue and fluid (granulized amniotic membrane and amniotic fluid) in the treatment of chronic diabetic foot wounds. 2004;29(24):2861-2867; discussion 2868-2869. No. Denard PJ, Brady PC, Adams CR, et al. Plast Reconstr Surg. VIM human amniotic membrane allograft originates from human tissue and is for homologous use. Burns Trauma. Bou Monsef J, Buckup J, Waldstein W,et al. Patel KM, Bhanot P. Complications of acellular dermal matrices in abdominal wall reconstruction. Lin Q, Rosines E, Taylor BM, Clagett J. TheraSkin analysis, stage 1 findings: Identification of key growth factors, cytokines and collagen in TheraSkin. A novel flowable tissue matrix allograft, derived from human placental connective tissue, has recently been made available for minimally invasive treatment of damaged or inadequate tissue (PX50, Human Regenerative Technologies LLC, Redondo Beach, CA). 2015;30(4):351-354. Connolly RJ. Patients were excluded if they were diabetics, were smokers, had clinical signs of wound infection, anankle brachial pressure index less than 0.06, had necrotic tissue on the wound bed, had known allergy to the treatment products or were unable to deal with the protocol. There were no statistically significant differences in the distribution of CCI, age, sex, and region among cohorts. All-arthroscopic patch augmentation of a massive rotator cuff tear: Surgical technique. HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers:A prospective, multicenter, controlled, randomized clinical trial. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. NNT point estimates of clinical efficacy were 2 for Talymed, 5 for Oasis, and 6 for Apligraf; 95 % CIs ranged from 2 to 8 for Talymed, 3 to 24 for Apligraf, and 3 to 39 for Oasis. Gerdisch MW, Boyd WD, Harlan JL,et al. PDF Skin Substitute Grafts Coding Reference Guide - Zimmer Biomet An in vitro study of the anti-microbial efficacy of a 1% silver sulphadiazine and 0.2% chlorhexidine digluconate cream, 1% silver sulphadiazine cream and a silver coated dressing. Transdermal oxygen does not improve sternal wound oxygenation in patients recovering from cardiac surgery. Colorectal Dis. A randomized controlled single-blind study demonstrating superiority of amniotic suspension allograft injection over hyaluronic acid and saline control for modification of knee osteoarthritis symptoms. Thavarajah D, De Lacy P, Hussain R, Redfern RM. He C, Hughes MA, Cherry GW, Arnold F. Effects of chronic wound fluid on the bioactivity of platelet-derived growth factor in serum-free medium and its direct effect on fibroblast growth. Int J Low Extrem Wounds. Arthrex Amnion matrix; ArthroFlex . Wounds. The health economic impact of living cell tissue products in the treatment of chronic wounds: A retrospective analysis of Medicare claims data. Kimmel HM, A comparison of continuous oxygen therapy to topical oxygen. ArthroCell is a moldable viable cellular allogeneic bone matrix derived from bovine bone marrow. -load sharing device. Synovis Surgical Innovations, St. Paul MN. Repriza is supplied sterile and ready to use in two sizes: 4 x 12 cm and 6 x 16 cm. There were no differences in quantitative cultures in healers and non-healers. After undergoing cardiopulmonary bypass, a total of 30 patients randomly received: In a prospective, controlled study, Blackman et al (2010). A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers. According to the 510(k) letter to the manufacturer, it is specifically indicated for plastic and reconstructive surgery, muscle flap reinforcement, hernia repair (e.g., abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias), reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including re-inforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Ann Plast Surg. Robson MC, Mustoe TA, Hunt TK. DeCarbo WT. Growth factors and wound healing. Surg Technol Int. 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. 2013;4:2041731413502663. Trop M, Novak M, Rodl S, et al. Acta Otorhinolaryngol Ital. a 3D+t single plane illumination microscopy (SPIM) dataset consisting of 192 time-points. Prophylactic administration of avotermin for improvement of skin scarring: Three double-blind, placebo-controlled, phase I/II studies. 2014;16(1):R47. Danish SF, Samdani A, Hanna A, et al. Carter MJ, Fylling CP, Li WW,et al. Lee K, Goodman SB. An autologous epidermal equivalent tissue-engineered from follicular outer root sheath keratinocytes is as effective as split-thickness skin autograft in recalcitrant vascular leg ulcers. 2002;97(5):1212-1216.2: Bowers CA, Brimley C, Cole C,et al. Letendre S, LaPorta G, O'Donnell E,et al. Rahmanian-Schwarz A, Beiderwieden A, Willkomm LM,et al. July 13, 2011. J Oral Maxillofac Surg. The proprietary process of recovering Pro3-Cord and Pro3-Placenta preserves the natural healing properties to facilitate regenerative healing as opposed to scar-mediated healing. Hansbrough JF, Mozingo DW, Kealey GP,et al. Diabetic foot problems: Evidence Update. Yeen WC, Faber C, Caldeira C,et al. TheraSkin is marketed by Soluble Systems and tissue is provided by the Skin and Wound Allograft Institute (SWAI, Virginia Beach, VA), a wholly owned subsidiary of LifeNet Health, Inc. TheraSkin is cryopreserved human skin procured from consented and screened tissue donors that is used to provide a physiological and mechanical barrier that reduces environmental contamination and assists in the promotion of granulation tissue and epithelialization. 510(k) Summary. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. Kissane NA, Itani KM. Nilsson A, Wiig M, Alnehill H,et al. Public Meeting for Code Applications for Non-Drug and Non-Biological Items and Services Submitted to CMS 2nd 2021 Biannual HCPCS Coding Cycle. Dis Colon Rectum. No. A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: Positive clinical outcomes of viable cryopreserved human placental membrane. Przegl Lek. Lullove EJ, Liden B, Winters C, et al. 2011;156(2):217-222. Accessed July 7, 2009. 2011;15(4):433-437. Narotam PK, Reddy K, Fewer D, et al. The 23 eligible participants (11 randomized to the HSA, 12 to the HFDS group) were recruited from two hospital-based outpatient wound care centers. Br J Plast Surg. Wallen J, Rao V. Extensive tricuspid valve repair after endocarditis using CorMatrix extracellular matrix. 1998;25(3):397-405. 2007;(1):CD001836. Salomon LJ, Detchev R, Barranger E,et al. Marston WA, Lantis JC, 2nd, Wu SC, et al. Accessed on February 11, 2010. Rockville, MD: AHRQ; January 28, 2019. 2011;92(1):e17-e18. Weindl G, Schaller M, Schfer-Korting M, et al. According to the manufacturer, Cytalcontains a unique epithelial basement membrane which is known to be composed of several types of collagen, adhesion proteins, glycoproteins, and other elements of an extracellular matrix which all act synergistically in supporting natural tissue healing. PuraPly Am is a double-layer fenestrated and cross-linked sheet of porcine collagen, coated with polyhexamethylene biguanide hydrochloride (PHMB) to resist microbial colonization and reduce microbial penetration within the matrix. Tong E, Martin F, Shelley O. Ostomy Wound Manage. Epstein NE. Clin Biomech (Bristol, Avon). The investigators found that time to re-epithelialization was not different between the groups (12 days; p = 0.75). Plast Reconstr Surg. 2004;52(2):188-194. 2009;111(2):380-386. Spine (Phila Pa 1976). Biologic mesh use practice patterns in abdominal wall reconstruction:A lack of consensus among surgeons. The investigators note that burn depth was assessed clinically only by experienced burn physicians. ProMatrX ACF is supplied in liquid form in vials containing 0.25 cc, 0.5 cc, 1 cc, 2 cc, and 4 cc. DermACELL:A novel and biocompatible acellular dermal matrix in tissue expander and implant-based breast reconstruction. Integra LifeSciences Corp. Integra Matrix Wound Dressing [website]. Colorectal Dis. Resource Type: Patient Education Animations. Washburn R, 3rd, Anderson TM, Tokish JM. 2000;105(1):62-65. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2004. Surgenex, LLC, offers SurFactor and NuDyn, which are the same products, marketed under different names. 2011;10(2):80-85. Silver dressings for the treatment of patients with infected wounds:A review of clinical and cost-effectiveness. Plast Reconstr Surg Glob Open. Incidence of complete wound closure at 14 weeks, donor site closure, pain, Health-Related Quality of Life (HRQoL), satisfaction, and safety were assessed in 52 patients. Obstet Gynecol Int. A delayed type of ureteric injury developed after transobturator mesh procedure for massive prolapse. The applicant claims that TruSkin is indicated for patients with acute and chronic wounds, who have limited treatment options and are at great risk for wound-related morbidities and mortality. Reddy M. Pressure ulcers. Gravante G, Di Fede MC, Araco A, et al. Maxson S, Lopez EA, Yoo D, et al. The ReCell was developed for POC preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient's skin to treat up to 80 cm2 of excised burn. Buttressing the staple line in lung volume reduction surgery:A randomized three-center study. Collective capabilities of XCelliStems composition include the following activities within the tissue: binding to existing native ECM material, binding to cells, signaling cell attraction, cell mobility, cell growth, and cell differentiation. Kathju S, Lasko LA, Medich DS. Statistical analysis was performed via analysis of variance followed by Tukey-Kramer post hoc pair-wise comparison when indicated. It is used for the treatment of non-healing wounds and burn injuries. Arthrex coding guides are designed to provide coding, coverage, and reimbursement information to internal and external customers who are involved in coding and reporting provider services. Arch Dermatol. The use of autologous platelet gel to treat difficult-to-heal wounds: A pilot study. Am J Surg. 2014;11(2):122-128. These products are cryopreserved and should be stored frozen at a temperature at -80C +/- 15. Treating providers are solely responsible for medical advice and treatment of members. Deorsola L, Pace Napoleone C, Abbruzzese PA. Repair of an unusual aortic coarctation using an extracellular matrix patch. Proposed decision memo for autologous blood derived products for chronic non-healing wounds (CAG-00190R2). Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). Sepesi B, Moalem J, Galka E,et al. Ryssel H, Andreas Radu C,et al. Surg Neurol Int. 2019b;16(1):122-130. 2011;4(1):29-41. Adv Skin Wound Care. surgiGraft (Synergy Biologics) is a minimally manipulated human amnion-only regenerative extracellular tissue matrix derived from human placental tissue (amniotic tissue) which has been processed into an allograft. Burns. Adv Skin Wound Care. Walters J, Cazzell S, Pham H, et al. Wound Repair Regen. Hu S, Kirsner RS, Falanga V, et al. Int Wound J. Advanced Wound Care Therapies for Non-Healing Diabetic, Venous, and Arterial Ulcers: A Systematic Review [Internet]. Adv Skin Wound Care. Abbasian B, Kazemini H, Esmaeili A, Adibi S. Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats. Technology Report No 52. Khoury WE, Fahim R, Sciulli JM, Ehredt DJ Jr. Management of failed and infected first metatarsophalangeal joint implant arthroplasty by reconstruction with an acellular dermal matrix:A case report. Effectiveness measures were evaluated and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes up to 1 year following treatment. 2015;1-7. Comparison of E-Z Derm and Jelonet dressings for partial skin thickness burns. 2005;79(3):796-800. Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: A pilot study.