These investigators hypothesized that processing methodologies, dehydration, and hypothermic processing and storage of amniotic tissues would affect overall quality of wound healing; they compared dehydrated amnion/chorion (dHACM) grafts to a novel HSAM graft in a full-thickness rat wound model. It is an absorbable implant that provides a non-constricting, protective encasement for injured tendons and is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan. Patients treated with Suprathel reported better overall scar quality (p < 0.001). Site-specific rectocele repair with dermal graft augmentation: Comparison of porcine dermal xenograft (Pelvicol) and human dermal allograft. 2014;34(2):161-163. Do fibrin sealants impact negative outcomes after robot-assisted partial nephrectomy? Although rates can be measured comparatively using EMR data by creating treatment groups, absolute rates were far lower than those reported in prospective trials because it was hard to capture outcomes of patients transferred to other facilities in which procedures took place. According to the manufacturer, Talymed is similar to Oasis Wound Matrix, Integra Flowable Wound Matrix, and PriMatrix Dermal Repair Scaffold, but is created from a different source and has a different mechanism of action. Quintessence Int. Sports Med Arthrosc Rev. The study focused on the need for subsequent grafting, healing time, patient pain level, hypertrophic scarring and rate of infection. Accessed December 15, 2008. Implant breast reconstruction using acellular dermal matrix. J Wound Care. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Oxygen and wound care - A review of current therapeutic modalities and future direction. REGUaRD is a hydrated acellular (human) dermal allograft matrix used for the treatment of non-healing wounds and bum injuries. London, UK: NICE; January 2018. Eplasty. Moreover, they stated that further research would be needed to compare the use of amniotic allograft tissue injections versus corticosteroid injections head-to-head, and further larger studies, including randomized controlled trials, may elucidate the reasons for these differences. Przegl Lek. 2006;(2):CD002933. A moist wound healing environment allows autolytic dbridement. Zaidi AH, Nathan M, Emani S,et al. Surg Endosc. Am J Obstet Gynecol. Knoll LD. 2020;28(4):526-531. Clin Plast Surg. 1998;134(3):293-300. These products are supplied in single use packaging in sizes ranging from .786 to 486 sq. Placental membrane provides improved healing efficacy and lower cost versus a tissue-engineered human skin in the treatment of diabetic foot ulcerations. Vowden P, Romanelli M, Peter R, Bostrm A,et al. J Burn Care Rehabil. Farr J, Gomoll AH, Yanke AB, et al; ASA Study Group. Int Wound J. BJOG. Steinberg JS, Edmonds M, Hurley DP Jr, King WN. 2009;67(11):2550-2551. Arthroscopic rotator cuff augmentation: Surgical technique using bovine collagen bioinductive implant. 2008;4(3):195-200. Lopez-Monclova J, Targarona E, Balague C,et al. Preliminary results of arthroscopic superior capsule reconstruction with dermal allograft. 2010;81(2):237-244. In an animal model, ProLayer Acellular Dermal Matrix (ADM) was implanted into 12 rats. The product is intended to be used by physicians for homologous uses of the skin and integumentary system. Wound Repair Regen. StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat), for topical use. 2006;56(1):22-25. Newton DJ, Khan F, Belch JJ, et al. 2017;29(10):311316. Used as an anatomical barrier or wrap in a variety of orthopedic applications. It is packaged as a 200 mg, acellular human placental-derived allograft in a vial which is contained in a peel pouch placed in an outer box. Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction:A prospective comparative study. Hotta SS, Holohan TV. 2005;140(6):549-560; discussion 560-562. Long-term patients reported higher satisfaction with ReCell donor site outcomes compared with the Controls. Throughout the treatment period, the average pain level was 1.9 on a 10-point scale. Restorigin Amniotic Fluid Therapy (AFT) (Parametrics Medical) is an amniotic fluid product that is derived from donated human birth tissue and fluid. J Wound Care. Burns. 2015;9(4):460-468. ANZ J Surg. 510(k) Summary. Wounds. Ryan CM, Schoenfeld DA, Malloy M, et al. Burns. 2013;(10):450-455. Baltimore, MD: CMS;May 13, 2019. Spine (Phila Pa 1976). Clarke S, Hagberg W, Kaufmann RA,et al. J Hip Preserv Surg. 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. 2019;17(2):131-141. WoundFix XPlus Membrane and BioWound XPlus Membrane are supplied in single-use packaging, in 6 sq. These findings should not be generalized to other products or approaches that deliver topical oxygen or other types of wounds. 15. 2020;17(4):966-973. Diabetic Ulcer Study Group. Diaz JJ Jr, Guy J, Berkes MB, et al. 2018;22(4):e2018.00057. (2015) examined planned interim data of a prospective, randomized, double-blind multi-center study comparing the clinical efficacy of the TransCu O2 device (EO2 Concepts) to standard moist wound therapy (MWT). De Angelis N, Felice P, Pellegrino G,et al. Giordano S, Schaverien M, Garvey PB, et al. 2017;29(5):140-146. 2011;25(11):3526-3530. Adv Skin Wound Care. 2009;22(2):68-71. 2014;24(12):2014-2020. Subjects that failed these criteria were removed from the study. 2009;99:301-305. Plast Reconstr Surg. Resource Type: Patient Education Animations. 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. 2010;37(3):602-605. Cochrane DatabaseSyst Rev. Mundy L, Parrella A. Apligraf (R): For the treatment of diabetic foot and venous leg ulcers. J Thorac Cardiovasc Surg. Patel KM, Bhanot P. Complications of acellular dermal matrices in abdominal wall reconstruction. 65780 Ocular surface reconstruction; amniotic membrane transplantation; multiple layers. Aetna Inc. and its subsidiary companies are not responsible or liable for the content, accuracy, or privacy practices of linked sites, or for products or services described on these sites. 2018;35(3):357-365. Acellular dermal matrices in abdominal wall reconstruction:A systematic review of the current evidence. A non-contact video analysis permitted normalization of stretch within the repair region. 2012;32(1):1-14. Scott JD, Cobb WS, Carbonell AM,et al. Centers for Medicare & Medicaid Services (CMS). 2012;39(2):167-175. Guiding practice improvements in pediatric surgery using multidisciplinary clinical pathways. The authors stated that this study was limited by its retrospective design; potential selection bias was inherent to a retrospective study. Int Wound J. The surgeon then thaws the product and stretches it over a burn site. Reconstruction of intraoral oncologic surgical defects with Integra bilayer wound matrix. Eaglstein WH, Falanga V. Tissue engineering for skin: An update. Surg Neurol. The future of recombinant growth factors in wound healing. Bello YM, Falabella AF, Eaglstein WH. XCellerate Amniotic Membrane Allograft delivers cytokines, proteins and growth factors to help regenerate soft tissue. PDF Cigna Medical Coverage Policy - AAPC Muscle Nerve. 2006;192(6):705-709. Rice JB, Desai U, Ristovska L, et al. This ECM includes growth factors, fibronectin, laminin, hyaluronic acid, proteoglycans, and other proteins. Lesher AP, Curry RH, Evans J, et al. This study provided no data on the use of allogeneic amniotic tissue and fluid after plantar fasciitis debridement. Holmes et al (2018) noted that early excision and autografting are standard of care (SOC) for deeper burns; however, donor sites are a source of significant morbidity. 2013;(8):CD009099. Early report of a randomized comparative clinical trial of Strattice reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias. Santema TB, Poyck PP, Ubbink DT. DermACELL:A novel and biocompatible acellular dermal matrix in tissue expander and implant-based breast reconstruction. 2011;56(10):1170-1176. and 5/box); and 10 cm x 15 cm (1 ea. Diabetes Care. Acellular nerve allografts in peripheral nerve regeneration: A comparative study. 2017;224(3):341-350. 2012;16(3):201-6. doi: Christoforidis D, Etzioni DA, Goldberg SM,et al. It is used in women and tendon coverage. Treatment of a persistent iatrogenic cerebrospinal fluid-pleural fistula with a cadaveric dural-pleural graft. Enrollment was carried out with a controlled strategy--sampling chart--that allowed homogeneous groups (ReCell and skin grafting) for age, gender, type of burns and TBSA. Am Surg. Furthermore, these researchers did not measure the duration of therapy in minutes or hours. Talymedwas cleared for marketing under the 510(k) process (K102002) in July 2010 for "the management of wounds including: diabetic ulcers; venous ulcers; pressure wounds; ulcers caused by mixed vascular etiologies; full thickness and partial thickness wounds; second degree burns; surgical wounds-donor sites/grafts, post-Mohs surgery, post laser surgery, and other bleeding surface wounds; abrasions, lacerations; traumatic wounds healing by secondary intention; chronic vascular ulcers; dehisced surgical wounds.". Caravaggi C, Francesco Grigoletto M, Scuderi N. Wound bed preparation with a dermal substitute (Hyalomatrix PA) facilitates re-epithelialization and haling: Results of a multicenter, prospective, observational study on complex chronic ulcers: The FAST Study. [Use of Permacol in complicated incisional hernia] Chir Ital. Wound Repair Regen. 2017;26(12):2158-2166. Centers for Medicare & Medicaid Services (CMS), Healthcare Common Procedure Coding System (HCPCS). Culligan PJ, Littman PM, Salamon CG,et al. After cohort matching, this data-set was not large enough to conduct this type of sub-analysis; future real-world matched-cohort studies looking at timely surgical intervention and recidivism are needed. Int Wound J. These investigators stated that a large RCT that examines changes in wound area reduction and cytokines in active and sham treatment groups would give clinicians better insights regarding the effect of continuous topical oxygen on and timing and the expression of cytokines. J Wound Care. 2010;18(22):1404-1409. Randomized phase II clinical trial of avotermin versus placebo for scar improvement. Xu H, Sandor M, Qi S,et al. 2020;17(6):1986-1995. In about 7 to 14 days, the TransCyte starts peeling off, and the surgeon trims it away as it peels. Lee G, Lee CK, Bynevelt M. DuraSeal-hematoma: Concealed hematoma causing spinal cord compression. 2020;17(3):547-554. J Foot Ankle Surg. 2006;212(3):258-259. 2013;15(5):628-629. Arthroscopy. XCM Biologic Tissue Matrix is supplied sterile (hydrated) in a foil liner pouch. Narotam PK, Qiao F, Nathoo N. Collagen matrix duraplasty for posterior fossa surgery: Evaluation of surgical technique in 52 adult patients. A single center experience. Adelaide, SA: Royal Australasian College of Surgeons, Australian Safety and Efficacy Registry of New Interventional Procedures - Surgical (ASERNIP-S); updated February 2007. 2002;4(4):252-257. : A systematic review of the literature. Romanelli M, Dini V, Bertone MS. Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. The product is thawed in a sterile gloved hand for 5 minutes and cut and shaped to size prior to application following wound preparation. Of these, 127 patients met standard criteria including a minimum of 6 months follow-up, no previous cervical surgeries, and flexion/extension lateral radiographs. Ultimate tensile failure loads of a human dermal allograft rotator cuff augmentation. Wounds. Comparison of staple-line leakage and hemorrhage in patients undergoing laparoscopic sleeve gastrectomy with or without Seamguard. Arthroscopic superior capsular reconstruction with acellular dermal allograft for the treatment of massive irreparable rotator cuff tears: Short-term clinical outcomes and the radiographic parameter of superior capsular distance. 1998;16(1):11-15. 2014;134(1):53-58. Hirsch RJ, Cohen JL. Wound healing with "spray-on" autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: An open-label randomised controlled trial. Lullove E. A Flowable Placental tissue matrix allograft in lower extremity injuries: A pilot study. At 8 weeks, 85 % of the Control-treated wounds were healed compared with 92 % of the ReCell-treated wounds, establishing the non-inferiority of ReCell treatment for wound healing. 2013;217(4):606-613. London, UK: National Institute for Health and Care Excellence (NICE); 2015. 2009;22(4):161-166. Garramone CE, Lam B. 2007;53(6):16-31. J Craniofac Surg. Hernia. Gilot GJ, Alvarez-Pinzon AM, Barcksdale L, et al. Mallinckrodt Pharmaceuticals. 2015;24(6):261-262, 264-267. Wound Repair Regen. Int Urogynecol J Pelvic Floor Dysfunct. 2022;75:103446. 2005;13(6):463-468. Cytal Burn Matrix is manufactured in multi-layer lyophilized (freeze-dried) sheet configurations. Effectiveness of Suprathel application in partial thickness burns, frostbites and Lyell syndrome treatment. Auzin M, Teune TM, Hogewoning CJ. 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. Stendel R, Danne M, Fiss I, et al. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Int Wound J. These researchers compared fusion success rates and pseudarthrosis results with published data for 3-level anterior cervical constructs including; anterior cervical discectomy and fusion with plating (ACDFP) and anterior cervical corpectomy with and without plating (ACCP, ACC). A draft guideline by the National Institute for Health and Clinical Excellence (NICE) on the use of skin substitutes in the inpatient management of diabetic foot problems stated that the evidence for the clinical effectiveness of wound dressings in treating diabetic foot problems was of low quality and that only low-quality evidence on dermagraft and graftskin demonstrated positive effects on complete wound healing (at least 50 % wound closure). Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. 2012;51(5):669-674. 2018;39(2):261-267. There is a lack of evidence in the peer-reviewed medical literature to support it's clinical effectiveness. J Wound Care. Integra LifeSciences Corp, Plainsboro, NJ. 2009;123(6):1654-1658. Br J Nurs. Narins RS, Bowman PH. surgiGraft serves to act as a tissue barrier/covering or to provide lubrication. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Comparative in vitro biomechanical evaluation of two soft tissue defect products. Rockville, MD: FDA; December 4, 2008. 2012;36(8):1760-1764. The EAC indicated that this model was clinically inappropriate; however, data were unavailable to populate a new model. Source: Calendar Year 2020 Medicare Outpatient Prospective Payment System . Themanufacturer also stated that "SurGraft is minimally manipulated Human Cell Tissue Product (HCT/P) intended for homologous use." 24. J Plast Reconstr Aesthet Surg. Hernia. Aesthet Surg J. Hafner J, Brunner U, Burg G. [Treatment guidelines for venous leg ulcers: Causal therapy initiation and local wound treatment]. Integra LifeSciences Corp, Plainsboro, NJ. An evaluable primary outcome was available for all wounds. Cochrane Database Syst Rev. Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review. Use of a human acellular dermal wound matrix in patients with complex wounds and comorbidities. Wound-related costs and product wastage were lower for CHSA patients relative to both BLCC and DSS patients at all time intervals (p < 0.05). The investigators explained that the therapy, known as continuous diffusion of oxygen (CDO), delivers pure oxygen to the wound at low flow rates, preserves patient mobility, showed significant benefits in animal studies and received FDA clearance in August 2009. Adams CR, Denard PJ, Brady PC, et al. Foreign material erosion after laparoscopic Roux-en-Y gastric bypass: Findings and treatment. 2014;148(4):1370-1378. J Extra Corpor Technol. 2014;7(5):15-8. There is a lack of evidence regarding the effectiveness of Revita. Vendaje is a dehydrated human amniotic membrane consisting of the amnion layer that is sterile for single homologous use. Burns. 2017;224(3):351-361. Gaster, et al. Wainwright D, Madden M, Luterman A, et al. 2019;77(10):2127.e1-2127.e11. Revitalon allografts are supplied in a single-sized package and provided in the following sizes: 1 cm round dot, 2x2 cm, 4x4 cm, and 4x6 cm. Burns. Wound Repair Regen. Munster AM, Weiner SH, Spence RJ. By changing the minimum baseline wound size and run-in rate of wound closure inclusion/exclusion criteria and removing subjects that failed these criteria from the final analysis, the investigators introduced a significant source of bias. Williams LE, Vannemreddy PS, Watson KS, Slavin KV. Pol Przegl Chir. 1990;11(1):7-13. 510k no. Charleston, SC: Innocutis Holdings, LLC; June 2014. Sanchez AR, Sheridan PJ, Kupp LI. Rosen MJ. Hyaluronic acid stimulates human fibroblast proliferation within a collagen matrix. 2007;143(10):1297-1304. REGUaRD (New Life Medical, LLC) is a donated allograft placental membrane tissue. 2009;11(6):584-587. J Shoulder Elbow Surg. 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. Paquette D, Falanga V. Leg ulcers. The control group was 2.75 times more likely to require amputation than the treatment group. Lutz S. Mixed views on wound product. Leng LZ, Brown S, Anand VK, Schwartz TH. #: OF1-000329-en-USVersion: FLanguage: EnglishRevision Date: 02/24/2023 2023 Coding and Reimbursement Guidelines for the AutoCart Procedure Using GraftNet Autologous Tissue Collector & BioCartilage Extracellular MatrixFile Type: Ref. J Wound Care. July 13, 2011. Typical doses range from 0.25 cc to 4.0 cc, depending on the size, depth and type of wound. 2018;15(5):731-739. Laparoscopic repair of parastomal hernia using a porcine dermal collagen (Permacol) implant. National coverage determination (NCD) for blood derived products for chronic non-healing wounds (270.3). Shirzadeh A, Rahpeyma A, Khajehahmadi S. A prospective study of chin bone graft harvesting for unilateral maxillary alveolar cleft during mixed dentition. Failure of artelon interposition arthroplasty after partial trapeziectomy:A case report with histologic and immunohistochemical analysis.