1998;134(3):293-300. 2006;10(5):419-425. Voigt J, Driver VR. Vashi C. Clinical outcomes for breast cancer patients undergoing mastectomy and reconstruction with use of DermACELL, a sterile, room temperature acellular dermal matrix. Promogran Matrix wound ressing is indicated for the management of exuding wounds including:diabetic ulcers, venous ulcers, ulcers caused by mixed vascular etiologies, full thickness and partial thickness wounds, donor sites and other bleeding surface wounds, abrasions, traumatic wound healing by secondary intention, and dehisced surgical wounds. Thompson P, Hanson DS, Langemo D, Anderson J. 2008;122(4):1206-1213. Schiariti M, Acerbi F, Broggi M, et al. Langer A, Rogowski W. Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers. 2016;104(7):1495-1503. Skin and Soft Tissue Substitutes - Medical Clinical Policy - Aetna Both cohorts received standard wound care, including surgical debridement, moist wound care, and off-loading. 2017;14(6):1066-1075. Braca JA 3rd, Marzo S, Prabhu VC. Review Body for Interventional Procedures (ReBIP). Baltimore, MD: CMS; June 14, 2006. Full-thickness diabetic foot ulcers greater than 6-weeks duration that extend through the dermis, but without tendon, muscle, joint capsule or bone exposure; Integra Dermal Regeneration Template, Integra Bilayer Matrix Wound Dressing, and Integra Meshed Bilayer Wound Matrix (collagen-glycosaminoglycan copolymers) for the treatment of individuals with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created; Integra Dermal Regeneration Template and Integra Omnigraft Dermal Regeneration Template for the treatment of partial and fullthickness 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. 2006;(2):CD002933. 2003;18(1):12-22. The mean number of TheraSkin allografts required ranged from 1 to 8, with an average of 2.03 ( 1.47) at the 12-week point and an average of 3.23 ( 2.77) at the 20-week point. 1994;57(1)170-173. Rahmanian-Schwarz A, Beiderwieden A, Willkomm LM,et al. J Bone Joint Surg Am. Greenwood JE. They evaluated as primary endpoints of the study the time for complete epithelization (both treated area and biopsy site) as well as aesthetic and functional quality of the epithelization (color, joint contractures). Dermagraft treatment of diabetic ulcers. Arthrosc Tech. PROVANT Wound-Closure System accelerates closure of pressure wounds in a randomized, double-blind, placebo-controlled trial. The role of Apligraf in the treatment of venous leg ulcers. Sari E, Eryilmaz T, Tetik G, et al. TheraSkin (Soluble Systems, Newport News, VA) is a biologically active, cryopreserved human skin allograft with both epidermis and dermis layers. Int Braz J Urol. For example, it may be used to support implants in a defined pocket such as in breast reconstruction, and abdominal wall reconstruction procedures. Case report. Williams LE, Vannemreddy PS, Watson KS, Slavin KV. #: DOC1-001019-en-USVersion: BLanguage: EnglishRevision Date: 02/22/2023 Hammertoe Correction Using DynaNite FlexWire - 2023 Coding and Reimbursement GuidelinesFile Type: Ref. The authors concluded that from their experience with the patients in the present case series, they believed that granulized amniotic membrane and amniotic fluid represents a useful option for the treatment of chronic diabetic foot wounds. 2016;2:CD011255. Some treatment modalities, such as the use of negative pressure wound therapy versus simple bolster dressing, differed between wounds, but no statistical difference was noted between the treatments. 2004;30(5):471-475. is a human cellular and tissue based product donated allograft placental tissue (CMS, 2017). Acta Dermatovenerol Alp Panonica Adriat. Adams JE, Merten SM, Steinmann SP. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Successful treatment of two refractory venous stasis ulcers treated with a novel poly-N-acetyl glucosamine-derived membrane. A total of 82 patients were analyzed in 2 homogeneous groups. FDA approves new medical adhesive to treat burn patients. Tausche AK, Skaria M, Bhlen L,et al. Newport News, VA: Soluble Systems; revised August 10, 2011. Bluebond-Langner R, Keifa ES, Mithani S, et al. 2023 Feb 15 [Online ahead of print]. Cytal Burn Matrix is supplied as: 7 cm x 10 cm fenestrated wound sheet, 1 ea; and 7 cm x 10 cm meshed wound sheet, 1 ea. Silver Spring, MD: FDA; June 15, 2021. J Hand Surg Am. Longaker MT, Chiu ES, Harrison MR, et al. 2020;36 Suppl 1:e3284. Kissane NA, Itani KM. Multi-variate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. Bush J, Duncan JA, Bond JS,et al. Pelvic floor reconstruction with a biological mesh after extralevator abdominoperineal excision leads to few perineal hernias and acceptable wound complication rates with minor movement limitations: Single-centre experience including clinical examination and interview. Actas Dermosifiliogr. J Hand Surg Eur Vol. Center for Medicare and Medicaid Services (CMS). 2011;21(7):579-582. Alvarez OM, Makowitz L, Patel M. Venous ulcers treated with a hyaluronic acid extracellular matrix and compression therapy: Interim analysis of a randomized controlled trial. Efficacy of fibrin sealant (human) (Evicel) in rhinoplasty:A prospective, randomized, single-blind trial of the use of fibrin sealant in lateral osteotomy. 2011;13(6):569-572. A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Ther Umsch. The manufacturer states that it is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds. 2009;9(1):11-14. 2011;8(23):228-235. 2003;12(3):101-107. 2020;17(3):742-752. Repriza is a prehydrated, ready-to-use,acellular dermal matrix derived from human allograft tissue. The specimens were divided into 5 groups. Healthcare Common Procedure Coding System (HCPCS). Technology Appraisal Guidance No. The purpose of the study was to examine whether a single extracellular matrix component, such as hyaluronan (Hyaloskin), can stimulate healing of mixed arterial/venous ulcers or whether a more integrated extracellular replacement that contains multiple active extracellular matrix components is needed. K062915. 2015;19(7):411-417. Cochrane Database Syst Rev. Usefulness of autologous growth factors in orthopaedic surgery. Renuva isintended for the replacement of damaged or inadequate integumental adipose tissue matrix such as facial deformities, craniofacial deformities, breast reconstructions, or for other homologous uses into areas of the body where native fat would exist. Urrea-Botero G. Can continuous diffusion of oxygen heal chronic toe ulcers? Plast Reconstr Surg Glob Open. Additionally, Vende is a structural tissue allograft that is utilized as a skin substituteserving as a protective barrier via resorption into the wound and repairs superficial dermal and soft tissue wounds. surgical technique consisting of debridement and marrow stimulation with application of micronized allograft cartilage matrix (BioCartilage , Arthrex, Naples, FL). Int Wound J. 2008;31(3):297-301. 2019;28(Sup5):S4-S10. Facial Plast Surg. J Am Col Certif Wound Spec. Huang YC, Jazayeri L, Le W, Yao J. 2003;26(6):1701-1705. Wollina U, Schmidt WD, Krnert C,et al. In addition, the draft guideline stated that the use of skin substitute treatments for the inpatient management of diabetic foot problems should only be offered as part of a clinical trial (NICE, 2011). Adelaide, SA: Royal Australasian College of Surgeons, Australian Safety and Efficacy Registry of New Interventional Procedures - Surgical (ASERNIP-S); updated February 2007. Mari FS, Masoni L, Cosenza UM,et al. 2013;205(2):220-230. 2013;47(6):451-453. AmnioMatrix Human Amniotic Suspension Allograft | WoundSource Biologic meshes are not superior to synthetic meshes in ventral hernia repair: An experimental study with long-term follow-up evaluation. This product is intended to function as a barrier ad provide protective coverage from the surrounding environment for acute and chronic wounds. Janis JE, O'Neill AC, Ahmad J, et al. Burn News. The study, not industry-sponsored, was designed and conducted as a prospective, head-to-head, single-site, randomized clinical trial to assess differences in healing rates, adverse outcomes, and treatment costs. Thekkinkattil DK, Botterill I, Ambrose NS,et al. Carbohydr Res. Surgenex, LLC, offers SurFactor and NuDyn, which are the same products, marketed under different names. J Drugs Dermatol. 2005;14(4):155-160. Santiago GF, Bograd B, Basile PL, et al. Thicknesses differ between Pro3-Placenta and Pro3-Cord for unique application use. Humanitarian Device Exemption No. Uhlig C, Rapp M, Hartmann B, et al. Chen SG, Tzeng YS, Wang CH. AETMIS 06-08. Clin Podiatr Med Surg. 2014;12(4):296-303. Collagen fistula plug for the treatment of anal fistulas. A prospective comparison of diabetic foot ulcers treated with either a cryopreserved skin allograft or a bioengineered skin substitute. J Burn Care Res. Decellularization of human dermis using non-denaturing anionic detergent and endonuclease: A review. 2013;20(2):176-182. Another drawback was that the database did not include specific measures of vascularity or hemoglobin A1c (HbA1c), and this may have contributed to the differences in the healing rates observed. The authors concluded that avoidance of gapping at the nerve repair site is crucial in achieving successful nerve regeneration. This product is fully resorbable and does not require removal from the wound bed. These are intended for use as a wound covering, surgical covering, wrap or barrier, application to partial-and full-thickness, acute and chronic wounds such as, traumatic and complex wounds, burns, surgical and Mohs surgery sites and diabetic, venous, arterial, pressure and other ulcers, including with exposed tendon, muscle, bone, or other vital structures. 2011;(7):CD003091. Children randomized to standard ointment dressings were significantly less likely to require 4 or more burn clinic visits than those in the Mepitel Ag (4 % versus 27 %; p = 0.004). 2015;29(7):2006-2012. Stockholm, Sweden: The Swedish Council on Health Technology Assessment (SBU); 2010. Int J Burns Trauma. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS). 2006;60(1):17-22. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Neurosurgery. PDF Skin Substitute Grafts Coding Reference Guide - Zimmer Biomet 1998;101(7):1891-1903. Wasiak J, Cleland H. Burns (minor thermal). It is intended to provide a protective barrier while providing a regenerative tissue matrix with anti-inflammatory, anti-scarring and anti-microbial properties to facilitate healing of chronic, non-healing wounds and burns. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Perit Dial Int. Radu CA, Gazyakan E, Germann G,et al. The authors concluded that these findings demonstrated that wound-related costs, product waste, amputations, and frequency of applications are lower for CHSA than DSS. The efficacy and safety of Grafix() for the treatment of chronic diabetic foot ulcers: Results of a multi-centre, controlled, randomised, blinded, clinical trial. Plast Reconstr Surg. 2018;26(2):70-74. 2008;6(1). Symphony is a bioengineered skin substitute made up of an extracellular matrix (ECM) and hyaluronic acid (HA). Lawin PB, Silverstein P, Still JM Jr. E-Z Derm a porcine heterograft material. 2018;27(9):s30-s45. Centers for Medicare & Medicaid Services (CMS). In addition to this study, additional weak . Ann Thorac Surg. Adv Skin Wound Care. Karr JC, Taddei AR, Picchietti S,et al. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2013. 2015;40(9):1009-1012. 2017;25(1):145-149. 2007;21(5):615-618. Morgan DM, Dunn RL, Fenner DE, et al. Dara E, Coutant C, Rouzier R,et al. The use of human amnion/chorion membrane in the clinical setting for lower extremity repair:A review. Apligraf or the sheet form of EpiFix (Q4131) may be considered medically necessary for the following applications: Nelson EA, Bradley MD. #: DOC1-000543-en-USVersion: ELanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for CuffMend Rotator Cuff Repair Augmentation SystemFile Type: Ref. Bakri MH, Nagem H, Sessler DI, et al. InnovaMatrix AC is the first Food and Drug Administration cleared medical device sourced from pig placenta. OASIS wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous aetiology. A retrospective study evaluating the use of Permacol surgical implant in incisional and ventral hernia repair. Evans JM, Andrews KL, Chutka DS, et al. Li HY, Xiao SC, Zhu SH,et al. Eplasty. 1992;18(2):145-148. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. EpiFix for chronic wounds. Kirsner RS, Eaglstein WH, Kerdel FA. 2005;66(6):1314-1318. de Boer TA, Gietelink DA, Hendriks JC, Vierhout ME. 1993;25(6):535-538. 1995;16(3 Pt 1):331-333; discussion 333-334. There were no significant differences in stiffness between any of the nerve glue groups. Arch Surg. For the temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in persons who require such a covering before autograft placement; For the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. 1998;39(6):1007-1010. Chen J, Lee S, Lui T,et al. J Foot Ankle Surg. In: BMJ Clinical Evidence. Pain ratings were significantly reduced during the first 5 days after burn in the Suprathel group in all patients (p = 0.03) and a pediatric subgroup (p < 0.001). School of Health and Related Research (ScHARR), University of Sheffield. Study designs and wound characteristics varied. J Clin Aesthet Dermatol. Skin substitutes for treating chronic wounds. Derwin KA, Baker AR, Spragg RK,et al. Plast Reconstr Surg. Version 2.0 Final. Lipsky BA, Berendt AR, Cornia PB, et al. It is comprised of native human amnion and chorion consisting of collagen types I, III, IV, V, VI, laminin, fibronectin, nidogen, and proteoglycans. J Wound Care. Complications following decompression of Chiari malformation Type I in children: Dural graft or sealant? Female Pelvic Med Reconstr Surg. REGUaRD (New Life Medical, LLC) is a donated allograft placental membrane tissue. 1998;25(3):397-405. 2005;26(4):344-347. #: OF1-000345-en-USVersion: FLanguage: EnglishRevision Date: 02/27/2023 2023 Coding and Reimbursement Guidelines for the Syndesmosis TightRope Implant SystemFile Type: Ref. A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients. 2005;41(5):837-843. It can also be used as a temporary covering for some burn wounds that heal without autografting. Int J Low Extrem Wounds. Dass AK, Lo TS, Khanuengkitkong S, Tan YL. Oasis Burn Matrix: HCPCS codes not covered for indications listed in the CPB: Q4103: Oasis Burn Matrix, per sq cm : ICD-10 codes not covered for indications listed in the CPB (not all inclusive): T20.011A - T25.799S: Burns: ParietexComposite (PCO) Mesh: HCPCS codes not covered for the indications listed in the CPB: C1781: Mesh (implantable) Arthrex - Arthrex Amnion Matrix 2007;177(1):192-195. 2021;35(9):5173-5178. Patel MR, Stadler ME, Snyderman CH, et al. Trop M, Novak M, Rodl S, et al. Novartis Pharmaceuticals Corporation. Int Wound J. Drugs, Biologicals and Radiopharmaceuticals. 2011;8(2):177-183. Peled ZM. 2002;23(5):311-317. Obes Surg. Arch Gynecol Obstet. 2011;156(2):223-227. No authors listed. Are biologic grafts effective for hernia repair? Trends Biotechnol. This human-derived product offers many advantages in wound healing. Each allograft is restricted to homologous use in procedures on a single occasion by a licensed physician or surgeon. Surg Neurol Int. 2014;18(2):221-230. The donor human skin is processed and then freeze-dried to remove cells while maintaining the collagen, elastin, and proteoglycans. 2008;61(5):494-499. Int Wound J. The use of a bioactive skin substitute decreases length of stay for pediatric burn patients. 2016;28(4):119-125. Moreover, these researchers stated that further investigation is needed to examine the effect of ASCS+compression on wounds evaluating the healing outcomes and the impact that the decrease in wound size has on pain and cost-effectiveness of the treatment. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. 1993;128(11):1227-1233. Arch Orthop Trauma Surg. 2020;17(6):1986-1995. 2019;31(10):246-251. Microsurgery. Alicuben ET, Worrell SG, DeMeester SR. Impact of crural relaxing incisions, Collis gastroplasty, and non-cross-linked human dermal mesh crural reinforcement on early hiatal hernia recurrence rates. There was strong evidence of tissue incorporation and blood vessel infiltration. Package Insert. Eplasty. 2019;47(8):1901-1908. van der Meijden OA, Wijdicks CA, Gaskill TR, et al. Center for Medicare and Medicaid Services (CMS). Jeon H, Kim J, Yeo H, et al. Clarke S, Hagberg W, Kaufmann RA,et al. Efficacy of interference screw and double-docking methods using palmaris longus and GraftJacket for medial collateral ligament reconstruction of the elbow. The control group was 2.75 times more likely to require amputation than the treatment group. 2. The finished allograft is between 0.2 to 0.5 mm in thickness and contains both human epidermis and dermis tissues. 2004;64(2):282-286. Treatment of diabetic foot ulcer using matriderm in comparison with a skin graft. Available evidence on CPI has focused mainly on the effects of low-level radiofrequency signals on growth factors and cell proliferation in vitro. Links to various non-Aetna sites are provided for your convenience only. Belcher HJ, Zic R. Adverse effect of porcine collagen interposition after trapeziectomy:A comparative study. The extracellular matrix of the fetal wound: Hyaluronic acid controls lymphocyte adhesion. Waltham, MA: UpToDate; reviewed November 2012. UpToDate [online serial]. Niederauer MQ, Michalek JE, Liu Q, et al. Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction:A prospective comparative study. 24-month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex 1S permanent reinforced tissue matrix. Parker MJ, Kim RC, Barrio M, et al. 1999;25(3):256-261. Giordano P, Sileri P, Buntzen S, et al. Waltham, MA: UpToDate; reviewed January 2021. For questions on reimbursement or to find information for a specific product, please contact the Arthrex Coding and Reimbursement Hotline at 1-844-604-6359 or email us at arthrex@cmcopilot.com. Lavery LA, Killeen AL, Farrar D. The effect of continuous diffusion of oxygen treatment on cytokines, perfusion, bacterial load, and healing in patients with diabetic foot ulcers. 2005;76(11):1814-1822. Revitalon can be used as a covering for full-thickness wounds, damaged membranes, and as a dressing for burns. -peroneal. 2006;10(5):419-425. Lee MS. GraftJacket augmentation of chronic Achilles tendon ruptures. Rouleau G, Erickson LJ. London, UK: BMJ Publishing Group; September 2007. 2022;19(3):470-481. During the healing process, the device is degraded and completely resorbed, leaving new tissue where scar tissue would normally be expected. Ann Coloproctol. Custom sizes and thicknesses are available upon request. Advanced biological therapies for diabetic foot ulcers. Foot Ankle Int. Urology. Suprathel, a new skin substitute, in the management of donor sites of split-thickness skin grafts: Results of a clinical study. and 5/box). 2012;69(4):418-421. Eaglstein WH, Falanga V. Tissue engineering and the development of Apligraf, a human skin equivalent. Ward KC, Costello KP, Baalman S,et al. 2012;130(5 Suppl 2):216S-224S. PDF HCPCS Level II Coding Reference Guide - Zimmer Biomet Baltimore, MD: CMS;May 18, 2011. #: DOC1-001036-en-USVersion: ALanguage: EnglishRevision Date: 03/03/2023 2023 Coding and Reimbursement Guidelines for the BicepsButton Implant and Pec ButtonFile Type: Ref. 2010;76(1):1-6. WoundEx Flow (Skye Biologics) consists of placental connective tissue matrix intended to replace or supplement damaged or inadequate connective tissue (CMS, 2017). VIM human amniotic membrane is a marginally modified allograft sheet of human amnion that is eventually sterilized. At baseline, no statistically significant differences between patients and wounds were observed. Podiatry Today. Obes Surg. Am J Surg. The device was intended to be used continuously; however, there were inevitably times the device came off while the patient was sleeping or during the day, and because all of our study subjects had severe diabetic sensory neuropathy, the problem was often not identified immediately. Nelson EA, Jones J. Venous leg ulcers. 2007;12(2):65-82. 2004;36(3):250-254. Non-adherent versus traditional dressings for wound care: Comparative effectiveness, safety, and guidelines. Package Insert. McCarthy CM, Lee CN, Halvorson EG,et al. Burns. Durmush EK, Ermerak G, Durmush D. Short-term outcomes of sleeve gastrectomy for morbid obesity: Does staple line reinforcement matter? 32-LCT-01. Schwandner T, Roblick MH, Kierer W,et al. Cullum N, Petherick E. Pressure ulcers. Armstrong DG, Orgill DP, Galiano RD, et al. 2019;8(5):e465-e472. Arch Dermatol. Watertight sealing without lumbar drainage for incidental ventral dural defect in transthoracic spine surgery: A retrospective review of 53 cases. 2019;34:397-402. Burn injuries were randomly selected, partly treated with Omiderm (a polyurethane membrane) and partly treated with Suprathel. 2017b;213(6):1046-1052. Chaby G, Senet P, Vaneau M, et al. Repair of abdominalwall defects with bovine pericardium. 2007;58(3):264-267. Arch Surg. 2014;24(7):1109-1116. 2013;133(6):841-851. Dis Colon Rectum. 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. AlloDerm for duraplasty in Chiari malformation: Superior outcomes. 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. Stilwell R, Delaney R. The biomechanics of ProLayer acellular dermal matrix: Biocompatibility study. Balayssac D, Poinas AC, Pereira B, Pezet D. Use of permacol in parietal and general surgery:A bibliographic review. Eur J Obstet Gynecol Reprod Biol. Ratto C, Litta F, Parello A, et al. Ann Plast Surg. Wounds related to dystrophic epidermolysis bullosa. UpToDate [online serial]. Podiatry Today. Additionally, these patients had to have not demonstrated a 50% reduction in would area following 4 weeks of standard treatment for inclusion in this study. Specifically, the device processes a small, thin split-thickness skin sample 0.006-0.008 inch (0.15-0.20 mm) in depth to prepare an autologous Regenerative Epidermal Suspension (RES) for immediate delivery onto the wound surface.