Mol Med Report. Acta Dermatovenerol Alp Panonica Adriat. 2017;43(4):804-811. 2014;29(9):1125-1130. Simon TE, Scott JA, Brockmeyer JR, et al. Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction:A prospective comparative study. Procuren: A platelet-derived wound healing formula. 2013;287(6):1205-1209. Biologic mesh use practice patterns in abdominal wall reconstruction:A lack of consensus among surgeons. 2022;75:103446. Health Technol Assess. Afaneh C, Abelson J, Schattner M,et al. 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. 2013;30(3):xiii-xiv. Santiago GF, Bograd B, Basile PL, et al. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft for the treatment of venous leg ulcers. Case presentation: Xenograft resistance to protease degradation in a vasculitic ulcer. No effect of fibrin sealant on drain output or functional recovery following simultaneous bilateral total knee arthroplasty:A randomized, double-blind, placebo-controlled study. Wounds. Achilles tendon repair with acellular tissue graft augmentation in neglected ruptures. It is supplied in sizes: 2cm x 2cm, 4cm x 4cm, 6cm x 6cm 10cm x 10cm; and 12cm x 12cm. Muscle Nerve. J Neurosurg. Koike T, Yasuo M, Shimane T, et al. Eur J Cardiothorac Surg. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Soft tissue injury management with a continuous external tissue expander. J Burn Care Res. A prospective, randomized trial of Acticoat versus silver sulfadiazine in the treatment of partial-thickness burns: which method is less painful? Gravante G, Sorge R, Merone A,et al. 2009;9(8):623-629. Website: www.ventrismedical.com Email: info@ventrismedical.com Phone: (949) 706-5551 Fax: (949) 706-5552 BJOG. SurGraft TL is available in a single use package in various sizes. Edmonds ME, Foster AV, McColgan M. 'Dermagraft': A new treatment for diabetic foot ulcers. The use of veritas collagen matrix to reconstruct the posterior chest wall after costovertebrectomy. 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. London, UK: NICE; November 2011. 2008;122(4):1206-1213. Language services can be provided by calling the number on your member ID card. Links to various non-Aetna sites are provided for your convenience only. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. These injuries can result in inflammation, reduced mobility, and chronic pain. 2011;13(1):94-104. Barbul A, Gurtner GC, Gordon H, et al. The rate of infection was 3.8% (8/229). Int Wound J. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Supra SDRM is fully malleable at room temperature and becomes more pliable at body temperature and can be conformed three dimensionally to multiple anatomical orientations. 1996;53(4):304-308. Helton WS, Fisichella PM, Berger R,et al. 2013;17(2):187-191. 2010;76(1):96-100. July 13, 2011. Treatment of diabetic foot ulcer using matriderm in comparison with a skin graft. Int Wound J. The product is supplied as 2.56 cm x 2.56 cm and 10 cm x 13 cm sizes and packaged in a primary foil pouch and secondary Tyvek pouch and sterilized by e-beam. Reinforced biologic mesh reduces postoperative complications compared to biologic mesh after ventral hernia repair. 2013;34(23):5776-5784. 2013;56(6):774-779. Zelen CM. 2012;21(12):1746-1752. 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. WoundEx membrane is intended to be used as a wound covering in the treatment of chronic and acute wounds. Use of Integra artificial skin is associated with decreased length of stay for severely injured adult burn survivors. Insufficient information was provided regarding randomization in this study. 2020;36 Suppl 1:e3284. Posterior repair with perforated porcine dermal graft. 2016;28(4):119-125. At week 12, seven (63.6%) patients in the HSA and four (33.3%) in the HFDS group were healed (P = 0.0498). Inan I, Gervaz P, Hagen M, Morel P. Multimedia article. Br J Dermatol. 2012;37(8):1538-1542. Pugliese R, Maggioni D, Sansonna F,et al. Robinson PM, Muir LT. Foreign body reaction associated with Artelon: Report of three cases. The product does not stay permanently engrafted, but undergoes replacement by the patients own cells over time. 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). Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Wounds. Studies published between January 1, 2000 and June 1, 2018 were reviewed. J Biomed Mater Res B Appl Biomater. Micronized, particulate dermal matrix to manage a non-healing pressure ulcer with undermined wound edges: A case report. Ultimate tensile failure loads of a human dermal allograft rotator cuff augmentation. Center for Medicare and Medicaid Services (CMS). Adams JE, Merten SM, Steinmann SP. Przegl Lek. Adv Skin Wound Care. RECELL Autologous Cell Harvesting Device. BMC Bioinformatics. 2012;19(3):288-294. 2001;2(5):305-313. 2011;127(3):1047-1058. Collagen-based wound care products: Summary of INAHTA reviews. Postoperative cervical cord compression induced by hydrogel dural sealant (DuraSeal). 2009;144(10):894-899. Kruper GJ, Vandegriend ZP, Lin HS, Zuliani GF. Long EL, Rebibo JD, Caremel R, Grise P. Efficacy of Pelvisoft Biomesh for cystocele repair: Assessment of long-term results. Baltimore, MD: CMS; December 2, 2021c. Farole A, Jamal BT. Ann Plast Surg. 2004;17(5):207-13. DeNoto G, 3rd. Long-term outcomes (>5-year follow-up) with porcine acellular dermal matrix (Permacol) in incisional hernias at risk for infection. J Am Coll Surg. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Mil Med. Histologic analysis of fetal bovine derived acellular dermal matrix in tissue expander breast reconstruction. Burns. J Clin Aesthet Dermatol. Biomechanical, biochemical, and cellular properties. The cost of treatment per square centimeter for Mepilex Ag was considerably lower than that of Suprathel. 2014;41(4):337-343. Supra SDRM is composed of a tripolymer of polylactide, trimethylene carbonate, E-caprolactone and polyvinyl alcohol. 2012;28(1):8-15. Zelen CM, Serena TE, Fetterolf DE. Burns. Advantage of the presence of living dermal fibroblasts within in vitro reconstructed skin for grafting in humans. Surg Endosc. Int Wound J. 2006;57(1):1-5. Cheng AW, Abbas MA, Tejirian T. Outcome of abdominal wall hernia repair with biologic mesh: Permacol versus Strattice. The authors concluded that skin substitute usage in MMS reconstruction is not well-guided. Nelson EA, Jones J. Venous leg ulcers. Skin substitutes for treating chronic wounds. surgiGraft serves to act as a tissue barrier/covering or to provide lubrication. These researchers stated that blinded randomized control trials (RCTs) comparing the effectiveness of skin substitutes and traditional repair methods are imperative for establishing evidence-based guidelines on skin substitute usage following MMS. In addition to this study, additional weak . Ditzel M, Deerenberg EB, Grotenhuis N, et al. 2015;41:177-188. Rockville, MD: AHRQ; December 18, 2012. Exp Eye Res. Otto S, Kleye C, Burian E, et al. Adelaide, SA: Royal Australasian College of Surgeons, Australian Safety and Efficacy Registry of New Interventional Procedures - Surgical (ASERNIP-S); updated February 2007. Accessed March 4, 2005. Min JH, Yun IS, Lew DH, et al. Foot Ankle Spec. Preminger BA, McCarthy CM, Hu QY,et al. Premium Product. 2013;133(6):841-851. Signature APatch can be used in combination with tissue adhesives or semi-wet dressings for allograft application if necessary. Accessed December 26, 2012. The development of bioengineered skin. Silver Spring, MD: FDA; September 21, 2018. Arch Orthop Trauma Surg. Plast Reconstr Surg. 2007;18(11):1337-1341. In: BMJ Clinical Evidence. J Otolaryngol Head Neck Surg. U.S. Food and Drug Administration (FDA). Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Petri M, Greenspoon JA, Millett PJ. Clin Plast Surg. Ann Thorac Surg. The healing rate with the graft was better than SOC across multiple subsets, but the most significant improvement was noted in the worst wounds that had a duration of 90 to 179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner grade-4 ulcers (p = 0.04). Preliminary results of arthroscopic superior capsule reconstruction with dermal allograft. Walters J, Cazzell S, Pham H, et al. InnovaMatrix AC [website]. However, these researchers stated that currently there is no evidence to support the routine use of sprayon skin to achieve these goals for this subset of patients. Cochrane DatabaseSyst Rev. Clinically relevant mechanical testing of hernia graft constructs. 2007;33(8):946-957. Dermatology. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS). Patients treated with CHSA received fewer product applications than DSS at 90 and 180 days (p < 0.05). 2011;8(2):177-183. Br J Plast Surg. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Hand (N Y). (2022) reported on a randomized, prospective study comparing the response of 100 subjects with non-healing DFUs of which 50 were treated with TheraSkin compared with 50 subjects treated with standard of care (SOC, collagen alginate dressing) at 12 weeks. 1994;7(5):8-10. According to the manufacturer, the products of Suprathel degradation stimulate the healing process by increasing angiogenesis and rebuilding the dermis. Cerebrospinal fluid leakage from tegmen tympani defects repaired via the middle cranial fossa approach. Int J Oral Maxillofac Surg. Accessed on February 11, 2010. Dell JR, O'Kelley KR. 2018;15(6):950-957. Soft tissue augmentation. 1998;2(2):203-210. Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: Brigido SA, Boc SF, Lopez RC. Public Meeting for Code Applications for Non-Drug and Non-Biological Items and Services Submitted to CMS 1st 2021 Biannual HCPCS Coding Cycle. Centers for Medicare & Medicaid Services (CMS). 2006;22(5):534-538. Ann Plast Surg. AmnioRepair is indicated for use as a biological barrier or wound cover. Repair of high-risk incisional hernias and traumatic abdominal wall defects with porcine mesh. Pol Przegl Chir. These researchers noted that although the cohorts were matched for CCI, a limitation of claims analysis in wound care studies is that there is no reliable and consistent way to measure wound severity. Diabetic foot problems: Inpatient management of diabetic foot problems (Draft). 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. Tong E, Martin F, Shelley O. 2011;4(1):29-41. Torabi R, Strong AL, Hogan ME, et al. Greer N, Foman NA, MacDonald R, et al. Complications of alloderm and dermamatrix for parotidectomy reconstruction. Use of regenerative human acellular tissue (AlloDerm) to reconstruct the abdominal wall following pedicle TRAM flap breast reconstruction surgery. Bond JL, Dopirak RM, Higgins J,et al. 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. 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. A draftassessment of wound care products prepared for AHRQ (2019)judged this randomized controlled study by Towler et al (2018) to be atmoderate risk of bias. Comparison study of acellular dermal matrices in complicated hernia surgery. Mulder G, Lee DK. Chen J, Lee S, Lui T,et al. CETS 2000-5 RE. Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: An interim analysis. 2009;6(3):196-208. Functional properties of a purified reconstituted bilayer matrix design support natural wound healing activities. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: A prospective controlled study. Harvey RJ, Nogueira JF, Schlosser RJ, et al. 2014(4):1-4. 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. Epidermal stem cells are preserved during commercial-scale manufacture of a bilayered, living cellular construct (Apligraf). Cambridge, MA: Genzyme; 2010. Use of cryopreserved, particulate human amniotic membrane and umbilical cord (AM/UC) tissue: A case series study for application in the healing of chronic wounds. surgical technique consisting of debridement and marrow stimulation with application of micronized allograft cartilage matrix (BioCartilage , Arthrex, Naples, FL). Wien Med Wochenschr. Hansbrough JF, Mozingo DW, Kealey GP,et al. Bridged repair of large ventral hernia defects using an ovine reinforced biologic: A case series. Supra SDRM (PolyMedics Innovations Inc.) is a novel, resorbable synthetic skin substitute, guided wound closure matrix, built as a bimodal foam membrane structure for the management of epidermal and dermal wounds, including those caused by burns, pressure ulcers, and venous ulcers, among other wounds. U.S. Food and Drug Administration (FDA). Tissue Eng Part A. 1998;176(2A Suppl):80S-82S. Wound Repair Regen. 2019;32(1):26-36. 59. Pro3-Placenta is single-layer amnion that is ideal for dermatological application such as topical wounds and burns. Aycock J, Fichera A, Colwell JC, Song DH. Kimmel HM, A comparison of continuous oxygen therapy to topical oxygen. Talymed is placed on the open wound and covered with a transparent dressing. Burns. Patel KM, Bhanot P. Complications of acellular dermal matrices in abdominal wall reconstruction. The vial is packaged in a foil pouch and then terminally sterilized using e-beam irradiation. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers:A prospective, randomised, multicentre study. Sari E, Eryilmaz T, Tetik G, et al. Ann Plast 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. BJOG. The authors concluded that the ReCell system was a feasible, simple and safe technique. Ann Plast Surg. Baltimore, MD: CMS;May 18, 2011. Obes Surg. Bullard D, Souza J. Three-level anterior cervical discectomy and fusion with plate fixation: Radiographic results of 127 patients. Lee G, Lee CK, Bynevelt M. DuraSeal-hematoma: Concealed hematoma causing spinal cord compression. Lullove E. Acellular fetal bovine dermal matrix in the treatment of nonhealing wounds in patients with complex comorbidities. Mdry R, Struyna J, Stachura-Kuach A,et al. Utilization of a new tissue expander in the closure of a large Mohs surgical defect. 2007;106(1):45-51. Johnson W, Inamasu J, Yantzer B,et al. #: 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. Adv Skin Wound Care. Organogenesis. Carlson M, Faria K, Shamis Y,et al. Clin Neuropathol. Themanufacturer also stated that "SurGraft is minimally manipulated Human Cell Tissue Product (HCT/P) intended for homologous use."
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