Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). placement of closed suction drainage was only used in 79 patients (group B). Suprathel is also available in hand-shaped pads that can be used on the flexor and/or exterior side of the hand. Arch Facial Plast Surg. 2016;25 Suppl 7:S18-S25. Schardey HM, Di Cerbo F, von Ahnen T,et al. 2015;46(1):43-50. Int Wound J. J Am Coll Surg. Moravvej H, Hormozi AK, Hosseini SN, et al. TruSkin is supplied as a graft in two sizes: 32 cm and 8cm. Schwarze H, Kuntscher M, Uhlig C,et al. Steed DL, Donohoe D, Webster MW, Lindsley L. Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. J Burn Care Res. 2016;32(2):73-78. Dis Colon Rectum. Surg Neurol Int. Clin Biomech (Bristol, Avon). 2003;11(4):248-252. SurgiMend Collagen Matrix (TEI Biosciences, Boston, MA) was cleared through the FDA 510(k) process in 2007. 2012;22(1):42-46. For placement of amniotic membrane using tissue glue . Int Wound J. 2010;100(1):73-77. The authors concluded that ProLayer ADM was designed to offer optimal suture retention and tensile strength while retaining essential flexibility and pliability characteristics allowing for secure placement and suturing. Premarket Approval Application No. Randomized, prospective, blinded-enrollment, head-to-head venous leg ulcer healing trial comparing living, bioengineered skin graft substitute (Apligraf) with living, cryopreserved, human skin allograft (TheraSkin). The stiffness of the autologous group approached significance versus the no-glue group. Burn injuries were randomly selected, partly treated with Omiderm (a polyurethane membrane) and partly treated with Suprathel. 2014;27(11):513-516. 2013;23(4):270-275. Arthroscopy. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2013. 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. 2021;35(9):5173-5178. 2009;65(3):565-575. Leboeuf L, Miles RA, Kim SS, Gousse AE. Surg Endosc. Inguinal hernia repair with porcine small intestine submucosa: 3-year follow-up results of a randomized controlled trial of Lichtenstein's repair with polypropylene mesh versus Surgisis Inguinal Hernia Matrix. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. Clinical and in vitro responses of bilayered skin construct (graftskin) to meshing. Centers for Medicare & Medicaid Services (CMS) Agenda for Health Common Procedures Coding System (HCPCS). A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Mericli AF, Garvey PB, Giordano S, et al. #: OF1-000306-en-USVersion: GLanguage: EnglishRevision Date: 02/23/2023 2023 Coding and Reimbursement Guidelines for the Foot/Ankle Anchors Soft-Tissue ImplantsFile Type: Ref. No. Living cells or collagen matrix: which is more beneficial in the treatment of diabetic foot ulcers? Eppley BL, Pietrzak WS, Blanton M. Platelet-rich plasma: A review of biology and applications in plastic surgery.
SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Podiatry Today. 1993;128(11):1227-1233. J Burn Care Rehabil. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. American Medical Association Technology News. Silver- coated wound dressings such as Acticoat and Actisorb offer new forms of dressing for burn wounds, but require further investigation. This finding was largely driven by ulcers greater than 10 to 80 cm2 in size, as these ulcers had a higher mean percentage of re-epithelialization at 14 weeks (ASCS + compression: 69.97 % and Control: 11.07 %, p = 0.0480). In a prospective study, these researchers examined the clinical performance of ReCell versus meshed split-thickness skin grafts (STSG, Control) for the treatment of deep partial-thickness burns. Final corrected distance visual acuity was better in subjects submitted to AMT. 2012;50(2):165-169. Scand J Plast Reconstr Surg Hand Surg. 2011;15(5):575-578. Accessed July 7, 2009. J Hand Surg Am. Limitations of the study include that it was retrospective and lacked a control group. Hankin CS, Knispel J, Lopes M,et al. Foy AB, Giannini C, Raffel C. Allergic reaction to a bovine dural substitute following spinal cord untethering. Each allograft is restricted to homologous use in procedures on a single occasion by a licensed physician or surgeon. The specimens were divided into 5 groups. Bergstrom N, Bennett MA, Carlson CE, et al. Burns. Int Urogynecol J Pelvic Floor Dysfunct. Hand (N Y). J Neurosurg. Public Meeting Summary Report. Dural repair with four spinal sealants: Focused review of the manufacturers' inserts and the current literature. Kolker AR, Brown DJ, Redstone JS, et al. Healthcare Common Procedure Coding System (HCPCS). Repliform is an acellular human dermis for pelvic floor repair. Biobrane versus duoderm for the treatment of intermediate thickness burns in children: A prospective, randomized trial. TEC Assessment Program. In a retrospective study, these researchers examined the safety and effectiveness of a biologically active cryo-preserved human skin allograft for treating wounds with exposed bone and/or tendon in the lower extremities. 2008;181(3):2103-10. An evidence review prepared for the Cochrane Collaboration (Bergin et a., 2006) concluded: "Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy:A single-blinded, randomized controlled trial. Clinical and economic outcomes with graftskin for hard-to-heal venous leg ulcers:A single-center experience. Byrnes MC, Irwin E, Carlson D,et al. There are several products that provide intermittent topical oxygen therapy, usually once-daily. Stravix is processed from human umbilical cord and contains a collagen/hyaluronic acid (HA)-rich extracellular matrix; endogenous bio-factors with anti-inflammatory, angiogenic, anti-scarring, and anti-microbial properties; as well as viable endogenous cells, including mesenchymal stem cells (MSCs). Although it is less cost-effective than Omiderm, the significant increase of patient comfort makes this material represent a reliable and solid treatment alternative when dealing with partial-thickness burn injuries. The proprietary processing of VIM human amniotic membrane allograft results in the preservation of structural and signaling proteins such as collagen, glycoproteins, proteoglycans, cytokines, and growth factors, that are important to biochemical and biomechanical processes occurring at a cellular level. Eaglstein WH. Orthopedics. Steenfos HH. ); For ear drum augmentation (tympanoplasty), repair of skull base defect, and temporal bone lining. Superior capsule reconstruction for irreparable rotator cuff tears: A systematic review of biomechanical and clinical outcomes by graft type. Patients were advised not to use any compression system during the study. It protects the wound bed to aid in the development of granulation tissue and provides a human biocompatible extracellular matrix that retains 250+ regulatory proteins. Comparision of clinical and histopathological results of hyalomatrix usage in adult patients. Buchberg B, Masoomi H, Choi J,et al. (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). World J Surg Oncol. J Neurosurg. Am J Surg. London, UK: NICE; January 2018. 2009;36(3):179-181. J Cardiothorac Surg. Zenith Amniotic Membrane is a dehydrated amniotic membrane allograft. Single-institution outcome experience using AlloDerm as temporary coverage or definitive reconstruction for cutaneous and soft tissue malignancy defects. The product is applied directly on or in the wound with a 20-23 gauge needle. 2012;21(10):476, 478-80, 482. Treatment of a persistent iatrogenic cerebrospinal fluid-pleural fistula with a cadaveric dural-pleural graft. Asmis R, Qiao M, Zhao Q. Low-flow oxygenation of full-excisional skin wounds on diabetic mice improves wound healing by accelerating wound closure and reepithelialization. Choi YM, Campbell K, Levek C, et al. Cochrane DatabaseSyst Rev. September 27, 2018. Comparison of AlloDerm and AlloMax tissue incorporation in rats. AGENDA ITEM #1 1 . Culligan PJ, Littman PM, Salamon CG,et al. In vitro assessment of a novel, hypothermically stored amniotic membrane for use in a chronic wound environment. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. J Oral Maxillofac Surg. 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. Language services can be provided by calling the number on your member ID card. Successful treatment of a patient with an extraordinarily large deep burn. one of the skin application procedures described by HCPCS code C5271-C5278. Evaluation of bioabsorbable seamguard for staple line reinforcement in stapled rectal anastomoses. 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. Musculoskelet Surg. More specifically, the amniotic membrane provides a vapor barrier preventing undesirable water loss from excessive evaporation at the wound with a resultant decrease in pain and inflammation. 2014;11(5):554-560. J Shoulder Elbow Surg. A moist wound healing environment allows autolytic dbridement. Int Braz J Urol. J Oral Maxillofac Surg. 2003;29(8):863-866. 1997;18(1 Pt 1):52-57. ClinicalTrials.gov. 2013;39(5):876-880. 2014;11(5):472-475. Fajardo AD, Amador-Ortiz C, Chun J,et al. 2010;20(4):462-467. de la Portilla F, Rada R, Vega J,et al. In an open-label study, subjects were randomized to receive an application of non-cultured autologous skin cells ("spray-on" skin; ReCell) or SOC interventions for large (greater than 6 cm2), adequately vascularized wounds. Wound Repair Regen. Case report. Early experience treating tricuspid valve endocarditis with a novel extracellular matrix cylinder reconstruction. Foot Ankle Spec. 2011;156(2):223-227. Zerris VA, James KS, Roberts JB, et al. 2014;77(3 Suppl 2):S204-S207. -sural. StrataGraft is indicated for topical application by a healthcare provider for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). Palfreyman SJ, Nelson EA, Lochiel R, Michaels JA. Marx RE. Cazzell S. A randomized controlled trial comparing a human acellular dermal matrix versus conventional care for the treatment of venous leg ulcers. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. There is a lack of evidence in the peer-reviewed medical literature to support it's clinical effectiveness. SurgiMend. Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction:A prospective comparative study. Stilwell R, Delaney R. The biomechanics of ProLayer acellular dermal matrix: Suture retention strength. Sultan AA, Samuel LT, Roth A, et al. Baltimore, MD: CMS January 1, 2022. Koutsougeras G, Nicolaou P, Karamanidis D,et al. Ther Umsch. Suprathel, a new skin substitute, in the management of partial-thickness burn wounds: Results of a clinical study. Quiroz LH, Gutman RE, Shippey S,et al. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: A prospective controlled study. The product is applied topically by placing the membrane over the wound or within the surgical site. Thon SG, O'Malley L, 2nd, O'Brien MJ, Savoie FH, 3rd. The combination of polytetrafluoroethylene mesh and titanium rib implants: An innovative process for reconstructing large full thickness chest wall defects. Ann Plast Surg. 2005;52(6):1104. 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. Successful grafting with EpiDex in pyoderma gangrenosum. 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. Phillips LG, Robson MC, Smith DJ, et al. 2000;26(7):609-619. A retrospective clinical review of extracellular matrices for tissue reconstruction: Equine pericardium as a biological covering to assist with wound closure. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Arch Bone Jt Surg. The quantity of product used varies based upon surgical application, individual patient circumstances, and the dimensions of the surgical site. The use of Strattice porcine-derived decellularized collagen products has been proposed for use in various surgical procedures and in the treatment of dermal wounds. Zidan et al performed a single center prospective randomized controlled trial in Egypt consisting of 40 patients with thermal burns or trauma undergoing STSG. In: BMJ Clinical Evidence. Am J Surg. 2015;12(5):545-547. 2018;34(1):93-99. Balayssac D, Poinas AC, Pereira B, Pezet D. Use of permacol in parietal and general surgery:A bibliographic review. Harth KC, Rosen MJ. Public Meeting for Code Applications for Non-Drug and Non-Biological Items and Services Submitted to CMS 2nd 2021 Biannual HCPCS Coding Cycle. Peer-reviewed literature is limited to a small short-term randomized controlled pilot study which found that the Provant system accelerated closure of pressure wounds (Ritz et al, 2002). There were no statistically significant differences in the distribution of CCI, age, sex, and region among cohorts. Cervigni M, Natale F, La Penna C, et al. The analysis tool computes local and global statistics for various cell measurements over the time sequence. Plast Reconstr Surg. Tissues biopsies were obtained at each visit to assess cytokines and quantitative bacterial cultures. Am Surg. Synovis Surgical Innovations. Experience with the use of apligraf to heal complicated surgical and nonsurgical wounds in a private practice setting. -load sharing device. J Shoulder Elbow Surg. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft for the treatment of venous leg ulcers. Puros Dermis Allograft Tissue Matrix (Zimmer Dental) is a natural biological matrix designed for soft tissue augmentation, periodontal/peri-implant soft tissue management, and guided tissue regeneration procedures (Snyder et al, 2012). 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). 1999;20(3):195-200. Insufficient information was provided regarding randomization in this study. Int Wound J. Burns. Burns. Postoperative management of incidental durotomy in minimally invasive lumbar spinal surgery. The authors found that allwounds in this study that were treated with Suprathel healed without grafting. Giza E, Frizzell L, Farac R,et al. Apligraft has been approved for marketing under a premarket approval for "use with standard therapeutic compression for the treatment of noninfected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy." The finished allograft is between 0.2 to 0.5 mm in thickness and contains both human epidermis and dermis tissues.