It provides a support structure for cellular migration and as such the matrix is incorporated into the surrounding tissue. 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. J Burn Care Res. The prescribed dosage varies by the size of the wound. In: BMJClinical Evidence. This product is highly porous and allows for cellular infiltration and vascularization before completely degrading via hydrolysis into the wound bed. 2008;63(1 Suppl 1):ONS182-ONS186; discussion ONS186-ONS187. Talymed (Marine Polymer Technlogies,Inc., Danvers, MA)is a sterile advanced wound matrix comprised of shortened fibers of poly-N-acetylglucosamine, isolated from microalgae (Snyder, et al., 2012). Dural repair with four spinal sealants: Focused review of the manufacturers' inserts and the current literature. Arthrex Amnion matrix is rich in growth factors and contains regenerative qualities that maintain the natural healing properties of amnion. In a National Institute for Health and Care Excellence (NICE) medical technology guidance, Peirce and Carolan-Rees stated that the gold standard treatment for deep burns is an autologous skin graft; in larger burns this may be meshed to increase the area covered. 2019;38(1):45-59. Spine (Phila Pa 1976). U.S. Food and Drug Administration (FDA). 2008;70(1):92-96; discussion 96-97. Four groups received augmentation of the repair with application of either autologous fibrin glue, Tisseel fibrin glue, Evicel fibrin glue, or DuraSeal polyethylene glycol-based hydrogel sealant, and the 5th group had no glue. Diaz JJ Jr, Guy J, Berkes MB, et al. Saray A. Porcine dermal collagen (Permacol) for facial contour augmentation: Preliminary report. Baltimore, MD: CMS; August 2, 2012. Baltimore, MD: CMS; June 9, 2022. J Pediatr Surg. A prospective comparison of diabetic foot ulcers treated with either cryopreserved skin allograft or bioengineered skin substitute. Outcomes analysis of biologic mesh use for abdominal wall reconstruction in clean-contaminated and contaminated ventral hernia repair. 2012;99(10):1381-1388. Public Meeting Summary Report. The authors concluded that this study provided evidence that the treatment of deep partial-thickness burns with ASCS resulted in comparable healing, with significantly reduced donor site size and pain and improved appearance relative to STSG. 2003;14(1):17-23; discussion 21-22. Venous leg ulcers. 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. 59. 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. Puros Dermis does not have 510(k) clearance or premarket approval, suggesting that this is a human-derived tissue product. Available at: http://www.fda.gov/cdrh/pdf7/K072113.pdf. Eur J Cardiothorac Surg. 2004;52(2):188-194. Wound Repair Regen. Waltham, MA: UpToDate; reviewed January 2021. Acta Biomater. K050355. Prevention and management of foot problems in people with diabetes. Eur J Plast Surg. 1997;18(2):147-155. Public Meeting for Code Applications for Non-Drug and Non-Biological Items and Services Submitted to CMS 1st 2021 Biannual HCPCS Coding Cycle. This short-term pilot study showed that injectable, flowable amniotic allografts can be used for orthopedic sports injuries of the lower extremities. Ann Plastic Surg. Baltimore, MD: CMS;May 25, 2011. Donated human tissue. Derwin KA, Baker AR, Spragg RK, et al.Commercial extracellular matrix scaffolds for rotator cuff tendon repair. The stiffness of the autologous group approached significance versus the no-glue group. A morphological and biochemical analysis comparative study of the collagen products Biopad, Promogram, Puracol, and Colactive. 2012;39(2):167-175. Stockholm, Sweden: SBU; 2003. Teflon felt adhesion and the sling retraction technique. Recurrent abdominal laxity following interpositional human acellular dermal matrix. J Hand Surg Am. It is applied over a wound or burn site following wound preparation in multiple sites of care. Leboeuf L, Miles RA, Kim SS, Gousse AE. Dermatol Surg. Semin Pediatr Surg. Weinstein JS, Liu KC, Delashaw JB Jr,et al,The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials. Use the current applicable CPT/HCPCS code(s). Am Surg. Farr J, Gomoll AH, Yanke AB, et al; ASA Study Group. Mepitel Ag (hazard ratio [HR] 0.57 (95 % confidence interval [CI]: 0.40 to 0.82); p = 0.002) significantly reduced the rate of wound healing, adjusting for burn thickness and fungal wound infection. 2018;7:3, Pennington WT, Bartz BA, Pauli JM, et al. Alfieri A, Schettino R, Taborelli A,et al. XCellerate is provided in a sterile sealed package and is intended for single use. Narotam PK, Qiao F, Nathoo N. Collagen matrix duraplasty for posterior fossa surgery: Evaluation of surgical technique in 52 adult patients. As a new category of products . Int Wound J. Bowering K, Embil JM. Barber FA, Herbert MA, et al.Tendon augmentation grafts: biomechanical failure loads and failure patterns. Superior capsular reconstruction: Clinical outcomes after minimum 2-year follow-up. 1996;19(4):350-354. Urrea-Botero G. Can continuous diffusion of oxygen heal chronic toe ulcers? 2018;38(6):554-562. "WoundEx Thin Membrane is designed as a single layer wound covering for common wounds, and WoundEx Thick Membrane is designed as a thicker single layer wound covering, for deeper wounds where more tissue bulk is required." TheraSkin is generally applied like an autograft, insuring that the dressing is in close contact with the wound surface and that shear is minimized. Amani H, Dougherty WR, Blome-Eberwein S. Use of Transcyte((R)) and dermabrasion to treat burns reduces length of stay in burns of all size and etiology. Skin substitutes for the management of mohs micrographic surgery wounds: A systematic review. This protective dressing should comprise a fatty gauze and absorbent gauze. DiDomenico LA, Orgill DP, Galiano RD, et al. Wounds. 2011;(7):CD003091. Rockville, MD: FDA; October 10, 2007. Min JH, Yun IS, Lew DH, et al. Dermagraft, a bioengineered human dermal equivalent for the treatment of chronic nonhealing diabetic foot ulcer. Postoperative cervical cord compression induced by hydrogel (DuraSeal):A possible complication. Eplasty. In conclusion, adding TheraSkin to SOC appeared to significantly improve wound healing with a lower incidence of adverse events related to treatment compared with SOC alone. 2006;(2):CD002930. The use of human amnion/chorion membrane in the clinical setting for lower extremity repair:A review. Soluble Systems, TheraSkin. The authors reported that SurgiMend demonstrated a very infrequent inflammatory response. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Diabetic foot problems: Prevention and management. Gravante G, Sorge R, Merone A,et al. TenoGlide tendon protector sheet (Tendon Wrap tendon protector, Integra LifeSciences Corp., Plainsboro, NJ) was cleared through the FDA 510(k) process in 2006. 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." Systematic review of the efficacy and safety of using mesh or grafts in surgery for uterine or vaginal vault prolapse. Frykberg RG, Cazzell SM, Arroyo-Rivera J, et al. 2012;130(5 Suppl 2):35S-43S. Colorectal Dis. Huang H, Kitano K, Nagayama K,et al. Horizon Scanning Prioritising Summary. The use of autologous platelet gel to treat difficult-to-heal wounds: A pilot study. They searched MEDLINE, CINAHL, and the Cochrane Controlled Trials Registry Database to identify RCTs. Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. 2013;71(3):297. J Plast Reconstr Aesthet Surg. Another consideration was the application regimen used by the clinicians treating with BSA. Injectable skin fillers. Adv Orthopedic Surg. Aesthet Surg J. The extracellular matrix of the fetal wound: Hyaluronic acid controls lymphocyte adhesion. Wounds 2017;29(7):E51-E54. Acta Orthop Traumatol Turc. J Wound Care. Cochrane Database Syst Rev. 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. According to the manufacturer, Surgenex, LLC., SurGraft is a dehydrated human amniotic membrane allograft"intended for the treatment of non-healing wounds and burn injuries" (CMS, 2019). Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. 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. Am Surg. 1998;176(2A Suppl):80S-82S. J Wound Care. Reconstruction of intraoral oncologic surgical defects with Integra bilayer wound matrix. Wound care with antibacterial honey (Medihoney) in pediatric hematology-oncology. Vitale MA, Taylor F, Ross M, Moran SL. Until comparative studies of this product have been made available, a thorough evaluation of its safety and effectiveness can not be completed. The evidence for the use of growth factors and active skin substitutes for the treatment of non-infected diabetic foot ulcers (DFU):A health technology assessment (HTA). Heydari A, Attina GM, Merolla E, et al. Commentary. Jansen DA, Asgari MM, Atillasoy ES, Milstone LM. Cultured epithelial autografts in extensive burn coverage of severely traumatized patients: A five year single-center experience with 30 patients. Pennington WT, Chen SW, Bartz BA, Pennington JM. 2019;47(8):1901-1908. van der Meijden OA, Wijdicks CA, Gaskill TR, et al. 2013;100(11):1498-1504. Int J Burns Trauma. 2007;143(10):1297-1304. 2005;76(11):1814-1822. Comparison of AlloDerm and AlloMax tissue incorporation in rats. Long-term outcomes (>5-year follow-up) with porcine acellular dermal matrix (Permacol) in incisional hernias at risk for infection. Harries RL, Luhmann A, Harris DA,et al. Attachment# 16.055 . #: OF1-000119-en-US Version: K Throughout the treatment period, the average pain level was 1.9 on a 10-point scale. Synovis Surgical Innovations. K072113. Arthrosc Tech. Foy AB, Giannini C, Raffel C. Allergic reaction to a bovine dural substitute following spinal cord untethering. 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. Unite Biomatrix (Synovis Orthopedic and Woundcare, Inc.)is a wound biomodulating decellularized extracellular matrix (ECM) that is sourced from equine pericardium (Snyder, et al., 2012). 2011;36(23):1906-1912. The clinical effectiveness in wound healing with extracellular matrix derived from porcine urinary bladder matrix:A case series on severe chronic wounds. DiDomenico L,Emch KJ, Landsman AR. Regulski M, Jacobstein DA, Petranto RD,et al. Both the thin and thick membranes are supplied in the following sizes: 1 x1 cm; 2 X 2 cm; 2 X 4 cm; 4 X 4 cm 4 X 6 cm and 4 X 8 Cm. Identifier NCT00639106. Lullove (2015) noted that damaged connective tissue commonly leads to lower extremity injuries. The HAM group was associated with less pruritis, dressing changes, and discomfort than the non-HAM group. 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. It is derived from porcine dermis and undergoes non-damaging proprietary processing that removes cells and significantly reduces the key component believed to play a major role in the xenogeneic rejection response. Chicago, IL: BCBSA; November 2001;16(12). Secondary safety and effectiveness outcomes were similar between the treatments. Cygnus Matrix is a multilayer allograft derived from the amnion and chorion layers of the Surgery. 2013;(4):CD010182. Patel KM, Bhanot P. Complications of acellular dermal matrices in abdominal wall reconstruction. Auzin M, Teune TM, Hogewoning CJ. Ann Pharmacother. The authors concluded that the findings of this study suggested that TheraSkin may provide equivalent or superior outcomes to Apligraf while reducing costs. Hviid U, Hviid TV, Rudnicki M. Porcine skin collagen implants for anterior vaginal wall prolapse:A randomised prospective controlled study. Sanders et al (2014) reported on a prospective, multicenter, randomized, controlled clinical trial to compare Dermagraft, an in vitro-engineered, human fibroblast-derived dermal skin (HFDS) substitute, and Theraskin, a biologically active cryopreserved human skin allograft (HSA), to determine the relative number of diabetic foot ulcers (DFUs) healed (100% epithelialization without any drainage) and the number of grafts required by week 12. Dis Colon Rectum. Ann Thorac Surg. 2008;61(5):494-499. Beitzel K, McCarthy MB, Cote MP,et al. A retrospective clinical study of 214 consecutive patients to examine the effectiveness of a biologically active cryopreserved human skin allograft (Theraskin) on the treatment of diabetic foot ulcers and venous leg ulcers. Clinical Practice Guideline No. J Med Econ. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Khan ZA, Nambiar A, Morley R, et al. 2004;64(2):282-286. EpiFix is a human amniotic membrane allograft which is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. ArthroCell is a moldable viable cellular allogeneic bone matrix derived from bovine bone marrow. Dis Colon Rectum. J Manag Care Pharm. Currently, there is insufficient evidence to allow for proper evaluation regarding the effectiveness of this technology. Silver dressings for the treatment of patients with infected wounds:A review of clinical and cost-effectiveness. Human split-thickness skin allograft from brain-dead donors. Therefore, we request a new HCPCS code category code: Q4XXX "InnovaMatrix AC, per sq. Podiatr Manag. HCPCS Codes Product HCPCS Codes Layer Matrix duration for which standard wound therapy has failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of 0.70 Int Wound J. 2012;130(5 Suppl 2):27S-34S. Br J Dermatol. Isaacs et al (2008) compared a variety of potentially useful artificial and biological sealants applied to sutured nerve repairs to decrease gapping at the repaired site. Adelmeijer J, Porte RJ, Lisman T. In vitro effects of proteases in human pancreatic juice on stability of liquid and carrier-bound fibrin sealants. 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. Torabi R, Strong AL, Hogan ME, et al. 2015;24(6):261-262, 264-267. J Diabetes Science Tech. 2004;13(4):301-309. Mazzucco L, Medici D, Serra M, et al. According to the manufacturer Orsis Therapeutics Inc., TruSkin is a split-thickness cryopreserved human skin allograft, intended for the replacement or reconstruction of inadequate or damaged integumental tissue. Review Body Report. A modified approach to component separation using biologic graft as a load-sharing onlay reinforcement for the repair of complex ventral hernia. After standard wound preparation, SurGraft TL is placed directly to the wound and adheres to the wound bed without fixation. -load sharing device. 2008;47(1):8-12. Stepney, Australia: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S); August 2006. 2018;39(5):694-702. In this study 14/15 (93.3 %) of the wounds healed completely. Karlsson M, Lindgren M, Jarnhed-Andersson I, Tarpila E. Dressing the split-thickness skin graft donor site:A randomized clinical trial. Massee M, Chinn K, Lei J, et al. Filgate R, Thomas A, Ballal M. Treatment of foregut fistula with biologic plugs. Long EL, Rebibo JD, Caremel R, Grise P. Efficacy of Pelvisoft Biomesh for cystocele repair: Assessment of long-term results. U.S. Food and Drug Administration. Centers for Medicare & Medicaid Services (CMS). Inan I, Gervaz P, Hagen M, Morel P. Multimedia article. Holmes JH, 4th, Molnar JA, Shupp JW, et al. Operative management of anorectal fistulas. Romanelli M, Dini V, Vowden P, Agren MS. Amelogenin, an extracellular matrix protein, in the treatment of venous leg ulcers and other hard-to-heal wounds: Experimental and clinical evidence. A retrospective crossover study of the use of aseptically processed placental membrane in the treatment of chronic diabetic foot ulcers. Plast Reconstr Surg. Int Wound J. Talymed is indicated 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, traumatic wounds healing by secondary intention, chronic vascular ulcers and dehisced surgical wounds and bleeding surface wounds, abrasions and lacerations. Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. Evaluation of host tissue integration, revascularization, and cellular infiltration within various dermal substrates. Pain and assessments of scarring at the treatment sites were reported to be similar between groups. Schlesinger T, Rowland Powell C. Efficacy and safety of a low molecular weight hyaluronic Acid topical gel in the treatment of facial seborrheic dermatitis final report. Armstrong DG, Meyr AJ. Hernia. Ibrahim AM, Rabie AN, Kim PS, et al. J Neurosurg. 2013;2(4):e447-e451. Thekkinkattil DK, Botterill I, Ambrose NS,et al. This device is intended to achieve epidermal regeneration and definitive wound with reduction in skin donor use. The Apligraf Burn Study Group. Singh et al conducted a single center prospective randomized clinical trial in India consisting of 30 patients with ulcers undergoing STSG. Amniotic epithelial stem cells: Salient features and possible therapeutic role. A comparative histologic study. Jiang WG, Harding KG. Int J Oral Maxillofac Implants. 2015;12(6):724-732. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Waltham, MA: UpToDate;reviewed November 2013. Otto S, Kleye C, Burian E, et al. Pro3-Placenta is single-layer amnion that is ideal for dermatological application such as topical wounds and burns. There are few published reports of SurgiMend (Cheng & St. Cyr, 2012). Vermeulen H, van Hattem JM, Storm-Versloot MN, Ubbink DT. Skovgaard C, Holm B, Troelsen A,et al. Wound Repair Regen. When applied to a wound, these devices changes the healing response, resulting in remodeled, functional, site specific tissue. 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. J Adv Nurs. A total of 82 patients were analyzed in 2 homogeneous groups. Int Wound J. Effects of human amniotic fluid on fracture healing in rat tibia. Acellular Matrix: A Matrix that is derived from sources other than human skin. Study conductd at Albany Medical Center and the University of Maryland, Institute of Human Virology through funding from Skin and Wound Allograft Institute, A Subsidiary of Lifenet Health. Alvarez OM, Smith T, Gilbert TW, et al. 2010;56(6):24-31. Randomized clinical trial on the effect of fibrin sealant on latissimus dorsi donor-site seroma formation after breast reconstruction. Modern management of complex open abdominal wounds of war: A 5-year experience. Unite Biomatrix is packaged in a chemical solution and is available pre-fenestrated or non-fenestrated. Support Care Cancer. 1997;18(1 Pt 1):43-51. Angrisani L, Cutolo PP, Buchwald JN,et al. 1998;25(3):397-405. 2016;25(6):320-325. Surg Innov. The study found no significant differences in overall complication rates in the group managed with SurgiMend (20.8%) versus the group managed without use of a graft (13.0%). The use of matriderm and autologous skin graft in the treatment of full thickness skin defects. Roth JS, Brathwaite C, Hacker K,et al. Giza E, Frizzell L, Farac R,et al. Dire consequences of the indiscriminate use of Teflon felt pledgets. 2007;34(5):521-523. 2011;21(6):783-793. Bush J, Duncan JA, Bond JS,et al. Complications following decompression of Chiari malformation Type I in children: Dural graft or sealant? Surg Technol Int. PuraPly and PuraPly AM are administered by applying the product to a wound using sutures or other fixation methods. 2007;43(6):512-515. Preoperative external tissue expansion for complex cranial reconstructions. 2010;7:349-357. J Trauma. 2013;131(5):940-951. Arthrex Amnion matrix is an anatomical barrier that helps provide mechanical protection while . Discovery and development of avotermin (recombinant human transforming growth factor beta 3):A new class of prophylactic therapeutic for the improvement of scarring. Parker MJ, Kim RC, Barrio M, et al. The most favorable estimates of product efficacy (i.e., those that were statistically significant compared with compression therapy) were used. : A systematic review of the literature. U.S. Food and Drug Administration (FDA). 2007;32(3):268-274. Spine J. Wound Repair Regen. Burns. 2019;7(8):e2371. 2006;72(12):1181-1188. Genital prolapse repair with Avaulta Plus() mesh: Functional results and quality of life. Laparoscopic repair of parastomal hernia using a porcine dermal collagen (Permacol) implant. Meyer-Ingold W. Wound therapy: Growth factors as agents to promote healing. Successful treatment of a patient with an extraordinarily large deep burn. Int Wound J. K021792. Meschia M, Pifarotti P, Bernasconi F, et al. Hiles M, Record Ritchie RD, Altizer AM. Scott BG, Welsh FJ, Pham HQ, et al. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction.