It is intended for the protection and treatment of non-healing wounds and burn injuries. A prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to sham therapy in the treatment of diabetic foot ulcers. J Plast Reconstr Aesthet Surg. 2007;157(7-8):170-172. 2008;17:174-180. and 5/box). Phillips LG, Robson MC, Smith DJ, et al. Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: A multicenter, randomized study. 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. Internal Clinical Guidelines Team. Sheikh ES, Sheikh ES, Fetterolf DE. Delayed primary closure of contaminated abdominal wall defects with non-crosslinked porcine acellular dermal matrix compared with conventional staged repair:A retrospective study. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis. 2014;25:73-78. J Pediatr Surg. Collagen nerve wrap. J Am Podiatr Med Assoc. A total 0f 96 children with 113 upper or lower extremity burns were included in the analysis. 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). J Dermatol. 2009;34(8):1388-1392. The ReCell was developed for POC preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient's skin to treat up to 80 cm2 of excised burn. Thomas K, Litsky A, Jones G, Bishop JY. 2009;39(6):787-799. 2012;35(12):e1759-e1764. Adelaide,SA: Joanna Briggs Institute for Evidence Based Nursing and Midwifery; 2001. 2009;9(4):e25-e29. Int J Shoulder Surg. 2020;17(3):742-752. Couture M. Does continuous diffusion of oxygen have potential in chronic diabetic foot ulcers? Insufficient information was provided regarding randomization in this study. Shaharudin A, Aziz Z. 2017;46(6):266-278, Makovicka JL, Chung AS, Patel KA, et al. Mari FS, Masoni L, Cosenza UM,et al. the cost data were obtained from a CMS reimbursement schedule, and these do not reflect the actual cost of material across all clinical settings. 1995;70(8):789-799. Veritas collagen matrix. 2005;4(4):214-224. Use of acellular dermal matrix for complicated ventral hernia repair: Does technique affect outcomes? Lancet. 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. 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. J Burn Care Res. 2022;19(5):1197-1209. Lee JM, Seo YJ, Shim DB, et al. 2003;29(8):863-866. Prospective comparative study of the efficacy of staple-line reinforcement in laparoscopic sleeve gastrectomy. 2012;22(1):42-46. 2002;11(9):335-341. Bone and tendon coverage via dehydrated human amniotic/chorionic membrane and split-thickness skin grafting. Plainsboro, NJ: Integra LifeSciences; 2008. The effect of amelogenins (Xelma) on hard-to-heal venous leg ulcers. Pain and assessments of scarring at the treatment sites were reported to be similar between groups. Acellular Matrices are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017). A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Bond E, Barrett S, Pragnell J. A clinical trial of Integra Template for diabetic foot ulcer treatment. Suprathel may also be used for partial and full thickness wounds.The Suprathel membrane is applied once to a clean dbrided wound surface and then breaks down during the healing process. Dermal autografts as a substitute for acellular dermal matrices (ADM) in tissue expander breast reconstruction:A prospective comparative study. J Burn Care Rehabil. Vashi C. Clinical outcomes for breast cancer patients undergoing mastectomy and reconstruction with use of DermACELL, a sterile, room temperature acellular dermal matrix. Effectiveness measures were evaluated and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes up to 1 year following treatment. Fibrin sealants or cell saver eliminate the need for autologous blood donation in anemic patients undergoing primary total knee arthroplasty. The cost of treatment per square centimeter for Mepilex Ag was considerably lower than that of Suprathel. Arthroscopy. Wasiak J, Cleland H. Burns (minor thermal). Centers for Medicare & Medicaid Services (CMS), Healthcare Common Procedure Coding System (HCPCS). Rockville, MD: FDA; May 15, 2006. Silver Spring, MD: FDA; April 21, 2021. Demling RH, DeSanti L. Management of partial thickness facial burns (comparison of topical antibiotics and bio-engineered skin substitutes). 2012;255(6):1037-1042. Yao M, Attalla K, Ren Y,et al. 2014;40(6):828-834. 2010;100(1):73-77. The investigators summarized the results of a per protocol interim analysis of complete wound closure at 12 weeks in a double blind 2-arm clinical trial of 84 subjects randomized 1:1 to Active CDO versus Sham, conducted when 50% of the planned number of subjects completed 12 weeks of therapy (Active 21, Sham 21). It is highly permeable to oxygen and water vapor, providing a particularly favorable environment for wound healing. Stockholm, Sweden: The Swedish Council on Health Technology Assessment (SBU); 2010. Post-excision of donor sites, all donor sites were randomly covered either with human amniotic membrane (HAM) preserved in 98% glycerol or chlorhexidine-soaked paraffin gauze with cotton gauze. It is made from human donor skin, which undergoes a process that removes the epidermis and dermal cells, thereby creating an acellular dermis. Patients in group A, with a higher mean hemoglobin A1c at study outset, experienced a longer mean time to closure (29.50) days compared with group B (26.20 days). Holmes JH, 4th, Molnar JA, Shupp JW, et al. Duerr RA, Ackermann J, Gomoll AH. Graham A. 2009;20(1):75-81. [website]. 2016;42(5):953-1021. 1995;16(3 Pt 1):317-320. J Arthroplasty. Int Urogynecol J Pelvic Floor Dysfunct. The donor human skin is processed and then freeze-dried to remove cells while maintaining the collagen, elastin, and proteoglycans. Int Wound J. The authors stated that the ReCell procedure took longer than skin grafts, mainly due to the time required by trypsin to digest intercellular bonds (20 mins). Centers for Medicare & Medicaid Services (CMS). Quiroz LH, Gutman RE, Shippey S,et al. 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. 2012;1(3):51-59. Am J Sports Med. 2012;99(10):1381-1388. Cymetra. Arthroscopy. UpToDate [online serial]. Zienowicz RJ, Karacaoglu E. Implant-based breast reconstruction with allograft. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Wound Repair Regen. 1991;213(4):292-296. This allows for easy manipulation and results in a dependable, flexible allograft. All patients received the same post-operative analgesics and with the same doses; however, those that underwent skin grafts complained of an additional painful site (the area of harvesting). Wound Medicine. Perit Dial Int. Acellular dermal matrices in abdominal wall reconstruction: A systematic review of the current evidence. World J Emerg Surg. WoundEx membrane is intended to be used as a wound covering in the treatment of chronic and acute wounds. Alvarez OM, Smith T, Gilbert TW, et al. Available evidence on CPI has focused mainly on the effects of low-level radiofrequency signals on growth factors and cell proliferation in vitro. Acellular fetal bovine dermal matrix for treatment of chronic ulcerations of the midfoot associated with Charcot neuroarthropathy. AlloDerm for duraplasty in Chiari malformation: Superior outcomes. In: BMJ Clinical Evidence. Blume O, Back M, Born T, Donkiewicz P. Reconstruction of a unilateral alveolar cleft using a customized allogenic bone block and subsequent dental implant placement in an adult patient. Llewellyn-Bennett R, Greenwood R, Benson JR, et al. FDA Safety Communication: Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Optimizing Suprathel-therapy by the use of Octenidine-Gel. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: A randomized clinical trial. 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. Alfieri A, Schettino R, Taborelli A,et al. 1996;53(4):304-308. They stated that further investigation is needed in the clinical characterization of the wounds, their healing trajectory as well as the role of wound healing interventions. Uhlig C, Rapp M, Hartmann B, et al. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Austin RE, Merchant N, Shahrokhi S, Jeschke MG. A comparison of Biobrane and cadaveric allograft for temporizing the acute burn wound: Cost and procedural time. Average VLU sizes were 1 cm2, 10 to 12 cm2, and 10 to 13 cm2 in the studies of Apligraf, Oasis, and Talymed, respectively. Stem Cells Transl Med. J Wound Care. Cervigni M, Natale F, La Penna C,et al. Pfurtscheller K, Zobel G, Roedl S, Trop M. Use of Suprathel dressing in a young infant with TEN. Following application to a wound bed, the product functions to regenerate full-thickness functional skin across the entire surface, including all layers (epidermis, dermis, hypodermis), and regenerate functional appendages native to skin. Int J Surg. At 4 weeks, 98 % of the ASCS-treated sites were healed compared with 100 % of the Controls. Centers for Medicare & Medicaid Services (CMS). The use of matriderm and autologous skin graft in the treatment of full thickness skin defects. Diabetic foot problems: Inpatient management of diabetic foot problems (Draft). UpToDate [serial online]. Injury. 2010;44(2):157-161. Sixty-two patients were randomized to Mepilex Ag (n=30) or Suprathel (n=32). Arthrex Amnion matrix Orthopedic barrier or wrap J3590 Arthrex Amnion viscous Orthopedic barrier or wrap C9250 ARTISS Wound care, burns . Healing of diabetic foot ulcers and pressure ulcers with human skin equivalent: A new paradigm in wound healing. 2010;25(4):378-382. Symbas J, McCord C, Nahai F. Acellular dermal matrix in eyelid surgery. 2011;17(3-4):487-493. The authors concluded that the most expensive AWCM for the treatment of VLUs did not appear to provide the greatest comparative clinical or cost efficacy. 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). It provides a support structure for cellular migration and as such the matrix is incorporated into the surrounding tissue. J Wound Care. Early failures with single clavicular transosseous coracoclavicular ligament reconstruction. Am J Cosm Surg. Ann Thorac Surg. 2013;100(11):1498-1504. The use of Hyalomatrix PA in the treatment of deep partial-thickness burns. Trends Biotechnol. Acta Orthop. 1997;18(1 Pt 1):43-51. Int Urogynecol J Pelvic Floor Dysfunct. 2022;19(4):932-944. These products are acellular, flowable allograft tissue matrix derived from donated human amniotic membrane. J Comp Eff Res. J Wound Care. 2011;8(2):177-183. Human acellular dermal wound matrix for treatment of DFU: Literature review and analysis. This finding needs to be verified by larger multicenter studies. Use of Alloderm in the neurotologic setting. Specifically, VIM human amniotic membrane allograft is indicated for discretionary homologous use by the physician when human amniotic membrane might be beneficial as a wound covering or barrier. Atzmon R, Radparvar JR, Sharfman ZT, et al. 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. Further studies with this synthetic dressing on other types of wounds are warranted. Int J Burns Trauma. 2017;6(2):e297-e301. Kassolis JD, Reynolds MA. Organogenesis. 2015;40(9):1009-1012. Macrophage phenotypes correspond with remodeling outcomes of various acellular dermal matrices. BJU Int. There is insufficient scientific evidence regarding the effectiveness of SurgiMend for use as an implant for the surgical repair of soft tissue deficiencies or for any other indications. This may have potentially skewed healing rates and wound duration measures towards SOC. 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. 2010;19(2 Suppl):104-109. Barber FA, Herbert MA, et al.Tendon augmentation grafts: biomechanical failure loads and failure patterns. Bello YM, Falabella AF, Eaglstein WH. Espinosa-de-los-Monteros A, de la Torre JI, Marrero I, et al. Cohen J, Jayram G, Mullins JK,et al. The Boston Scientific Web site promotes Repliform for pelvic floor repair and says it "is intended for the repair or replacement of damaged or inadequate integumental tissue such to repair enteroceles, rectoceles and/or cystoceles and for pelvic floor reinforcement.". Cochrane Database Syst Rev. Lavery LA, Niederauer MQ, Papas KK, Armstrong DG, Does debridement improve clinical outcomes in people with DFU ulcers treated with CDO? Arch Facial Plast Surg. The rate of infection was 3.8% (8/229). Surgical management of juvenile amputation overgrowth with a synthetic cap. The product is applied topically by placing the membrane over the wound or within the surgical site. In addition, achieving definitive closure using less skin compared with standard autografting has the potential to decrease the number of surgical procedures needed to achieve wound closure as well as reducing hospital LOS; therefor, decreasing the overall costs related to the treatment of burn injuries. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050355.pdf. Int Wound J. 2015;73(10):1888-1893. Stamou KM, Menenakos E, Dardamanis D,et al. They function in support of wound healing and soft tissue repair and are indicated for use in patients with acute, chronic or non-healing wounds, burns, or surgical wounds and in patients with soft tissue injuries or inflammatory conditions such as plantar fasciitis, bursitis, tendonitis, ligament and tendon sprains, nerve entrapment and ankle capsulitis. Hand (N Y). These researchers evaluated 23 patients for 3weeks. According to the manufacturer's website, TenoGlide provides a protective biocompatible interface, which provides a protective environment and gliding surface while the tendon is healing (e.g., tendons damaged by compression from trauma or after primary repair). Plast Reconstr Surg. J Neurosurg. Int Braz J Urol. Sclafani AP, Romo T 3rd, Jacono AA. 2008;181(3):2103-10. 2016;45(9):1159-1161. J Thorac Cardiovasc Surg. Carlson M, Faria K, Shamis Y,et al. J Shoulder Elbow Surg. Ward KC, Costello KP, Baalman S,et al. 2000;16 Suppl 1:S51-S54. ReCell is a medical device that processes skin samples in the operating room into a cell suspension to be sprayed on or dripped onto a wound. They are typically administered in an outpatient setting but may be administered inpatient or in the office setting. Successful treatment of a patient with an extraordinarily large deep burn. 2005;76(11):1814-1822. Pseudarthrosis was defined as abnormal movement between the spinous processes, lucency at the graft vertebral body interface or absence of trabecular bone spanning the complete fused space. Liyanage SH, Purohit GS, Frye JN, Giordano P. Anterior abdominal wall reconstruction with a Permacol implant. 2002;28(1):81-82. Effectiveness of Biobrane for treatment of partial-thickness burns in children. The study focused on the need for subsequent grafting, healing time, patient pain level, hypertrophic scarring and rate of infection. Stability of double-row rotator cuff repair is not adversely affected by scaffold interposition between tendon and bone. 2008;121(4):1256-1262. Zidan et al performed a single center prospective randomized controlled trial in Egypt consisting of 40 patients with thermal burns or trauma undergoing STSG. Comparison of dermal substitutes in wound healing utilizing a nude mouse model. The manufacturer analyzed the interim data and discovered that, if one excludes smaller lesions at baseline and wounds that were rapidly healing during the two-week run-in period from the analysis, statistical significance could be achieved. Suprathel-acetic acid matrix versus acticoat and aquacel as an antiseptic dressing: An in vitro study. Are biologic grafts effective for hernia repair? Centers for Medicare & Medicaid Services' (CMS') First Biannual 2022 Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda. Human fibroblast-derived dermal substitute: Results from a treatment investigational device exemption (TIDE) study in diabetic foot ulcers. Musculoskelet Surg. 2013;(6):CD009100. Int Surg. J Manag Care Pharm. The use of PriMatrix, a fetal bovine acellular dermal matrix, in healing chronic diabetic foot ulcers: A prospective multicenter study. BioGlue and Peri-strips in lung volume reduction surgery: Pilot randomised controlled trial. 2012;50(2):165-169. It is held in place by hydrostatic tension. 2012;19(3):325-330. Werber B, Martin E. A prospective study of 20 foot and ankle wounds treated with cryopreserved amniotic membrane and fluid allograft. Muscle Nerve. Satterwhite TS, Miri S, Chung C,et al. T he tissue is treated using the Tutoplast sterilization procedure to kill bacteria, destroy cells, remove prions, and reduce potential tissue rejection. The authors found that there was no significant difference between the 2 materialstested regarding healing time and reepithelization. Armitage S, Seman EI, Keirse MJ. Does the addition of a nerve wrap to a motor nerve repair affect motor outcomes? Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Q4185 Cellesta flowable amnion (25 mg per cc); per 0.5 cc (New Code Effective 1/1/2019) 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 Thus, the results of this pivotal study would be considered hypothesis generating. Eur J Oral Implantol. 2007;(1):CD005486. J Am Acad Dermatol. Cazzell S, Vayser D, Pham H, et al. Gauglitz GG, Williams FN. In a retrospective, propensity matched-cohort study, Gurtner and colleagues (2020) examined data from 2,074,000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1,997) versus SOC alone (n = 1,997). Burns. Holmes JH, IV, Molnar JA, Carter JE, et al. 2014;7(5):15-8. There is a lack of evidence on the effectiveness of Pro3-C amniotic membrane for wound care. The high failure rate of biologic resurfacing of the glenoid in young patients with glenohumeral arthritis. 2013;4:26. 2008;63(1 Suppl 1):ONS182-ONS186; discussion ONS186-ONS187. For example, it may be used to support implants in a defined pocket such as in breast reconstruction, and abdominal wall reconstruction procedures. Driver VR, Reyzelman A, Kawalec J, French M. A prospective, randomized, blinded, controlled trial comparing transdermal continuous oxygen delivery to moist wound therapy for the treatment of diabetic foot ulcers. According to the manufacturer, Human Regenerative Technologies, LLC.,WoundFix XPlus Membrane and BioWound XPlus Membrane are single layer human placental tissue-based membranesintended to be used 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 (CMS, 2019). The finished allograft is between 0.2 to 0.5 mm in thickness and contains both human epidermis and dermis tissues. Jensen G, Katthagen JC, Alvarado L,et al. 2019;12(2):173-180. The result illustrated in the intent-to-treat analysis at 12 weeks showed that 76% (38/50) of the TheraSkin-treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). Furthermore, these researchers did not measure the duration of therapy in minutes or hours. Hubik DJ, Wasiak J, Paul E, Cleland H. Biobrane:A retrospective analysis of outcomes at a specialist adult burns centre. 2015;19(7):411-417. A comparative histologic study. Ann Plastic Surg. #: OF1-000312-en-USVersion: GLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for Hand/Wrist Anchors Soft Tissue ImplantsFile Type: Ref. Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. Salivary gland tumors: Treatment of locoregional disease. 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. Mallinckrodt Pharmaceuticals. Hur GY, Seo DK, Lee JW. Microsurgery. Wound Repair Regen. 1996;183(1):61-64. Gerdisch MW, Boyd WD, Harlan JL,et al. 2004;62(4):489-496. Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis. A comparative study of the ReCell device and autologous spit-thickness meshed skin graft in the treatment of acute burn injuries. Gravante et al (2007) compared results obtained with the ReCell system and the classic skin grafting for epidermal replacement in deep partial thickness burns. Wounds 2017;29(7):E51-E54. Graft choices for acetabular labral reconstruction. Wound Repair Regen. Polyethylene glycol hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair in the spine: Results of a prospective, multicenter, randomized controlled study. Dehydrated amnion/chorion grafts are currently used to treat a variety of wounds such as diabetic foot ulcers (DFUs) and burns. WoundFix XPlus Membrane and BioWound XPlus Membrane are supplied in single-use packaging, in 6 sq. Marston WA, Lantis JC, 2nd , Wu SC, et al. A randomized, prospective study of the treatment of superficial partial-thickness burns: AWBAT-S versus Biobrane. Memphis, TN: Triad Life Sciences; 2021. Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers. 2012;130(5 Suppl 2):183S-193S. Biological materials in chest wall reconstruction: Initial experience with the Peri-Guard Repair Patch. Am J Orthop (Belle Mead NJ). A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Bergstrom N, Bennett MA, Carlson CE, et al. Kirsner RS, Falanga V, Eaglstein WH. WoundEx membrane allograft consists of dehydrated and decellularized human amniotic membrane that has been processed with proprietary HydraTek technology.

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