2009;9:115. K012814. The product is applied directly on or in the wound with a 20-23 gauge needle. Links to various non-Aetna sites are provided for your convenience only. Brooks DN, Weber RV, Chao JD, et al. It is comprised of dehydrated, sterile human amniotic membrane and chorionic membrane obtained from donated human placental tissue. Original Effective Date: 4/1/2013 Re-Review Date(s): 1/20/2016 6/28/2016 - administration update 2/20/2019 3/16/2020 - administrative update; format . They are typically administered in an outpatient setting but may be administered inpatient or in the office setting. Lesher AP, Curry RH, Evans J, et al. 2006;17(Suppl 1):S44-S47. Management of split-thickness donor sites with synthetic wound dressings: Results of a comparative clinical study. Cochrane Database Syst Rev. Comparative analysis of biomechanical performance of available "nerve glues". Suprathel (Polymedics Innovations GmbH, Denkendorf, Germany) is a synthetic, biocompatible, and absorbable skin substitute made from polymers of lactic acid (Snyder et al, 2012). 2012;25(12):543-547. Everts PA, Knape JT, Weibrich G, et al. J Otolaryngol Head Neck Surg. Well-controlled clinical trials are needed comparing clinical outcomes of silver-coated wound dressings with standard wound dressings in patients in various phases of burn wound care. The investigators noted that significance was not established due to sample size but further investigation with human amniotic allograft is warranted. Application Summaries for Drugs, Biologicals and Radiopharmaceuticals. Sepesi B, Moalem J, Galka E,et al. Baltimore, MD: CMS; December 2, 2021c. 2013;27(10):3654-3662. WoundEx Flow is supplied in single use: 0.5cc, 1.0 cc, 1.5 cc, 2.0 vials. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence:A prospective randomized three-year follow-up study. Br J Community Nurs. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. SurgiMend. Dantzer E, Braye FM. Centers for Medicare & Medicaid Services (CMS). Naughton G, Mansbridge J, Gentzkow G.A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Ann Med Surg (Lond). 2013;2013:849321.. Nicoletti G, Brenta F, Bleve M,et al. According to the manufacturer, Organogenesis Inc., TransCyte is a human fibroblast-derived temporary wound cover consisting of polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh (CMS, 2017). Adams E. Bibliography: Collagen-based Dressings for Chronic Wound Management. Complications with the use of Artelon in thumb CMC joint arthritis. Sarr MG, Hutcher NE, Snyder S,et al. Pichon Riviere A, Augustovski F, Ferrante D, et al. Implant Dent. In addition to this study, additional weak . Comparative analysis of urinary incontinence severity after autologous fascia pubovaginal sling, pubovaginal sling and tension-free vaginal tape. Hammond TM, Porrett TR, Scott SM,et al. 2015;4(6):e637-e641, Hirahara AM, Andersen WJ, Panero AJ. The use of an acellular porcine dermal collagen implant in the repair of complex abdominal wall defects:A European multicentre retrospective study. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050355.pdf. Huang H, Kitano K, Nagayama K,et al. AmnioRepair is indicated for use as a biological barrier or wound cover. Mericli AF, Garvey PB, Giordano S, et al. Cochrane DatabaseSyst Rev. Schiariti M, Acerbi F, Broggi M, et al. 2005;52(6):1104. Sonnad SS, Goldsack J, Mohr P, Whicher D. Methodological recommendations for comparative effectiveness research on the treatment of chronic wounds. 2004;24(2):218-226. Processed allografts and type I collagen conduits for repair of peripheral nerve gaps. Hernia. 2018;35(3):357-365. Frykberg RG, Gibbons GW, Walters JL, et al. 2011;56(10):1170-1176. 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. Ann Plast Surg. 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). 1998;176(2A Suppl):80S-82S. Accessed on February 11, 2010. Than KD, Baird CJ, Olivi A. 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. Armstrong DG, Galiano RD, Orgill DP, et al. 2014;27(11):513-516. McCall TD, Fults DW, Schmidt RH. 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. Integra LifeSciences Corp. Integra Flowable Wound Matrix [website]. Am J Sports Med. 2010;76(1):1-6. 510(k) Summary. Ostomy Wound Manage. Developed to fill soft tissue defects and bone voids and to convey anti-microbial and anti-inflammatory capabilities, granulized amniotic membrane and amniotic fluid does not require fetal death, because its procurement is performed with maternal consent during birth. Faga A, Nicoletti G, Brenta F,et al. Graftskin treatment of difficult to heal diabetic foot ulcers: One center's experience. Continuous topical oxygen for the treatment of chronic wounds: A pilot study. Procuren: A platelet-derived wound healing formula. Bowers CA, Brimley C, Cole C, et al. Baltimore, MD: CMS;May 5, 2010. Plast Reconstr Surg. Guy JS, Miller R, Morris JA Jr, et al. Arthroscopic superior capsular reconstruction for treatment of massive irreparable rotator cuff tears. 2010;5(3):273-277. Surgical treatment of complex anal fistulas with the anal fistula plug: A prospective, multicenter study. Successful treatment of a patient with an extraordinarily large deep burn. Graft for prevention of Frey syndrome after parotidectomy: A systematic review and meta-analysis of randomized controlled trials. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: Long-term follow-up. Pol Przegl Chir. Silver S, Phung le T, Silver G. Silver as biocides in burn and wound dressings and bacterial resistance to silver compounds. Open-label extension phase of a chronic diabetic foot ulcer multicenter, controlled, randomized clinical trial using cryopreserved placental membrane. Am J Surg. 2013;39(8):1577-1587. Pilot study comparing the leak pressure of the sleeved stomach with and without reinforcement. 2015;9(4):460-468. Custom sizes and thicknesses are available upon request. Jeon SH, Lee SH, Tsang YS,et al. Int Wound J. 2013;27(10):1236-1239. J Wound Care. McCollum PT, Bush JA, James G,et al. Plast Reconstr Surg. Am J Surg. Arthrosc Tech. Int J Surg. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. BIOLOGICS & SYNERGY Flashcards | Quizlet 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. 2019;17(2):131-141. 2017;43(1):195-199. 2010;20(6):397-404. 2001;54(8):659-664. Foreign body reaction to acellular dermal matrix allograft in biologic glenoid resurfacing. 2007;193(3):360-363. March 2016. Adv Skin Wound Care. Mitchell IC, Garcia NM, Barber R, et al. J Burns Wounds. The authors concluded that skin substitute usage in MMS reconstruction is not well-guided. Colorectal Dis. By providing a scaffold of extracellular matrix proteins, active growth factors and cytokines, this critical components facilitate healing and infection control. Wound Medicine. 2014;30(1):31-34. Int Wound J. naturally occurring, non-cross-linked extracellular matrix; completely resorbable; contains multiple naturally occurring growth factors; patients were followed for only 1 week following complete healing. InnovaMatrix FS. TEI Biosciences Inc., Boston, MA. Med Sci Monit. 2008;181(3):2103-10. Systematic reviews of wound care management: (2) dressings and topical agents used in the healing of chronic wounds. Arthroscopically assisted stabilization of chronic AC-joint instabilities in GraftRope technique with an additive horizontal tendon augmentation. 2013;(6):CD009111. This device was evaluated by the NICE Medical Technologies Evaluation Program. Jones JE, Nelson EA, Al-Hity A. Cochrane Database Syst Rev. There is a lack of evidence regarding the effectiveness of the XCellerate allograft. Stability is pleased to announce that our request for a Level II HCPCS code for AmnioCore Amniotic Membrane Allograft has been established . Any reference to SurFactor equally applies to NuDyn. Kumar RJ, Kimble RM, Boots R, Pegg SP. 2012;130(5 Suppl 2):256S-269S. Pediatr Dermatol. 2004;30(2):145-151. de Leon JM, Driver VR, Fylling CP,et al. Systematic review of the efficacy and safety of using mesh or grafts in surgery for uterine or vaginal vault prolapse. Br J Plast Surg. Br J Surg. 2. 2013;205(2):220-230. Delibaltov DL, Gaur U, Kim J, et al. Burns. Drug and Biological Products. AGENDA ITEM #1 1 . Coding Reference Guide AmnioRepair Allograft is a lyophilized placental membrane allograft that is aseptically processed to preserve the native extracellular matrix and endogenous proteins. Weindl G, Schaller M, Schfer-Korting M, et al. J Pediatr Surg. 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. Comparing human amniotic allograft and standard wound care when using total contact casting in the treatment of patients with diabetic foot ulcers. Abhinav K, Shaaban M, Raymond T, et al. 2010;221(4):365-372. Kirsner RS, Falanga V, Eaglstein WH. Huang LH, Neiva RE, Soehren SE, et al. The dosage of SkinTE corresponds to the surface area of the wound being treated in square centimeters. Experience with acellular human dura and bovine collagen matrix for duraplasty after posterior fossa decompression for Chiari malformations. 1993;128(11):1227-1233. 2013;84(2):153-158. operative uses of placental tissue matrix therapy in tendons and ligaments injuries; temporary wound closure (persistence of HSE with subsequent wound re-epithelialization from wound margins); and. Franklin Lakes, NJ; Collagen Matrix; 2008. Johnson W, Inamasu J, Yantzer B,et al. The authors concluded that the findings of this study showed that the use of ASCS + compression accelerated healing in large VLUs. Vin F, Teot L, Meaume S. The healing properties of Promogran in venous leg ulcers. Perit Dial Int. Repriza is a "surgical implant" and "would have no other use outside the surgical setting". Evidence Update 33. Gilot GJ, Alvarez-Pinzon AM, Barcksdale L, et al. Am J Sports Med. Acta Otorhinolaryngol Ital. 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). Effectiveness of Biobrane for treatment of partial-thickness burns in children. Reddy M. Pressure ulcers. The duration of the study was only 3weeks; thus, these researchers relied on surrogate markers for wound healing and only had 4 time-points to examine and compare changes in cytokines, perfusion, and bioburden. Foy AB, Giannini C, Raffel C. Allergic reaction to a bovine dural substitute following spinal cord untethering. Comparison of E-Z Derm and Jelonet dressings for partial skin thickness burns. Dumville JC, Deshpande S, O'Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Int Wound J. Arch Orthop Trauma Surg. 2011;7(5):637-642. Hernia. Acta Biomater. Eur J Cardiothorac Surg. There is a lack of evidence in the peer-reviewed published medical literature to support the effectiveness of Relese. The physician will size Restrata to desired configuration of the wound bed and hydrate before appropriate fixation method depending on wound type/location. 2006;57(1):1-5. 2013;(1):CD001737. Petriccioli D, Bertone C, Marchi G, Mujahed I. 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. Eur J Plast Surg. 2012;54:e132-e173. J Periodontol. Female Pelvic Med Reconstr Surg. 2013;59(12):38-43. Carlson M, Faria K, Shamis Y,et al. Non-watertight dural reconstruction in meningioma surgery: Results in 439 consecutive patients and a review of the literature. 2011;23(7):184-189. Orthopedics Today. 2019;30(4):203-209. Weber PC, Lambert PR, Cunningham CD, 3rd, et al. Clinical and economic outcomes with graftskin for hard-to-heal venous leg ulcers:A single-center experience. 2008;106(6):1619-1626. K060952. 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." 2002;961:356-359. 2012;34(1):88-93. Karr JC, Taddei AR, Picchietti S,et al. The use of a collagen sponge/living cell composite material to treat donor sites in burn patients. Clin Podiatr Med Surg. Partial and full-thickness 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; Oro-nasal fistula following cleft palate repair. 1998;16(6):246-249. Lee DK. 2013;29(1):37-55. Dermagraft treatment of diabetic ulcers. Sari E, Eryilmaz T, Tetik G, et al. J Spinal Cord Med. Am J Sports Med. 2005;16(3):349-356. The Provant Wound Closure System (Regenesis Biomedical Inc., Scottsdale, AZ) uses a low-level radiofrequency signal that proponents state accelerates healing of chronic wounds by stimulating the production of endogenous growth factors and the proliferation of fibroblasts and epithelial cells, in a process the manufacturer has labeled "Cell Proliferation Induction" or CPI. Neill J, James K, Lineaweaver W. Utilizing biologic assimilation of bovine fetal collagen in staged skin grafting. Wound Repair Regen. Endoscopic endonasal treatment of a spontaneous temporosphenoidal encephalocele with a detachable silicone balloon.
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