There were no differences in quantitative cultures in healers and non-healers. 2013;17(5):609-611. 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. Burn injuries were randomly selected, partly treated with Omiderm (a polyurethane membrane) and partly treated with Suprathel. Montreal, QC: Technology Assessment Unit of the McGill University Health Centre (MUHC); 2012. Parker MJ, Kim RC, Barrio M, et al. Immediate single-stage reconstruction of the breast utilizing FlexHD and implant following skin-sparing mastectomy. 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. Pelvic, abdominal, and chest wall reconstruction with AlloDerm in patients at increased risk for mesh-related complications.
PDF Centers for Medicare & Medicaid Services (CMS) Healthcare Common 1,2 1. Available at: http://www.microvas.com/surgerymag.html. Glat P, Orgill DP, Galiano R, et al. A prospective comparison of diabetic foot ulcers treated with either cryopreserved skin allograft or bioengineered skin substitute. A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients. Hirsh F, Berlin SJ, Holtz A. Transdermal oxygen delivery to diabetic wounds: A report of 6 cases. Wong I, Burns J, Snyder S. Arthroscopic GraftJacket repair of rotator cuff tears. Complications in tissue expander breast reconstruction:A comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ely EE, Figueroa NM, Gilot GJ. Human acellular dermal matrix for repair of abdominal wall defects: Review of clinical experience and experimental data. Schneider KH, Aigner P, Holnthoner W, et al. A prospective, randomized trial of Acticoat versus silver sulfadiazine in the treatment of partial-thickness burns: which method is less painful? Sheffield, UK: University of Sheffield; 2003. It is intended to provide a protective barrier while providing a regenerative tissue matrix with anti-inflammatory, anti-scarring and anti-microbial properties to facilitate healing of chronic, non-healing wounds and burns. 2017;14(6):993-1005. 2015;28(10). Arch Oral Biol. 2008;181(3):2103-10. This protective dressing should comprise a fatty gauze and absorbent gauze. Walters J, Cazzell S, Pham H, et al. Furthermore, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control. 1991;21(50):34, 36. 2017;14(6):1066-1075. 2014;37(10):529-538. A benefit of selecting the 644 affiliated centers is that it ensures consistency in reporting as well as the clinical practice. J Tissue Eng Regen Med. Musculoskeletal Transplant Foundation (MTF). 2008;(4):CD002106. A clinical experience. The authors reported that the duration of drainage was significantly shorter in the group managed with SurgiMend (8.5 days) versus the comparison group (11 days). Clinical and in vitro responses of bilayered skin construct (graftskin) to meshing. Am J Clin Dermatol. J Knee Surg. Angrisani L, Cutolo PP, Buchwald JN,et al. Int Wound J. 2012;25(6):253-260. Management of defects on lower extremities with the use of matriderm and skin graft. Ann Burns Fire Disasters. Baltimore, MD: CMS; March 30, 2022. 2012;14(9):1152-1153. Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: A long-term follow-up study. Proposed decision memo for autologous blood derived products for chronic non-healing wounds (CAG-00190R2). The honeypot study protocol:A randomized controlled trial of exit-site application of medihoney antibacterial wound gel for the prevention of catheter-associated infections in peritoneal dialysis patients. Typically this is accomplished by the suturing or stapling the allograft to the skin surrounding the wound. Surg Endosc. Scalp reconstruction using dermal induction template: State of the art and personal experience. Wound Repair Regen. Robson MC, Mustoe TA, Hunt TK. Factors influencing success of pelvic organ prolapse repair using porcine dermal implant Pelvicol. 2011;13(6):569-572. 2020;9(1):23-34. Capito AE, Tholpady SS, Agrawal H, et al. Asdressing material, Omiderm is more cost-effective than Suprathel. K062915. Pugliese R, Maggioni D, Sansonna F,et al. Technology Assessment Program: Skin substitutes for treating chronic wounds. Restrata is a wound matrix that is classified as a skin substitute. The combination of polytetrafluoroethylene mesh and titanium rib implants: An innovative process for reconstructing large full thickness chest wall defects. Graft choices for acetabular labral reconstruction. Guidance on the use of debriding agents and specialist wound care clinics for difficult to heal surgical wounds. They evaluated as primary endpoints of the study the time for complete epithelization (both treated area and biopsy site) as well as aesthetic and functional quality of the epithelization (color, joint contractures). Treatment with the Provant System is usually administered for 30 mins right through dressing twice-daily. Use of resorbable collagen dural substitutes in the presence of cranial and spinal infections-report of 3 cases. Open J Regen Med. Bowering K, Embil JM. 2016;25(10):585-592. Available at: http://www.microvas.com. 1993;32(3):263-268. Cochrane DatabaseSyst Rev. The use of biosynthetic mesh to enhance hiatal repair at the time of redo Nissen fundoplication. ; Grafix Diabetic Foot Ulcer Study Group. Improved time-zero biomechanical properties using poly-L-lactic acid graft augmentation in a cadaveric rotator cuff repair model. J Oral Maxillofac Surg. Cheng AW, Abbas MA, Tejirian T. Outcome of abdominal wall hernia repair with biologic mesh: Permacol versus Strattice. Ann Coloproctol. Trapezium prosthetic arthroplasty (silicone, Artelon, metal, and pyrocarbon). AmnioRepair is indicated for use as a biological barrier or wound cover. 2010;53(1):88-92. Thoracic wall reconstruction with Collamend in trauma: Report of a case and review of the literature. Yamamoto M, Hayashi MS, Nguyen NT,et al. The amniotic membrane allograft is immune-privileged and possesses little or no risk of foreign body reaction, which can lead to fibrosis and graft failure. Purdue GF, Hunt JL, Still JM Jr,et al. 2014;29(9):1125-1130. Patients who received either a bilayer cellular construct (BLCC), dermal skin substitute (DSS), or cryo-preserved human skin allograft (CHSA) were concurrently matched for Charlson Comorbidity Index (CCI), age, sex, and region, resulting in 14,546 study patients. Fette A. Integra artificial skin in use for full-thickness burn surgery: Benefits or harms on patient outcome. Donated human tissue. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy:A single-blinded, randomized controlled trial. #: DOC1-000543-en-USVersion: ELanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for CuffMend Rotator Cuff Repair Augmentation SystemFile Type: Ref. 2006;88(12):2665-2672. 2013;22(7):347-348, 350-351. Plast Reconstr Surg. Wasiak J, Cleland H. Burns (minor thermal). Acta Orthop. WoundFix Plus and BioWound Plus membrane are supplied in single use packaging in sizes ranging from .786 to 192 sq. Contracture of skin graft in human burns: Effect of artificial dermis. Martin BR, Sangalang M, Wu S, Armstrong DG. J Burn Care Res. At Week 14, VLUs treated with ASCS + compression had a statistically greater decrease in ulcer area compared with the Control (8.94 cm2 versus 1.23 cm2, p = 0.0143). Limitations of this study include small sample size, omission of reporting certain important baseline variables and outcomes, and lack of blinding of persons assessing outcomes. Surg Endosc. 2000;142(5):557-561. March 2016. WoundFix XPlus Membrane and BioWound XPlus Membrane are supplied in single-use packaging, in 6 sq. ; 3 cm x 3.5 cm (5/box) and (10/box); 3 cm x 7 cm (5/box and 10/box); 7 cm x 10 cm (1 ea. The specimens were divided into 5 groups. No. Third Quarter, 2022 HCPCS Coding Cycle. An unusual response associated with cross-linked porcine dermal collagen (ENDURAGen) used for reconstruction of a post-traumatic lateral nasal wall deformity. Plast Reconstr Surg. Repair of high-risk incisional hernias and traumatic abdominal wall defects with porcine mesh. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. 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. Dara E, Coutant C, Rouzier R,et al. The need in dural graft suturing in Chiari I malformation decompression: A prospective, single-blind, randomized trial comparing sutured and sutureless duraplasty materials. 2013; 21(4):503-511. The investigators reported that complete wound closure at 12 weeks, the primary study endpoint, was not significantly associated with treatment per protocol [Active 11 (52.3%), Sham 8 (38.1%), RR 1.38 (95% CI 0.7, 2.7), p = 0.54]. Hyaluronic acid three-dimensional scaffold for surgical revision of retracting scars: A human experimental study. J Periodontol. U.S. Food and Drug Administration (FDA). Am J Surg. 2003;69(12):1025-1029. Use of duraseal in repair of cerebrospinal fluid leaks. NICE clinical guideline. AmnioRepair is a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271. . J Wound Care. Ann Plast Surg. 2016;45(5):320-324. News Release. Accessed December 15, 2008. 2013;52(5):615-621. Gurtner GC, Garcia AD, Bakewell K, Alarcon JB. Karr JC, Taddei AR, Picchietti S,et al. Still J, Glat P, Silverstein P, et al. TheraSkin is regulated by the FDA as a human cellular and tissue based product. Bello YM, Falabella AF, Eaglstein WH. Adams CR, Denard PJ, Brady PC, et al. SurgiMend. The arthroscopic superior capsular reconstruction. Tettelbach W, Cazzell S, Reyzelman AM, et al. Kissane NA, Itani KM. J Bronchology Interv Pulmonol. 2015;4(6):e833-e839. 2011;36(1):116-120. J Burns Wounds. Integra in lower extremity reconstruction after burn injury. Arunkalaivanan AS, Barrington JW. Suprathel becomes transparent when applied, thus allowingclose monitoring of wound healing. Hsu PW, Salgado CJ, Kent K, et al. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Stockholm, Sweden: SBU; 2003. World J Surg Oncol. Once rehydrated, the allograft can be applied topically to the wound and secured in the preferred manner of choice by the physician. Management of late complications of head and neck cancer and its treatment. 2013;217(6):999-1009. The future of recombinant growth factors in wound healing. Another potential drawback was the lack of direct comparison to other advanced treatment modalities for diabetic wounds. Schreml S, Szeimies RM, Prantl L. Oxygen in acute and chronic wound healing. 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. -load sharing device. They are available in 0.5 cc, 1 cc and 2 cc dose sizes. Montreal, QC: AETMIS; 2000. Namdari S, Melnic C, Huffman GR. De SK, Reis ED, Kerstein MD. J Plast Reconstr Aesthet Surg. Veves A, Sheehan P, Pham HT. Krishnamoorthy L, Harding K, Griffiths D, et al. Agrawal V. Healing rates for challenging rotator cuff tears utilizing an acellular human dermal reinforcement graft. Herndon DN, Nguyen TT, Gilpin DA. Healthcare Common Procedure Coding System (HCPCS). TissueMend soft tissue repair matrix. Hankin CS, Knispel J, Lopes M,et al. Furukawa K, Pichora J, Steinmann S,et al. The authors stated that this study had several drawbacks. PROVANT Wound-Closure System accelerates closure of pressure wounds in a randomized, double-blind, placebo-controlled trial. Swedish Council on Technology Assessment in Health Care (SBU). 2011;18(3):274-277. 2011;25(11):3526-3530. 2002;137(7):822-827. Biologic grafts for ventral hernia repair:A systematic review. Quintessence Int. Acellular fetal bovine dermal matrix for treatment of chronic ulcerations of the midfoot associated with Charcot neuroarthropathy. Ostomy Wound Manage. 2012;38(3):307-318. Wangensteen KJ, Kalliainen LK. 1997;18(1 Pt 1):43-51. 2014;77(3 Suppl 2):S204-S207. 2019;47(8):1901-1908. van der Meijden OA, Wijdicks CA, Gaskill TR, et al. The study focused on patient painscore, healing time, analysis of wound bed, ease of care, andtreatment costs. Growth factors. Patton JH Jr, Berry S, Kralovich KA. WoundEx Flow (Skye Biologics) consists of placental connective tissue matrix intended to replace or supplement damaged or inadequate connective tissue (CMS, 2017). Promethean LifeSciences, Inc. GammaGraft [website]. Janis JE, O'Neill AC, Ahmad J,et al. Balayssac D, Poinas AC, Pereira B, Pezet D. Use of permacol in parietal and general surgery:A bibliographic review. TransCyte consists of human dermal fibroblasts grown on nylon mesh, combined with a synthetic epidermal layer. The investigators cited four studies (i.e., Saleh et al, Singh et al, Zidan et al, and Loefebellian et al) comparing human amniotic membrane with routine dressings for split-thickness skin grafts (STSGs) with primary outcomes measured as wound healing and infection rate. Apligraf (graftskin). Robinson PM, Muir LT. Foreign body reaction associated with Artelon: Report of three cases. Use of fish skin graft in management of combat injuries following military drone assaults in field-like hospital conditions. Arch Bone Jt Surg. Surg Endosc. Burns. Tredget EE, Shankowsky HA, Groeneveld A, et al. Open repair of isolated traumatic subscapularis tendon tears with a synthetic soft tissue reinforcement. A total of 82 patients were analyzed in 2 homogeneous groups. The use of a collagen sponge/living cell composite material to treat donor sites in burn patients. There is a lack of evidence regarding the effectiveness of Revita. It was possible that these factors may have varied between the cohorts. Further studies with this synthetic dressing on other types of wounds are warranted. Moore MA, Samsell B, Wallis G, et al. Suprathel, a new skin substitute, in the management of donor sites of split-thickness skin grafts: Results of a clinical study. Giuffrida AY, Gyuricza C, Perino G, Weiland AJ. 2011;25(1):39-43. Cochrane DatabaseSyst Rev. 1998;16(6):246-249. 2012;68(5):451-456. 2002;28(8):698-703. Williams LE, Vannemreddy PS, Watson KS, Slavin KV. Chicago, IL: BCBSA; November 2001;16(12). Kavros SJ. XCellerate (Precise Bioscience) is a lyophilized amniotic membrane allograft that is aseptically processed to preserve the native extracellular matrix and endogenous proteins that can be used as a biological barrier or wound cover. Silver Spring, MD: FDA; September 21, 2018. 1996;53(4):304-308. Br J Surg. Artificial skin grafts in chronic wound care: A meta-analysis of clinical efficacy and a review of cost-effectiveness. DeNoto G, 3rd. 2008;17:174-180. 2007;205(5):654-660. Bishop JF. Cochrane DatabaseSyst Rev. Br J Community Nurs. Coding Guides (29) 2023 Coding and Reimbursement Guide for the NanoScope Operative Arthroscopy SystemFile Type: Ref. London, UK: NICE;August 26, 2015. Int J Mol Med. Zastrow RK, London DA, Parsons BO, Cagle PJ. TheraSkin has been used for repair of human skin, including dehisced surgical wounds, diabetic foot ulcers, necrotizing fasciitis, pressure ulcers, radiation burns and venousstasis ulcers. Orthopedics. J Plast Reconstr Aesthet Surg. The use of growth factors in clinical practice. Aldehyde-treated porcine skin versus biobrane as biosynthetic skin substitutes for excised burn wounds: Case series and review of the literature. 2015;157(3):507-511. The use of CorMatrix extracellular matrix for aortic root enlargement. 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. London, UK: NICE; April 2001. Podiatr Manag. J Shoulder Elbow Surg. Supplies and Other. A comparative, long-term assessment of four soft tissue substitutes. Mallinckrodt Pharmaceuticals. TheraGenesis is available as a single-use, bi-layered wound matrix. Procenta (Lucina BioSciences, LLC) is an acellular, sterile, human placental-derived allograft. Nicolau I, Xie X, McGregor M, Dendukuri N. Evaluation of acellular dermal matrix for breast reconstruction: An update. Tissue-engineered skin. Surg Obes Relat Dis. Conn Med. Use of acellular dermal matrix for reconstruction of massive rotator cuff tears in an older population. 2013;(5):CD009907. J Otolaryngol Head Neck Surg. J Mech Behav Biomed Mater.
PDF Drugs, Biologicals and Radiopharmaceuticals - Centers for Medicare Am Surg. This device was evaluated by the NICE Medical Technologies Evaluation Program. Insufficient details of randomization was noted in this study. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence:A prospective randomized three-year follow-up study. A prospective multicentre observational study of Permacol collagen paste for anorectal fistula: Preliminary results. 2006;93(7):810-819. 2009;22(2):68-71. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than SOC. A total of 687 patients were included. Enduragen patch grafts for exposed orbital implants. Cultured epithelial autografts in extensive burn coverage of severely traumatized patients: A five year single-center experience with 30 patients. Santiago GF, Bograd B, Basile PL, et al. Albanopoulos K, Alevizos L, Flessas J,et al. Urethral support with PelviSoft after artificial urinary sphincter erosion at revision procedures. Integra LifeSciences Corp, Plainsboro, NJ. Ostomy Wound Manage. Modern management of complex open abdominal wounds of war: A 5-year experience. In this context, patients with greater burns would probably benefit more with this procedure. StrataGraft is a bioengineered, allogeneic, cellularized scaffold product. Surg Innov. Burns. 2013;74(2):103-107. Schwandner T, Roblick MH, Kierer W,et al. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. Collagen matrix (DuraGen) in dural repair: Analysis of a new modified technique. There are few published reports of SurgiMend (Cheng & St. Cyr, 2012). World Neurosurg. Green AL, Arnaud A, Batiller J,et al. A randomized trial comparing RECELL system of epidermal cells delivery versus classic skin grafts for the treatment of deep partial thickness burns. 2022a;10(12):e4707. Budny AM, Ley A. Cryopreserved allograft as an alternative option for closure of diabetic foot ulcers. Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. 2015;135(1):29e-42e. The finished allograft is between 0.2 to 0.5 mm in thickness and contains both human epidermis and dermis tissues. Repriza is a "surgical implant" and "would have no other use outside the surgical setting". The Signature APatch is a cryopreserved, minimally engineered amniotic membrane allograft for homologous precision cut matrix for direct application as a would cover or physical barrier to acute or chronic wounds, including but not limited to venous leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds, burns, and wounds with exposed tendon, muscle, and/or bone. Detailed results on 2 large datasets containing membrane and nuclei data were presented: Cytal Burn Matrix (formerly MatriStem Burn Matrix)is a porcine-derived, naturally occurring dehydrated extracellular matrix, also known as urinary bladder matrix,that maintains and supports a healing environment for wound management. 2013;56(6):774-779. American Burn Association. 2012;2012:376251. 2006;19(6):310-322. Montreal, QC: Technology Assessment Unit of the McGill University Health Centre (MUHC); 2009. Am J Orthop (Belle Mead NJ). Statistical analysis was performed via analysis of variance followed by Tukey-Kramer post hoc pair-wise comparison when indicated. 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.