Jansen LA, De Caigny P, Guay NA,et al. Burns. Rayman G, Vas P, Dhatariya K, et al. Int Wound J. Long-term patients reported higher satisfaction with ReCell donor site outcomes compared with the Controls. 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. Sports Med Arthrosc. 002). Advanced biological therapies for diabetic foot ulcers. Suprathel (Polymedics Innovations GmbH, Denkendorf, Germany) is a synthetic, biocompatible, and absorbable skin substitute made from polymers of lactic acid (Snyder et al, 2012). Sheth U, Simunovic N, Klein G,et al. . #: OF1-000177-en-USVersion: GLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for the Corkscrew AnchorsFile Type: Ref. HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers:A prospective, multicenter, controlled, randomized clinical trial. Silver dressings for the treatment of patients with infected wounds:A review of clinical and cost-effectiveness. Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). 2013;59(12):38-43. "SurGraft is directed for use in patients with acute or chronic wounds, including but not limited to, chronic, non-infected, diabetic foot ulcers, chronic, non-infected, partial or full-thickness diabetic foot skin ulcers (due to venous insufficiency), pressure ulcer, surgical wounds and burns which have not adequately responded to conventional therapy." 2005;140(6):549-560; discussion 560-562. InnovaMatrix AC is the first-ever placental-derived medical device cleared by the FDA for wound management.. 1998;65(1):217-219. J Reconstr Microsurg. Donated human tissue. Prepared by the Health Services Research Unit, University of Aberdeen for the National Institute for Health and Clinical Excellence Interventional Procedures Programme. Sari E, Eryilmaz T, Tetik G, et al. TheraSkin is regulated by the FDA as a human cellular and tissue based product. J Burn Care Res. The two products are prescribed by a physician or other qualified health care professional and indicated for the management of wounds. Boston, MA: Integra TEI Biosciences; 2008. Amputation rates among patients with DFUs was a reflection of the severity of the ulceration, speed of wound closure, vascular status, patient compliance, infection, and a host of other factors that play a role in wound healing. 2013;34(10):1332-1339. Utility of acellular allograft dermis in the care of elderly burn patients. J Urol. TAG is applied directly to the wound after standard wound preparation and may be held in place using a secondary dressing. These biomaterials are used surgically for a wide range of regenerative medicine applications, including sports medicine applications such as tendon augmentation and rotator cuff repair, which call for especially robust and resilient dermal matrix materials that will resist suture pullout. 2023 Feb 15 [Online ahead of print]. In this context, patients with greater burns would probably benefit more with this procedure. Craft RO, May JW Jr. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2013. 2017;14(6):993-1005. Revitalon can be used as a covering for full-thickness wounds, damaged membranes, and as a dressing for burns. AHCPR Pub. A morphological and biochemical analysis comparative study of the collagen products Biopad, Promogram, Puracol, and Colactive. A primary consideration when using this biomaterial in-vivo is its biocompatibility and immunogenicity, both of which influence its incorporation into the surrounding tissue. Alvarez OM, Makowitz L, Patel M. Venous ulcers treated with a hyaluronic acid extracellular matrix and compression therapy: Interim analysis of a randomized controlled trial. 2003;24(1):42-48. J Shoulder Elbow Surg. Clin Plast Surg. Use the current applicable CPT/HCPCS code(s). An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial. Asian Cardiovasc Thorac Ann. J Wound Care. Analysis of run-in and treatment data in a wound outcomes registry: Clinical impact of topical platelet-rich plasma gel on healing trajectory. #: OF1-000327-en-USVersion: FLanguage: EnglishRevision Date: 02/27/2023 2023 Coding and Reimbursement Guidelines for the SwiveLock ACL Repair KitFile Type: Ref. J Pediatr Surg. Loefebellian et al performed a randomized controlled trial in Germany consisting of 45 patients undergoing STSG. Biological allograft healing after superior capsule reconstruction. Advantage of the presence of living dermal fibroblasts within in vitro reconstructed skin for grafting in humans. Public Meeting Summary Report. Gutierrez-Moreno S, Alsina-Gibert M, Sampietro-Colom L, et al. 2009;144(10):894-899. XCellerate Amniotic Membrane Allograft delivers cytokines, proteins and growth factors to help regenerate soft tissue. Bone and tendon coverage via dehydrated human amniotic/chorionic membrane and split-thickness skin grafting. Vanstraelen P. Comparison of calcium sodium alginate (KALTOSTAT) and porcine xenograft (E-Z DERM) in the healing of split-thickness skin graft donor sites. Ann Plast Surg. DiDomenico LA, Orgill DP, Galiano RD, et al. 2006;88(12):2665-2672. Both groups received standardized care that included glucose monitoring, weekly debridement's as appropriate, and an offloading device. Int Wound J. 2015;28(12). Comparative evaluation of the antimicrobial activity of ACTICOAT antimicrobial barrier dressing. Newport News, VA: Soluble Systems; revised April 22, 2011. The RECELL Autologous Cell Harvesting Device (RECELL) is a stand-alone, battery powered cell separation device that requires operation by a licensed healthcare professional the patients point of care. Arch Dermatol. Injectable skin fillers. 510(k) Summary. Collagen fistula plug for the treatment of anal fistulas. LifeCell also produces Repliform, which seems to be the same product as AlloDerm (Snyder, et al., 2012). Ann Plast Surg. 2015;28(1):17-20. Vitale MA, Taylor F, Ross M, Moran SL. 2009;152(2):281-287. Each matrix provides the same amount of human keratin proteins per square centimeter of product. Acellular nerve allografts in peripheral nerve regeneration: A comparative study. Carter MJ, Fylling CP, Li WW,et al. HCPCS codes not covered for indications listed in the CPB : AlloStem; Arthrex biopaste (BioCartilage); ChronOS bone graft substitute, . Support Care Cancer. Collagen Matrix, Inc., Franklin Lakes, NJ. 2013;40(4):403-408. The manufacturer states that SkinTE is patient and case specific, intended for autologous use, and single application only. 2009;6(3):226-232. Hernia. Vollebregt A, Fischer K, Gietelink D, van der Vaart CH. In this study, these investigators reviewed a series of 1,416 patients carried out by a single surgeon between May 2001 and February 2008. BMC Bioinformatics. Pennington WT, Chen SW, Bartz BA, Pauli JM. Lavery L, Fulmer J, Shebetka KA, et al. An in vitro study of the anti-microbial efficacy of a 1% silver sulphadiazine and 0.2% chlorhexidine digluconate cream, 1% silver sulphadiazine cream and a silver coated dressing. Furthermore, studies would need to assess if CPI adds to the effectiveness of standard methods of chronic wound management. Int J Oral Maxillofac Surg. Spinal Cord. Accessed July 1, 2009. Petri M, Greenspoon JA, Millett PJ. 2009;39(6):787-799. Operative applications of placental tissue matrix in orthopaedic sports injuries: A review of the literature. Acellular dermal matrix allograft: An effective adjunct to oronasal fistula repair in patients with cleft palate. 2006;14(3):185-190. 2002;961:356-359. Platelet-rich plasma: Evidence to support its use. Accessed January 21, 2022. #: OF1-000181-en-USVersion: GLanguage: EnglishRevision Date: 02/24/2023 Cartiform Viable Osteochondral Allograft Reimbursement Guide 2022File Type: Ref. AlloPatch Pliableallograft dermal matrix. A subsequent report of this trial (Niederauer, et al., 2017) focused on the per protocol analysis of the previously described trial of the effect of CDO on the primary outcome of full wound closure by 12 weeks, as well as the secondary outcome of rate of wound closure. These researchers concluded that interventions that improve healing time, reduce recurrent ulceration and the incidence of major limb amputations in patients with diabetesrelated foot wounds remain a priority. Wounds. These subjects with smaller lesions and more rapidly healing lesions during the run-in period were excluded from the subsequent report of the per protocol analysis of the completed trial by Niederauer, et al., 2017. Mihata T, McGarry MH, Pirolo JM, et al. A followup definitive study, which excludes subjects with smaller lesions and subjects with more rapidly healing lesions, is necessary to test the hypothesis that the TransCu O2 device is most effective in subjects with larger, more slowly healing lesions. Buttressing the staple line:A randomized comparison between staple-line reinforcement versus no reinforcement during sleeve gastrectomy. Orthopedics Today. Talymed is placed on the open wound and covered with a transparent dressing. Agence d'Evaluation des technologies et des Modes d'Intervention en Sante (AETMIS). Cochrane Database Syst Rev. The investigators monitored time to reepithelialization, wound pain, discomfort during dressing changes, and treatment cost. Burns. Dermatol Surg. Humanitarian Device Exemption No. Mansfield, MA: Covidien; 2009. A comparative study of the ReCell device and autologous spit-thickness meshed skin graft in the treatment of acute burn injuries. Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. 2005;16(3):349-356. A clinical experience. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions. J Craniomaxillofac Surg. 1997;18(2):147-155. 2006;212(3):258-259. 2019;7(1):3-11. 2012;38(3):388-395. 2019;77(10):2127.e1-2127.e11. The primary endpoint was proportion of full-thickness wounds healed at 12 weeks, with secondary endpoints including differences in percent area reduction (PAR) at 12 weeks, changes in Semmes-Weinstein monofilament score, VAS pain, and w-QoL. J Am Coll Surg. Int Wound J. Organogenesis. A novel topical oxygen treatment for chronic and difficult-to-heal wounds: Case studies. Wu XL, Briggs L, Murrell GA. Intraoperative determinants of rotator cuff repair integrity: An analysis of 500 consecutive repairs. Frykberg RG, Cazzell SM, Arroyo-Rivera J, et al. Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting. Healing of diabetic foot ulcers and pressure ulcers with human skin equivalent: A new paradigm in wound healing. Armstrong DG, Orgill DP, Galiano RD, et al. Int J Surg. Buinewicz B, Rosen B. Acellular cadaveric dermis (AlloDerm):A new alternative for abdominal hernia repair. 2008;29(3):329-333. The control group was 2.75 times more likely to require amputation than the treatment group. Ellis CV, Kulber DA. 2014;14:e36. Comparison of the antioxidant properties of wound dressing materials -- carboxymethylcellulose, hyaluronan benzyl ester and hyaluronan, towards polymorphonuclear leukocyte-derived reactive oxygen species. 2012;66(6):e209-e215. Biologic mesh for abdominal wall reconstruction:A critical appraisal. Brooke S, Mesa J, Uluer M,et al. According to the manufacturer, Human Regenerative Technologies, LLC., WoundEx consists of placental connective tissue matrix intended to replace or supplement damaged or inadequate connective tissue (CMS, 2017). Bibevski S, Scholl FG. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes. Surg Technol Int. #: DOC1-000543-en-USVersion: ELanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for CuffMend Rotator Cuff Repair Augmentation SystemFile Type: Ref. Systematic reviews of wound care management: (2) dressings and topical agents used in the healing of chronic wounds. To address this, the ReCell Autologous Cell Harvesting Device (ReCell) was designed for use at the point-of-care (POC) to prepare a non-cultured, autologous skin cell suspension (ASCS) capable of epidermal regeneration using minimal donor skin. Br J Nurs. Rockville, MD: AHRQ; December 18, 2012. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2004. Patel MR, Stadler ME, Snyderman CH, et al. Lee K, Goodman SB. Br J Neurosurg. WoundEx membrane allograft consists of dehydrated and decellularized human amniotic membrane that has been processed with proprietary HydraTek technology. Salzberg CA. Surg Endosc. Summary of Safety and Probable Benefit. Available at:http://www.synovissurgical.com/. Effectiveness of Suprathel application in partial thickness burns, frostbites and Lyell syndrome treatment. Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction. There was strong evidence of tissue incorporation and blood vessel infiltration. Complications following decompression of Chiari malformation Type I in children: Dural graft or sealant? 2005;76(10):1768-1777. The marine Omega3 wound matrix for treatment of complicated wounds. J Am Acad Dermatol. This product works as a barrier and covering for acute and chronic non-healing wounds and burn injuries. Muttini A, Barboni B, Valbonetti L, et al. Another potential drawback was the lack of direct comparison to other advanced treatment modalities for diabetic wounds. 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. Int J Burns Trauma. Venous leg ulcers. After 16 weeks of treatment, patients in each group were evaluated on 4 criteria: O'Donnell and Lau (2006) examined if more "modern" complex wound dressings further improve the healing of venous ulcers over that with simple wound dressings. Available at: http://www.microvas.com/surgerymag.html. 04/26/2023 Efficacy of fibrin sealant (human) (Evicel) in rhinoplasty:A prospective, randomized, single-blind trial of the use of fibrin sealant in lateral osteotomy. Cygnus Matrix is a multilayer allograft derived from the amnion and chorion layers of the This device is intended to achieve epidermal regeneration and definitive wound with reduction in skin donor use. Barber FA, Burns JP, Deutsch A, et al. Inferolateral AlloDerm hammock for implant coverage in breast reconstruction. 2016;104(7):1495-1503. 2009;22(1):20-24. Lecheminant J, Field C. Porcine urinary bladder matrix:A retrospective study and establishment of protocol. These injuries can result in inflammation, reduced mobility, and chronic pain. Colorectal Dis. Lantis JC, II, Lullove EJ, Liden B, et al. Sonnad SS, Goldsack J, Mohr P, Whicher D. Methodological recommendations for comparative effectiveness research on the treatment of chronic wounds. Suprathel-acetic acid matrix versus acticoat and aquacel as an antiseptic dressing: An in vitro study. Clin Orthop Relat Res. Revita (StimLabs, LLC.) 2014;23(3):409-419. Experience with porcine acellular dermal collagen implant in one-stage tension-free reconstruction of acute and chronic abdominal wall defects. J Am Podiatr Med Assoc. Salgado W Jr, Rosa GV, Nonino-Borges CB, Ceneviva R. Prospective and randomized comparison of two techniques of staple line reinforcement during open Roux-en-Y gastric bypass: Oversewing and bioabsorbable Seamguard. Rathinam S, Naidu BV, Nanjaiah P, et al. Gillam AJ, Da Camara CC. Gordley K, Cole P, Hicks J, Hollier L. A comparative, long term assessment of soft tissue substitutes: AlloDerm, Enduragen, and Dermamatrix. The manufacturers Web site does not specifically state if Puros Dermis is derived from human tissue, although this may be implied. Antibiotic ointment versus a silver-based dressing for children with extremity burns: A randomized controlled study. 2018;22(4):e2018.00057. Attachment# 16.055 . A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. Oasis Burn Matrix: HCPCS codes not covered for indications listed in the CPB: Q4103: Oasis Burn Matrix, per sq cm : ICD-10 codes not covered for indications listed in the CPB (not all inclusive): T20.011A - T25.799S: Burns: ParietexComposite (PCO) Mesh: HCPCS codes not covered for the indications listed in the CPB: C1781: Mesh (implantable) 2022;75:103446. 2017;26(12):2158-2166. Ann Med Surg (Lond). A benefit of selecting the 644 affiliated centers is that it ensures consistency in reporting as well as the clinical practice. Johnson EL, Marshall JT, Michael GM. 2014;16(3):192-197. Bluebond-Langner R, Keifa ES, Mithani S, et al. Additionally, the biodegradable collagen matrix functions as a scaffold for cellular and capillary in-growth. Bowers CA, Brimley C, Cole C, et al. Arthrex Amnion matrix is rich in growth factors and contains regenerative qualities that maintain the natural healing properties of amnion. #: 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. In: BMJ Clinical Evidence. Diabetes Care. Acta Neurochir (Wien). Acta Neurochir (Wien). User corrected segmentations are then propagated to neighboring time points. Narotam PK, Jose S, Nathoo N, et al. Apligraf for burn injuries. 2012;19(3):325-330. Cymetra. World J Pediatr Congenit Heart Surg. It is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Am Surg. The role of Apligraf in the treatment of venous leg ulcers. When hospitals or physicians use an item that does not have a HCPCS Level II code, they should build the cost for the item Dis Colon Rectum. Subjects included adults with diabetic foot ulcers one month or more in duration. Champagne BJ. Clin Infect Dis. Br J Surg. Case report. London, UK: NICE; January 2018. 2023;315(1):17-31. Thompson P, Hanson DS, Langemo D, Anderson J. Center for Medicare and Medicaid Services (CMS). The authors concluded that the findings of this study showed that the use of ASCS + compression accelerated healing in large VLUs. Arthrosc Tech. Jensen KK, Rashid L, Pilsgaard B,et al. TissueMend soft tissue repair matrix. 1993;11(9):387-392. The HAM group was associated with less pruritis, dressing changes, and discomfort than the non-HAM group. abdominal and thoracic wall repair, muscle flap reinforcement, rectal and vaginal prolapse repair, urinary incontinence treatment, reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). Ann Plast Surg 2014;73(3):282-285. Patients were advised not to use any compression system during the study. 2005;26(4):344-347. 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. Efficacy of autologous platelet-rich plasma use for orthopaedic indications:A meta-analysis. The enrolled patients met the following criteria: age greater than 18 years with mixed arterial/venous leg ulcer by clinical and instrumental assessment, venous reflux by Doppler flow studies, ankle brachial pressure index greater than 0.6 and less than 0.8, ulcer duration greater than 6 weeks and size 2.5to 10 cm(2), and 50 % or more granulation tissue on the wound bed.