Reconstruction of pulmonary venous conduit with CorMatrix in lung transplant. Acellular Matrices are the most frequently used skin substitute. J Otolaryngol Head Neck Surg. 1993;27(10):1201-1203. 2009;6(3):226-232. 2005;66(6):1314-1318. de Boer TA, Gietelink DA, Hendriks JC, Vierhout ME. Influence of bioengineered skin substitutes on diabetic foot ulcer and venous leg ulcer outcomes. They are available in 0.5 cc, 1 cc and 2 cc dose sizes. Thoracic wall reconstruction with Collamend in trauma: Report of a case and review of the literature. Steinberg JS, Edmonds M, Hurley DP Jr, King WN. Cygnus Matrix is a multilayer allograft derived from the amnion and chorion layers of the Clinical and cost efficacy of advanced wound care matrices for venous ulcers. A discussion of CHAMPUS policy. "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." Plast Reconstr Surg. Immediate single-stage reconstruction of the breast utilizing FlexHD and implant following skin-sparing mastectomy. Holmes et al (2019) stated that STSG are the SOC for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. Brinster DR, Patel JA. This was a single case study on the use . #: OF1-000180-en-USVersion: GLanguage: EnglishRevision Date: 01/03/2023 2023 Coding and Reimbursement Guidelines for the FiberTak AnchorsFile Type: Ref. Hayes et al (2020) stated that venous leg ulcers (VLUs) have a significant impact on approximately 3 % of the adult population worldwide, with a mean NHS wound care cost of 7,600 per VLU over 12 months. Agrawal H, Tholpady S, Capito A, et al. 2012;16(3):201-6. doi: Christoforidis D, Etzioni DA, Goldberg SM,et al. Comparison of staple-line leakage and hemorrhage in patients undergoing laparoscopic sleeve gastrectomy with or without Seamguard. 2012;130(5 Suppl 2):256S-269S. Int Rev Modern Surg, February 2002. Treadwell T. A prospective comparison of diabetic foot ulcers treated with either cryopreserved skin allograft or bioengineered skin substitute. Bullocks JM. Surg Endosc. J Tissue Eng Regen Med. These investigators recruited all patients with deep partial thickness burns admitted at the Burn Centre of S. Eugenio Hospital in Rome over 2 years. Chalmers RT, Darling Iii RC, Wingard JT,et al. 1996;17(2):124-136. Dis Colon Rectum. Longaker MT, Chiu ES, Harrison MR, et al. The Provant Wound Closure System (Regenesis was cleared by the FDA as a wound healing device based on a 510(k) premarket notification. 2015;4(6):e751e755. Towler et al (2018) noted that chronic venous leg ulcers (VLUs) are responsible for significant morbidity and health care costs worldwide. Arthroscopy. Fewer dressing changes and easier overall management of the wounds contribute to its favorable profile. Transfus Apher Sci. UpToDate [serial online]. EpiDex Swiss field trial 2004-2008. Interaction between a regenerative matrix and wound bed in nonhealing ulcers: Results with 16 cases. 2005;26(4):344-347. 2022;19(3):470-481. 2019b;16(1):122-130. Biomed Res Int. Beitzel K, McCarthy MB, Cote MP,et al. J Wound Care. Comparative study between biologic porcine dermal meshes: Risk factors of postoperative morbidity and recurrence. 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. Lorenz RR, Dean RL, Hurley DB, et al. TissueMend for the repair or reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons, and all other indications. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2013. Gillam AJ, Da Camara CC. 2007. Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review. Guidance on the use of debriding agents and specialist wound care clinics for difficult to heal surgical wounds. Rockville, MD: FDA; December 6, 2006. Laryngoscope. J Manag Care Pharm. Clin Podiatr Med Surg. Ann Plast Surg 2014;73(3):282-285. J Cardiothorac Surg. #: DOC1-000542-en-USVersion: FLanguage: EnglishRevision Date: 02/23/2023 2023 Coding and Reimbursement Guidelines for the SpeedBridge TechniqueFile Type: Ref. 4.9x More Total Living Cells than claimed by Dermagraft. 2013;27(10):3654-3662. Key variables were reported at 60, 90, and 180 days after the 1st product application. BJOG. Int Wound J. These researchers had little direct insight to the level of compliance provided by study participants. These researchers stated that more studies with larger patient population are needed to examine the effectiveness of this therapy in chronic wound healing, and its potential to be used as an alternative to HBOT. J Thorac Cardiovasc Surg. Decellularization of human dermis using non-denaturing anionic detergent and endonuclease: A review. SurFactor and NuDyn are intended for topical application to the wound surface, to irrigate a wound bed and/or injected directly into the site of the lesion, wound margins or in surrounding tissue near the inflammation. 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. 2013;4:26. J Shoulder Elbow Surg. Burns. -peroneal. Niederauer MQ, Michalek JE, Armstrong DG. Newport News, VA: Soluble Systems; revised April 22, 2011. 2012;(10):CD006899. Internal Clinical Guidelines Team. 2010;221(4):365-372. Restorigin Amnion Patch (Parametrics Medical) is derived from the amnion layer of fetal membranes in the umbilical cord. Zelen CM, Serena TE, Fetterolf DE. #: 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. Mil Med. 2011;37(2):294-298. J Oral Maxillofac Surg. Integra LifeSciences Corp, Plainsboro, NJ. Suprathel() causes less bleeding and scarring than Mepilex() Transfer in the treatment of donor sites of split-thickness skin grafts. 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. Summary of safety and effectiveness RECELL Autologous Cell Harvesting Device. Baltimore, MD: Center for Medical Technology Policy (CMTP); October 12, 2012. 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. A clinical experience. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. PDF Cigna Medical Coverage Policy - AAPC The wound bed was prepared by using either rough debridement or dermabrasion excision. 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. 2018;15(1):114-122. 2013;103(4):274-280. 2013;29(4):223-232. Kimmel H, Rahn M, Gilbert TW. Johnson W, Inamasu J, Yantzer B,et al. Injury. 2009;34(6):1029-1036. Wiechula R. Post harvest management of split thickness skin graft donor sites:A systematic review. Evaluation of a transvaginal mesh delivery system for the correction of pelvic organ prolapse: Subjective and objective findings at least 1 year after surgery. Scott BG, Welsh FJ, Pham HQ, et al. Stability is pleased to announce that our request for a Level II HCPCS code for AmnioCore Amniotic Membrane Allograft has been established . 2002;41(4):233-237. Mihata T, Lee TQ, Watanabe C, et al. Lipsky BA, Berendt AR, Cornia PB, et al. 1998;134(3):293-300. Niederauer MQ, Michalek JE, Liu Q, et al. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Moseley R, Walker M, Waddington RJ, Chen WY. 2015;18(8):586-595. Int Wound J. Wong I, Burns J, Snyder S. Arthroscopic GraftJacket repair of rotator cuff tears. 2004;29(24):2861-2867; discussion 2868-2869. The authors concluded that the findings of this study suggested that TheraSkin may provide equivalent or superior outcomes to Apligraf while reducing costs. These investigators noted that the ReCell procedure was generally well-tolerated, even in the immediate post-operative period. Meyer RA, Bagheri SC. Franklin ME Jr, Trevino JM, Portillo G,et al. According to the requester, this product has a significant therapeutic distinction over similar products in that it offers the following characteristics: As noted by the authors, limitations of this study included: Bakri and colleagues (2008) tested the hypothesis that local transdermal delivery of oxygen improves oxygenation in sternotomy wounds after cardiac surgery; the secondary hypothesis was that supplemental inspired oxygen improves sternal wound PsqO(2). Wounds. Neurosurgery. Clinical Guidelines for Type 2 Diabetes: Prevention and Management of Foot Problems [Internet]. Glat P, Orgill DP, Galiano R, et al. Pelvic, abdominal, and chest wall reconstruction with AlloDerm in patients at increased risk for mesh-related complications. Markl P, Prantl L, Schreml S, Babilas P,et al. Chest wall resection and reconstruction for locally advanced primary breast cancer. Patel KM, Albino FP, Nahabedian MY, Bhanot P. Critical analysis of Strattice performance in complex abdominal wall reconstruction: Intermediate-risk patients and early complications. A randomized, investigator-blinded, controlled pilot study to evaluate the safety and efficacy of a poly-N-acetyl glucosamine-derived membrane material in patients with venous leg ulcers. 2014;27(1):20-25. Dehydrated amniotic membrane allografts for the treatment of chronic wounds: A case series. Taylor GB, Moore RD, Miklos JR, Mattox TF. 2011;36(1):157-169. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. Gabriel A, Gollin G. Management of complicated gastroschisis with porcine small intestinal submucosa and negative pressure wound therapy. Arch Dermatol Res. Wounds. J Oral Maxillofac Surg. 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. Wound Repair Regen. Booth JH, Garvey PB, Baumann DP, et al. 2012;10(1):16-19. 2009;144(10):894-899. 2011;90(12):1393-1401. 510(k) Summary. Hernia repair with porcine small-intestinal submucosa. REGUaRD contains extracellular matrix (ECM) that provides a scaffold for cellular ingrowth vascularization, tissue regeneration and formation of granulation tissue. Erbatur S, Coban YK, Aydn EN. Ryan CM, Schoenfeld DA, Malloy M, et al. 2007;28(2):269-274. Levy D, Banta MR, Kirsner RS. 2014;24(7):1109-1116. Serena TE, Carter MJ, Le LT,et al. A total of 32 (65.3 %) index wounds were completely healed at 6 months, including 16 of 24 (66.7 %) in the spray-on skin group and 16 of 25 (64.0 %) in the SOC group (unadjusted OR [95 % CI]: 1.13 (0.35 to 3.65), p = 0.845). J Vasc Nurs. Bano F, Barrington JW, Dyer R. Comparison between porcine dermal implant (Permacol) and silicone injection (Macroplastique) for urodynamic stress incontinence. WoundEx membrane allograft consists of dehydrated and decellularized human amniotic membrane that has been processed with proprietary HydraTek technology. Human reticular acellular dermal matrix in the healing of chronic diabetic foot ulcerations that failed standard conservative treatment: A retrospective crossover study. DeCarbo WT. The device was intended to be used continuously; however, there were inevitably times the device came off while the patient was sleeping or during the day, and because all of our study subjects had severe diabetic sensory neuropathy, the problem was often not identified immediately. Denard PJ, Brady PC, Adams CR, et al. Br J Nurs. Pro3-C Placenta and Cord. 1,2 1. Br J Community Nurs. Baltimore, MD: CMS; September 30, 2021b. The combination of polytetrafluoroethylene mesh and titanium rib implants: An innovative process for reconstructing large full thickness chest wall defects. Lullove E. A Flowable Placental tissue matrix allograft in lower extremity injuries: A pilot study. Int Wound J. Urology. K081635. 2009;52(9):1578-1583. Foreign material erosion after laparoscopic Roux-en-Y gastric bypass: Findings and treatment. Revitalon can be used as a covering for full-thickness wounds, damaged membranes, and as a dressing for burns. Sivaraj D, Henn D, Fischer KS, et al. Int Wound J. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2004. Zienowicz RJ, Karacaoglu E. Implant-based breast reconstruction with allograft. Rawlani V, Buck DW, Johnson SA, et al. TheraSkin is generally applied like an autograft, insuring that the dressing is in close contact with the wound surface and that shear is minimized. 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. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); 2011. World J Pediatr Congenit Heart Surg. Wilgus TA. 1997;21(11):1203-1210. 2006;38(2):174-187. Abbasian B, Kazemini H, Esmaeili A, Adibi S. Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats. 2014;208(3):480-484; discussion 483-484. J Am Coll Surg. Khodadadi A, Olang O, Makhllough A, et al. J Perinatol. National coverage determination (NCD) for blood derived products for chronic non-healing wounds (270.3). Symbas J, McCord C, Nahai F. Acellular dermal matrix in eyelid surgery. TissueMend (TEI Biosciences Inc., Boston, MA), marketed by Stryker Orthopaedics (Stryker Howmedica Osteonics, Kalamazoo, MI), is a remodelable collagen matrix derived from bovine skin intended for reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. 2009;23(6):1415-1416. 2022a;10(12):e4707. Letter to the editor. J Burn Care Rehabil. REGUaRD is packaged in the following sizes: 2cm X 2cm, 2cm X 4cm, 4cm X 4cm, 4cm X 6 and 4cm X 8cm and stored at ambient temperatures. J Wound Care. Dermatol Surg. Keck M, Selig HF, Lumenta DB,et al. Feasibility and early effectiveness of a custom, hand-made systemic atrioventricular valve using porcine extracellular matrix (CorMatrix) in a 4-month-old infant. Restrata is available in a single use double peel package in a variety of sizes. The use of acellular dermal matrices in two-stage expander/implant reconstruction:A multicenter, blinded, randomized controlled trial. 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). Enhancement of wound tissue expansion and angiogenesis by matrix-embedded fibroblast (dermagraft), a role of hepatocyte growth factor/scatter factor. Thamboo A, Thamboo A, Philpott C,et al. Aesthetic Plast Surg. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction. Orthopedics. J Endourol. Holmes JH, 4th, Molnar JA, Shupp JW, et al. Huss FR, Nyman E, Gustafson CJ,et al. Surg Obes Relat Dis. Stravix is supplied as a cryo-preserved placental tissue packaged in a wide-mouth jar. U.S. Food and Drug Administration (FDA). Hille U, Soergel P, Zardo P,et al. Arthroscopy. Centers for Medicare & Medicaid Services (CMS). Clin Podiatr Med Surg. Sade B, Oya S, Lee JH. Cervigni M, Natale F, La Penna C, et al. Dis Colon Rectum. OMeara S, Cullum N, Majid M, Sheldon T. Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration. 2002;97(5):1212-1216.2: Bowers CA, Brimley C, Cole C,et al. Bond JL, Dopirak RM, Higgins J,et al. Br J Plast Surg. Int Wound J. Static treatment modalities in facial paralysis:A review. Accessed June 30, 2008. Losken A. Hyaluronic acid-stimulating activity distinguishes fetal wound fluid from adult wound fluid. 2012;14(5):e264-e269. Long-term outcomes (>5-year follow-up) with porcine acellular dermal matrix (Permacol) in incisional hernias at risk for infection. First Quarter, 2022 HCPCS Coding Cycle. Abdelfatah MM, Rostambeigi N, Podgaetz E, Sarr MG. 2009;9:115. The efficacy and safety of Grafix() for the treatment of chronic diabetic foot ulcers: Results of a multi-centre, controlled, randomised, blinded, clinical trial. Ease of use, safety, and efficacy of integra bilayer wound matrix in the treatment of diabetic foot ulcers in an outpatient clinical setting:A prospective pilot study. 2007;38 Suppl 5:S39-S45. It is intended to bind and protect teh functionality of growth factors, such as platelet-derived growth factors (PDGR) in hostile proteolytic environments. Each allograft is restricted to homologous use in procedures on a single occasion by a licensed physician or surgeon. Obes Surg. Treatment of severe burn with DermACELL(), an acellular dermal matrix. Procuren: A platelet-derived wound healing formula. Dermal regeneration template (Integra) for deep hand burns. DiDomenico L,Emch KJ, Landsman AR. Occleston NL, O'Kane S, Laverty HG,et al. Am J Sports Med. Williams ML, Holewinski JE. Surgeon-controlled study and meta-analysis comparing FlexHD and AlloDerm in immediate breast reconstruction outcomes. Glasberg SB, D'Amico RA. 2012;78(11):1255-1260. Narotam PK, Jose S, Nathoo N, et al. Prepared by the ECRI Institute Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Contract No. Bioabsorbable synthetic plug in the treatment of anal fistulas. Int Wound J. Ann Thorac Surg. Ravaghi H, Flemming K, Cullum NA, Olyaee Manesh A. Electromagnetic therapy for treating venous leg ulcers. Comparing human amniotic allograft and standard wound care when using total contact casting in the treatment of patients with diabetic foot ulcers. In a prospective, randomized multi-center, pilot study, these researchers examined the safety and effectiveness of ASCS combined with compression therapy compared with standard compression alone (Control) for the treatment of VLUs. The study was also limited by small sample size (n = 15). There is a lack of evidence in the peer-reviewed medical literature to support it's clinical effectiveness. Armstrong, et al. Yeen WC, Faber C, Caldeira C,et al. Rihn JA, Patel R, Makda J,et al. Dural augmentation: Part I-evaluation of collagen matrix allografts for dural defect after craniotomy. Fagotti L, Soares E, Bolia IK, et al. Wounds. #: OF1-000331-en-USVersion: FLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for the Eclipse Total Shoulder SystemFile Type: Ref. Dermagraft in the treatment of diabetic foot ulcers. 2007;17(5):365-368. In Vivo. Burns. Topol BM, Dalton EF, Ponn T, et al. Arthroscopy. The prescribed dosage depends on the size of the wound, injury and/or scope of the treatment. Yu S, Jastrow K, Clapp B,et al. Fitchburg, WI: Imbed Biosciences; 2022. JSLS. Enrollment was carried out with a controlled strategy--sampling chart--that allowed homogeneous groups (ReCell and skin grafting) for age, gender, type of burns and TBSA. Case report and review of the literature. 2012;21(10):476, 478-80, 482. Than KD, Wang AC, Etame AB,et al. The epithelial layer is facing the camera and will be wrapped around the anterior cruciate ligament allograft with this layer touching the graft. SureDerm is supplied as 0.25-0.59mm, 0.6-0.99mm, 1.0-1.39mm, 1.4-1.79mm and 1.8mm and over. J Oral Maxillofac Surg. Ann Plastic Surg. Permacol Surgical Implant T-piece and Permacol Surgical Implant Rectocele-piece. Perfusion was measured with hyperspectral imaging and transcutaneous oxygen. Hernia. Diagnoses or procedures may be subject to coding error, for which the extent of miscoding or under-coding that could result in bias is unknown, and may also result in measurement error in ICD-9/10 or CPT based variables. 2011;156(2):217-222. Tokish JM, Beicker C. Superior capsule reconstruction technique using an acellular dermal allograft. 2018;34(6):1764-1773. 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. Fusion was identified by the absence of abnormal motion of the fused segments on flexion / extension lateral radiographs and the presence of continuous trabecular bone formation at the graft / endplate junction. 1993;25(6):535-538. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Tissue-engineered skin. The role of Apligraf in the treatment of venous leg ulcers. An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. Reinforcing the staple line during laparoscopic sleeve gastrectomy: Prospective randomized clinical study comparing two different techniques. J Wound Care. Howard MA, Asmis R, Evans KK, Mustoe TA. This product requires topical application and is held in place with usual attachment and sterile dressings. Guiding practice improvements in pediatric surgery using multidisciplinary clinical pathways. Lu and Khachemoune (2023) stated that the data on skin substitute usage for managing Mohs micrographic surgery (MMS) wounds remain limited. Evaluation of AlloMax acellular dermal matrix for objective collagen deposition. Langer A, Rogowski W. Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers. These components in combination with a single layer of HA provide a conducive environment that is critical to the wound healing process. Rockville, MD: AHRQ; 2003. It comes in a single size configuration as a hexagon patch with 2.5 cm sides, 5.0 cm in diameter, and total surface area of 16 cm squared. Microsurgery. The primary outcome was time to wound healing and p-value of < 0.05 was considered significant. 2011;23(7):190-191. Musculoskeletal Transplant Foundation (MTF). Application Summaries and Coding Recommendations. Coding Reference Guide AmnioRepair Allograft is a lyophilized placental membrane allograft that is aseptically processed to preserve the native extracellular matrix and endogenous proteins. 2004;30(2):145-151. de Leon JM, Driver VR, Fylling CP,et al. 2010;29(7):893-897. Waltham, MA: UpToDate;reviewed November 2013. The fluid tissue combination contains collagens, growth factors, and other key biologic components. Management of split-thickness donor sites with synthetic wound dressings: Results of a comparative clinical study. Armellino MF, De Stefano G, Scardi F, et al. Rockville, MD: FDA; October 10, 2007. London, UK: NICE; June 2008. Stilwell and Delaney (2022a) noted that dermal acellular matrices may be used to replace or repair integumental soft tissues compromised by disease, injury or surgical procedures. Patel KM, Nahabedian MY, Gatti M, Bhanot P. Indications and outcomes following complex abdominal reconstruction with component separation combined with porcine acellular dermal matrix reinforcement. Gariboldi S, Palazzo M, Zanobbio L, et al. AmnioRepair is indicated for use as a biological barrier or wound cover. StrataGraft is a bioengineered, allogeneic, cellularized scaffold product. VIM human amniotic membrane allograft originates from human tissue and is for homologous use. O'Meara S, Martyn-St James M. Foam dressings for venous leg ulcers. Each nerve construct was mounted in a servo-hydraulic materials testing machine and stretched at a constant 5 mm/min displacement rate until failure.
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