Cochrane Database Syst Rev. Weindl G, Schaller M, Schfer-Korting M, et al. AGENDA ITEM #1 1 . Eur J Plast Surg. Use of an acellular flowable dermal replacement scaffold on lower extremity sinus tract wounds: A retrospective series. 2012;23(12):1797-1799. Clinical Guidelines for Type 2 Diabetes: Prevention and Management of Foot Problems [Internet]. Lavery LA, Killeen AL, Farrar D. The effect of continuous diffusion of oxygen treatment on cytokines, perfusion, bacterial load, and healing in patients with diabetic foot ulcers. Wounds. Mepitel Ag (hazard ratio [HR] 0.57 (95 % confidence interval [CI]: 0.40 to 0.82); p = 0.002) significantly reduced the rate of wound healing, adjusting for burn thickness and fungal wound infection. Plast Reconstr Surg. U.S. Food and Drug Administration (FDA). No infections were noted nor was there a discernible impact on metabolism; animal growth and development subsequent to implantation were normal. Barber FA, Herbert MA, Boothby MH. Cook JB, Shaha JS, Rowles DJ,et al. Implant Dent. Characterization of a cryopreserved split-thickness human skin allograft - TheraSkin. 2013;40(4):403-408. He C, Hughes MA, Cherry GW, Arnold F. Effects of chronic wound fluid on the bioactivity of platelet-derived growth factor in serum-free medium and its direct effect on fibroblast growth. Gravante G, Di Fede MC, Araco A, et al. Evaluation of porcine dermal collagen (Permacol) used in abdominal wall reconstruction. J Pediatr Surg. Transplantation of chronic wounds with epidermal sheets derived from autologous hair follicles--the Leipzig experience. Derwin KA, Baker AR, Spragg RK, et al.Commercial extracellular matrix scaffolds for rotator cuff tendon repair. Horizon Scanning Prioritising Summary. 2011;6(4):364-372. J Hand Surg Am. Am J Otolaryngol. Micronized, particulate dermal matrix to manage a non-healing pressure ulcer with undermined wound edges: A case report. Centers for Medicare & Medicaid Services (CMS). Trends Biotechnol. Health Tech Assess. "WoundEx Thin Membrane is designed as a single layer wound covering for common wounds, and WoundEx Thick Membrane is designed as a thicker single layer wound covering, for deeper wounds where more tissue bulk is required." A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Hu S, Kirsner RS, Falanga V, et al. 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. J Neurosurg. Report No. 2002;28(1):81-82. 1991;213(4):292-296. A higher proportion of wounds in the treatment group compared with the controls were more likely to close (68.3 % versus 60.3 %), particularly wounds with exposed structures (64 % versus 50.4 %) and with lower recidivism at 6 months (24.9 % versus 28.3 %). The authors concluded that skin substitute usage in MMS reconstruction is not well-guided. 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. sizes. Jiang WG, Harding KG. Human reticular acellular dermal matrix in the healing of chronic diabetic foot ulcerations that failed standard conservative treatment: A retrospective crossover study. Treatment of genital prolapse by hammock using porcine skin collagen implant (Pelvicol). 2011;37(7):e67-e72. 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. 2012;99(10):1381-1388. Plast Reconstr Surg Glob Open. 2014;23(7):355-357. Clin Plast Surg. Franklin ME Jr, Trevino JM, Portillo G,et al. Use of regenerative human acellular tissue (AlloDerm) to reconstruct the abdominal wall following pedicle TRAM flap breast reconstruction surgery. Healthcare Common Procedure Coding System (HCPCS). Additionally, these patients had to have not demonstrated a 50% reduction in would area following 4 weeks of standard treatment for inclusion in this study. Use of human acellular dermal matrix in complex and contaminated abdominal wall reconstructions. 2011;21(7):579-582. Wajon A, Vinycomb T, Carr E, et al. Diabetes Care. 510(k) Summary. Ann Plast Surg. 2019;8(5):e465-e472. 2008;51(5):263-266. Genital prolapse repair with Avaulta Plus() mesh: Functional results and quality of life. #: OF1-000331-en-USVersion: FLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for the Eclipse Total Shoulder SystemFile Type: Ref. Clarke S, Hagberg W, Kaufmann RA,et al. Cassidy C, St Peter SD, Lacey S, et al. A comparison of gastrojejunal anastomoses with or without buttressing in a porcine model. Hsu PW, Salgado CJ, Kent K, et al. Successful treatment of a patient with an extraordinarily large deep burn. 2014;156(4):902-908. Colorectal Dis. Vas P, Rayman G, Dhatariya K, et al. LifeCell also produces Repliform, which seems to be the same product as AlloDerm (Snyder, et al., 2012). Single-institution outcome experience using AlloDerm as temporary coverage or definitive reconstruction for cutaneous and soft tissue malignancy defects. Bindingnavele V, Gaon M, Ota KS, et al. Foreign material erosion after laparoscopic Roux-en-Y gastric bypass: Findings and treatment. Stammberger U, Klepetko W, Stamatis G,et al. De Angelis N, Felice P, Pellegrino G,et al. Dressings for healing venous leg ulcers. Furthermore, Symphonys design scaffolds the patients own cells to rebuild dermal tissues in acute and chronic wounds. Bullard D, Souza J. Three-level anterior cervical discectomy and fusion with plate fixation: Radiographic results of 127 patients. 2001;24(2):290-295. Bradley M, Cullum N, Nelson EA, et al. Int J Shoulder Surg. #: OF1-000180-en-USVersion: GLanguage: EnglishRevision Date: 01/03/2023 2023 Coding and Reimbursement Guidelines for the FiberTak AnchorsFile Type: Ref. Int Urogynecol J. 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. SurgiMend Collagen Matrix (TEI Biosciences, Boston, MA) was cleared through the FDA 510(k) process in 2007. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Zelen CM. 2005;18(5 Pt 1):258-266. 2011;66(5):424-428. Treatment of a patient with small fiber pathology using nerve biopsy and grafting:A case report. J Neurosurg. The proprietary process of recovering Pro3-Cord and Pro3-Placenta preserves the natural healing properties to facilitate regenerative healing as opposed to scar-mediated healing. Incidence and management of vaginal extrusion of acellular porcine dermis after incontinence and prolapse surgery. Stern R, McPherson M, Longaker MT. Spine J. Newport News, VA: Soluble Systems; revised August 10, 2011. Outcome of large to massive rotator cuff tears repaired with and without extracellular matrix augmentation: A prospective comparative study. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Appl Health Econ Health Policy. In an animal model, ProLayer Acellular Dermal Matrix (ADM) was implanted into 12 rats. Emerging Device List No. To get a Q-code, you submit a description for your product and state why it's like another product that Medicare reimburses. Biomed Res Int. 2006;60(1):17-22. Dermatology. These researchers compared fusion success rates and pseudarthrosis results with published data for 3-level anterior cervical constructs including; anterior cervical discectomy and fusion with plating (ACDFP) and anterior cervical corpectomy with and without plating (ACCP, ACC). Center for Medicare and Medicaid Services (CMS). www.arthrex.com Or you may have to look it up not by trade name but extracellular matrix instead. Centers for Medicare & Medicaid Services (CMS). There were 778 patients treated with the graft in the treatment cohort, who were paired with 778 patients drawn from a pool of 126,864 candidates treated with SOC alone (controls), by using propensity matching to create nearly identical cohorts. Eaglstein WH, Falanga V. Tissue engineering and the development of Apligraf, a human skin equivalent. Carter MJ, Fylling CP, Li WW,et al. Srivastava A, Maniakas A, Myers J, et al. Am J Orthop (Belle Mead NJ). 510(k) Summary. Newton DJ, Khan F, Belch JJ, et al. 2012;14(5):e264-e269. J Am Podiatr Med Assoc. Patients were treated under anesthesia or moderate sedation. Strattice is used by surgeons as a surgically implanted soft tissue patch to reinforce a patient's soft tissue where weakness exists, and for the surgical repair of damaged or ruptured soft tissue, such as in hernia repair, open abdominal repairs and in breast reconstruction, post mastectomy. Acta Orthop. Arch Dermatol Res. Sanchez AR, Sheridan PJ, Kupp LI. Surgraft is supplied in five sizes: 2 x 2 cm, 2 x 3, 2 x 4 cm and 4 x 8 cm. 13. AlloPatch Pliableallograft dermal matrix. Hubik DJ, Wasiak J, Paul E, Cleland H. Biobrane:A retrospective analysis of outcomes at a specialist adult burns centre. Massee M, Chinn K, Lei J, et al. This nerve is of greatest concern when repairing a midsubstance Achilles tendon rupture. Ann Plast Surg. 2009;36(3):179-181. Implant breast reconstruction using acellular dermal matrix. Sprague-Dawley rats were anesthetized and prepped for surgery; 4 1.5-cm diameter full-thickness wounds were created and treated with either: Sultan et al (2018) evaluated the use of placental and amniotic tissue-based products as an adjuvant treatment to the operative management of orthopedic sports injuries. TheraGenesis is intended for the treatment of patients with chronic and traumatic wounds including but not limited to diabetic foot ulcers, venous leg ulcers, burns, and other chronic and traumatic wounds and tissue deficits. Thomin A, Touboul C, Hequet D, et al. Gefasschirurgie. Pediatr Neurosurg. 2013;23(1):e38-e40. The effect of platelet-rich plasma on the coronally advanced flap root coverage procedure: A pilot human trial. Trials are needed to determine clinical and cost-effectiveness and long-term outcomes including adverse events.". Case report. Surg Endosc. Satterwhite TS, Miri S, Chung C,et al. A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients. Discovery and development of avotermin (recombinant human transforming growth factor beta 3):A new class of prophylactic therapeutic for the improvement of scarring. Unite Biomatrix is a non-reconstituted collagen dressing used to maintain the wound bed in the healing phase thereby allowing for health granulation tissue and wound closure. 95-0652. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS). 2010;20(6):397-404. In Vitro Cell Dev Biol Anim. (2015) examined planned interim data of a prospective, randomized, double-blind multi-center study comparing the clinical efficacy of the TransCu O2 device (EO2 Concepts) to standard moist wound therapy (MWT). For additional language assistance: Debridement of premalignant hyperkeratotic lesion(s) (ie, targeted curettage, abrasion) followed with photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified health care, Application of low cost skin substitute graft to trunk, arms, legs, Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, Debridement, bone including epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed, first 20 sq cm or less with manual preparation and insertion of deep (eg, subfacial) drug-delivery device(s), bone, each additional 20 sq cm, or part thereof, Surgical preparation or creation of recipient site, Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (eg, breast, trunk) (List separately in addition to code for primary procedure), Debridement (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized epidermis and/or dermis, exudate, devris, biofilm), including topical application(s), wound assessment, use of a whirlpool, when performed and instructions (s) for ongoing care, per session, total wound(s) surface area; first 20 sq cm or less, each additional 20 sq cm, or part thereof (List separately in addition to code for primary procedure), Diabetes mellitus due to underlying condition with foot ulcer, Drug or chemical induced diabetes mellitus with foot ulcer, Other specified diabetes mellitus with foot ulcer, Varicose veins of lower extremities with ulcer, Varicose veins of lower extremities with ulcer and inflammation, Chronic venous hypertension (idiopathic) with ulcer, Chronic venous hypertension (idiopathic) with ulcer and inflammation, Streptococcus, staphylococcus, enterococcus and other bacterial agents as the cause of diseases classified elsewhere, Other and unspecified local infections of skin and subcutaneous tissue, Open wounds [Codes not listed due to expanded specificity], Atherosclerosis of the extremities with gangrene, Other and unspecified local infection of skin and subcutaneous tissue, Integra Dermal Regeneration Template (DRT), per sq cm, Skin substitute, Integra Meshed Bilayer Wound Matrix, per square centimeter, Integra Bilayer Matrix Wound Dressing (BMWD), per sq sm, Reconstruction of complete shoulder (rotator) cuff avulsion, chronic (includes acromioplasty), Revision of total shoulder arthroplasty, including allograft when performed, Reconstruction lateral collateral ligament, elbow, with tendon graft (includes harvesting of graft), Repair medical collateral ligament, elbow, with local tissue, Reconstruction medial collateral ligament, elbow, with tendon graft (includes harvesting of graft), Revision of total elbow arthroplasty, including allograft when performed, Capsulorrhaphy or reconstruction, wrist, open (eg, capsulodesis, ligament repair, tendon transfer or graft) (includes synovectomy, capsulotomy and open reduction) for carpal instability, Reconstruction for stabilization of unstable distal ulna or distal radioulnar joint, secondary by soft tissue stabilization (eg, tendon transfer, tendon graft or weave, or tenodesis) with or without open reduction of distal, Arthroplasty, with prosthetic replacement; distal radius and distal ulna, Arthroplasty, with prosthetic replacement; distal radius and partial or entire carpus (total wrist), Synovectomy, metacarpophalangeal joint including intrinsic release and extensor hood reconstruction, each digit, Synovectomy, proximal interphalangeal joint, including extensor reconstruction, each interphalangeal joint, Excision flexor tendon, with implantation of synthetic rod for delayed tendon graft, hand or finger, each rod, Reconstruction of tendon pulley, each tendon, Reconstruction, collateral ligament, metacarpophalangeal joint, single, Reconstruction, collateral ligament, interphalangeal joint, single, including graft, each joint, Repair and reconstruction, finger, volar plate, interphalangeal joint, Transfer, toe-to-hand with microvascular anastomosis, Transfer, finger to another position without microvascular anastomosis, Transfer, free toe joint, with microvascular anastomosis, Reconstruction of polydactylous digit, soft tissue and bone, Cervical lymphadenectomy (modified radical neck dissection), Excision of parotid tumor or parotid gland, Other congenital malformations of skull and face bones, Congenital malformation of skull and face bones, unspecified, Genetic susceptibility to malignant neoplasm of breast, Genetic susceptibility to malignant neoplasm of ovary, Family history of malignant neoplasm of breast, Family history of malignant neoplasm of ovary, Personal history of malignant neoplasm of breast, Squamous cell carcinoma of skin of scalp and neck, Rectal fistula [trans-sphincteric rectal fistula], Secondary focal hyperhidrosis [Frey's syndrome], Human plasma fibrin sealant, vapor-heated, solvent-detergent (Artiss), 2ml, Type II diabetes mellitus with foot ulcer, Chronic venous hypertension with ulcer and inflammation, E08.621, E09.621, E10.621, E11.621, E13.621, Other specified disorders of nose and nasal sinuses [oro-nasal fistula], Personal history of (corrected) cleft lip and palate [oro-nasal fistula], Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, T20.311A- T20.39XS, T20.711A T20.79XS, Burn and corrosion of third degree of face, head, and neck, T21.30XA T21.39XS, T21.70XA T21.79XS, Burn and corrosion of third degree of trunk, T22.301A T22.399A, T22.711A T22.799S, Burn and corrosion of third degree of shoulder and upper limb, T23.301A T23.399S, T23.701A T23.799S, Burn and corrosion of third degree of wrist and hand, T24.301A T24.399S, T24.701A - T24.799S, Burn and corrosion of third degree of lower limb, except ankle and foot, T25.311A T25.399S, T25.711A T25.799S, Burn and corrosion of third degree of ankle and foot, Burn [any degree] 30 to 90 percent or more of body surface, Non-pressure chronic ulcer of lower limb, not elsewhere classified, E08.621, E09.621, E10.621, E11.621, E13.621, DermACELL, DermACELL AWM or DermACELL AWM Porous, per sq cm, Personal history of (corrected) cleft lip and palate, FlexHD, AllopatchHD, or Matrix HD, per sq cm, Actigraft, Adherus Dural Sealant, AlloAid amniotic liquid / amniotic patch, AlloMax, AlloSource cryopreserved human cadaver skin, Amnio FRT, AmnyoFactor, AmnioHeal amniotic membrane, Amnion allograft ASG, Cook Medical anal fistula plug, AmnioMTM, AmnioShield, AmnioStrip, Amniox (human embryonic membrane), BioDfactor, BioDRestore Elemental Tissue Matrix, Bionect, Biostat Biologx Fibrin Sealant, PTFE felt, Biotape Reinforcement Matrix, CellECT (human amnion and amniotic fluid allograft), CellerateRX, CollaFix, CollaMend, Connexa reconstruction tissue matrix, CorMatrix Patch, Cortiva Allograft Dermis, C-Qur biosynthetic mesh, CRXa, Cuffpatch, dehydrated human amniotic membrane allograft (e.g., AmnioPro, BioFix), Dermamatrix, DuraGen Plus Dural Regeneration Matrix, DuraMatrix, DuraSeal, Durepair Regeneration Matrix, Endoform, ENDURAgeN, EPIFLO transdermal continuous oxygen therapy, Epiburn, Epidex, FloGraft, Fortiva Porcine Dermis, GORE BIO-A Fistula Plug, Graftjacket regenerative tissue matrix for rotator cuff repair and carpometacarpal (CMC) joint repair, Granufoam silver VAC dressing, HydroFix, Inforce, Jacobs Ladder external closure device, LiquidGen, Matriderm, Matrix PSM, MediHoney, Medeor, Mepitel Ag, Meso BioMatrix, MiAmnion, Neuroflex, NeuroForm Dermis, NuCel liquid wound covering, OrthADAPT Bioimplant (type I collagen scaffold), OrthoFlo, OsseoGuard, Ovation, Pelvico, Pelvisoft, Peri-Guard Repair Patch, Peri-Strips Dry, Peri-Strips Dry with Veritas Collagen Matrix, placental tissue matrix allograft. As the dressing material accumulates fluid, silver ions are released from the dressing into the wound environment. Operative applications of placental tissue matrix in orthopaedic sports injuries: A review of the literature. 2020;17(4):966-973. Use of Seamguard to prevent pancreatic leak following distal pancreatectomy. Koutsougeras G, Nicolaou P, Karamanidis D,et al. Blood flow changes in diabetic foot ulcers treated with dermal replacement therapy. Rommer EA, Peric M, Wong A. Urinary bladder matrix for the treatment of recalcitrant nonhealing radiation wounds. Surgeon. Cytal Burn Matrix is supplied as: 7 cm x 10 cm fenestrated wound sheet, 1 ea; and 7 cm x 10 cm meshed wound sheet, 1 ea. The two products are prescribed by a physician or other qualified health care professional and indicated for the management of wounds. Comparative evaluation of the antimicrobial activity of ACTICOAT antimicrobial barrier dressing. Longinotti C. The use of hyaluronic acid based dressings to treat burns: A review. 2017;224(3):351-361. Humanitarian Device Exemption No. Reinforcing the staple line during laparoscopic sleeve gastrectomy: Prospective randomized clinical study comparing two different techniques. Alvarez OM, Smith T, Gilbert TW, et al. Int Wound J. Surgery. American Burn Association. 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. U.S. Food and Drug Administration (FDA). Burns. DiDomenico LA, Orgill DP, Galiano RD, et al. Burns. Ananian CE, Dhillon YS, Van Gils CC, et al. One study for each of 3 targeted AWCMs (Apligraf [n = 130 treatment, n = 110 control]; Oasis Wound Matrix [n = 62 treatment, n = 58 control]; and Talymed [n = 22 treatment, n = 20 control]) met inclusion criteria. Restrata is a wound matrix that is classified as a skin substitute. Osbun JW, Ellenbogen RG, Chesnut RM,et al. Dantzer E, Braye FM. Edmonds M; European and Australian Apligraf Diabetic Foot Ulcer Study Group. Ann Maxillofac Surg. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050355.pdf. Intra-articular injection of micronized dehydrated human amnion/chorion membrane attenuates osteoarthritis development. Bone and tendon coverage via dehydrated human amniotic/chorionic membrane and split-thickness skin grafting. Topical silver for treating infected wounds. Int Wound J. Wasiak J, Cleland H. Burns (minor thermal). Ann Plast Surg. J Obstet Gynaecol. 2018;5(4):329-338. InnovaMatrix AC [website]. 2009;4:37. The use of Hyalomatrix PA in the treatment of deep partial-thickness burns. Gauglitz GG, Williams FN. Trop M, Novak M, Rodl S, et al. National Institute for Health and Clinical Excellence (NICE) Diabetic foot problems: Inpatient management of diabetic foot problems.
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