Lattari V, Jones LM, Varcelotti JR, et al. Acellular Matrices are the most frequently used skin substitute. Regulski M, Jacobstein DA, Petranto RD,et al. Use of Biobrane to dress split-thickness skin graft adjacent to skin graft donor sites or partial-thickness burns. Cochrane DatabaseSyst Rev. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Q4185 Cellesta flowable amnion (25 mg per cc); per 0.5 cc (New Code Effective 1/1/2019) 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 Standard treatment principles with adjunctive cadaveric allograft application were performed on all wounds in the study. J Hip Preserv Surg. A current review. A clinical evaluation of Biobrane() and Suprathel() in acute burns and reconstructive surgery. Accessed June 30, 2008. Shah SS, Todkar JS, Shah PS. The most favorable estimates of product efficacy (i.e., those that were statistically significant compared with compression therapy) were used. Acellular nerve allografts in peripheral nerve regeneration: A comparative study. All of them received adequate epidermal replacement; however, skin grafting was faster than the ReCell system (p < 0.05). Implantation of a porcine acellular dermal graft in a primate model of rotator cuff repair. Available at: http://www.nice.org.uk/nicemedia/live/11989/52429/52429.pdf. Muttini A, Barboni B, Valbonetti L, et al. 2006;192(6):705-709. J Vasc Surg. Krishnamoorthy L, Harding K, Griffiths D, et al. The high failure rate of biologic resurfacing of the glenoid in young patients with glenohumeral arthritis. Pittsburgh, PA: Promethean LifeSciences; 2008. 2016;16:229. Gutierrez-Moreno S, Alsina-Gibert M, Sampietro-Colom L, et al. Dis Colon Rectum. Dis Colon Rectum. Surg Innov. 2007;33(2):221-229. Comparison study of acellular dermal matrices in complicated hernia surgery. Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. Wounds. Clarke S, Hagberg W, Kaufmann RA,et al. There was no statistical difference for the peak load at failure between any of the groups. Snyder DL, Sullivan N, Schoelles KM. Available in a variety of syringe volume sizes. Dire consequences of the indiscriminate use of Teflon felt pledgets. 2007;21(7):1216-1220. Niederauer MQ, Michalek JE, Liu Q, et al. Stepney, Australia: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S); August 2006. Podiatry Today. Ann Plast Surg. Reda F, Kjartansson H, Jeffery SLA. Technology Assessment Report. The FDA generally permits products regulated solely as human tissue to be commercially distributed without premarket clearance or approval. Additionally, Vende is a structural tissue allograft that is utilized as a skin substituteserving as a protective barrier via resorption into the wound and repairs superficial dermal and soft tissue wounds. Smart NJ, Marshall M, Daniels IR. 2011;18(3):274-277. 2005;4(4):214-224. This product is designed to function as a barrier and provide protective coverage from the surrounding environment for acute and chronic wounds such as partial and full thickness wounds, pressure sores/ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor site/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. J Oral Maxillofac Surg. Human skin equivalents appeared to promote wound healing in3 ways: Delibaltov et al (2016) introduced an interactive cell analysis application, called CellECT, for 3D+t microscopy datasets. 2015;19(2):253-257. 2019;32(1):26-36. A clinical evaluation of Biobrane() and Suprathel() in acute burns and reconstructive surgery. When applied to a wound, these devices changes the healing response, resulting in remodeled, functional, site specific tissue. The wound bed was prepared by using either rough debridement or dermabrasion excision. Furthermore, chronic wounds often require other surgical interventions such as venous ablation or arterial intervention to achieve healing or prevent recidivism. 2006;19(6):310-322. SurGraft TL is a triple-layer amniotic tissue allograft produced from donated human amniotic membrane. Meyer-Ingold W. Wound therapy: Growth factors as agents to promote healing. 2004;62(4):489-496. Br J Nurs. Abdul and colleagues (2020) performed a systematic review and meta-analysis of human amniotic membrane as option for graft donor sites. Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. Foster K, Greenhalgh D, Gamelli R et al; FS 4IU VH S/D Clinical Study Group. Ann Thorac Surg. Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. 1994;28(2):95-105. Thavarajah D, De Lacy P, Hussain R, Redfern RM. Arch Surg. 2018;26(3):274-283. Cullum N, Petherick E. Pressure ulcers. Edelman DS, Hodde JP. Use of surgisis mesh in laparoscopic repair of hiatal hernias. Am J Sports Med. InnovaMatrix AC is the first Food and Drug Administration cleared medical device sourced from pig placenta. There is a lack of evidence in the peer-reviewed published medical literature to support the effectiveness of Relese. 2009;111(2):380-386. A single center experience. Holmes et al (2018) noted that early excision and autografting are standard of care (SOC) for deeper burns; however, donor sites are a source of significant morbidity. Kassolis JD, Reynolds MA. Mean duration to complete healing of the wound was 133 days (19 weeks) (range of 53 to 311 days). 92-0065. Kelechi TJ, Mueller M, Hankin CS, et al. 2005;125(1):37-41. Int Urogynecol J. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. The authors stated that the ReCell procedure took longer than skin grafts, mainly due to the time required by trypsin to digest intercellular bonds (20 mins). Int Wound J. Skin grafting for venous leg ulcers. Management of late complications of head and neck cancer and its treatment. Sobti N, Liao EC. 2013;(6):CD009111. Dumville JC, O'Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Postoperative cervical cord compression induced by hydrogel (DuraSeal):A possible complication. Abdominal sacrocolpopexy: Anatomic outcomes and complications with Pelvicol, autologous and synthetic graft materials. The study was also limited by small sample size (n = 15). 2022;19(5):1197-1209. Levenda AC, Sanders NR. Lancet. Lorenz RR, Dean RL, Hurley DB, et al. Medtech Innovation Briefing [MIB139]. Riboh JC, Saltzman BM, Yanke AB, Cole BJ. 2010;9(2):149-151. Repriza can also be used in a range of applications to augment soft tissue irregularities and for implantation in irregularities such as a depression over the nasal bridge. 2012;255(6):1037-1042. Both cohorts received standard wound care, including surgical debridement, moist wound care, and off-loading. Phillips LG, Robson MC, Smith DJ, et al. Barbul A, Gelly H, Masturzo A. The authors concluded that skin substitute usage in MMS reconstruction is not well-guided. 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. 2010;76(1):1-6. A retrospective multicenter study of the Artelon carpometacarpal joint implant. The use of a permanent dermal allograft in full-thickness burns of the hand and foot: A report of three cases. Non-watertight dural reconstruction in meningioma surgery: Results in 439 consecutive patients and a review of the literature. Still J, Glat P, Silverstein P, et al. Romanelli M, Dini V, Bertone M, et al. Rockville, MD: FDA;Oct 25, 2007. Treatment of pressure ulcers. 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. The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: Prospective randomized clinical trial. IV. Pilot study comparing the leak pressure of the sleeved stomach with and without reinforcement. Gaster RS, Berger AJ, Monica SD, et al. Ryssel H, Germann G, Riedel K, et al. 2014;4(2):62-65. Public Meeting Summary Report. cm. 1996;97(2):469-476. Multi-variate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. Clinically relevant mechanical testing of hernia graft constructs. the cost data were obtained from a CMS reimbursement schedule, and these do not reflect the actual cost of material across all clinical settings. The epithelial layer is facing the camera and will be wrapped around the anterior cruciate ligament allograft with this layer touching the graft. The dressing is intended to maintain a moist wound healing environment. 2012;38(3):307-318. Adv Skin Wound Care. 2012;130(5 Suppl 2):183S-193S. 2018;30(9):283-289. Brigido SA. Hundeshagen G, Collins VN, Wurzer P, et al. Muscle Nerve. 2000;26(4):379-387. Arch Facial Plast Surg. 2012;42(3):444-453. Perineal hernia repair with acellular dermal graft and suture anchor fixation. Choi YM, Campbell K, Levek C, et al. Arthroscopic superior capsular reconstruction with acellular dermal allograft using push-in anchors for glenoid fixation. 2014;156(4):902-908. Attachment# 16.055 . Early aggressive closure of the open abdomen. Clin Podiatr Med Surg. Rockville, MD: FDA; September 21, 2001. AlloDerm Regenerative Tissue Matrix . Wound Repair Regen. Caravaggi C, Francesco Grigoletto M, Scuderi N. Wound bed preparation with a dermal substitute (Hyalomatrix PA) facilitates re-epithelialization and haling: Results of a multicenter, prospective, observational study on complex chronic ulcers: The FAST Study. Kathju S, Lasko LA, Medich DS. Excluded were subjects with large ulcers (10 cm2 or greater), infection, Charcot foot, and inadequate circulation to the foot. Human split-thickness skin allograft from brain-dead donors. 2004;(1):CD003554. Mdry R, Struyna J, Stachura-Kuach A,et al. Thon SG, O'Malley L, 2nd, O'Brien MJ, Savoie FH, 3rd. U.S. Food and Drug Administration (FDA). Nilsson A, Wiig M, Alnehill H,et al. Limpert JN, Desai AR, Kumpf AL, et al. This ECM includes growth factors, fibronectin, laminin, hyaluronic acid, proteoglycans, and other proteins. Bioactive prosthetic material for treatment of hernias. 1999;25(3):256-261. Am J Surg. Semin Pediatr Surg. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: Long-term follow-up. A non-contact video analysis permitted normalization of stretch within the repair region. Vin F, Teot L, Meaume S. The healing properties of Promogran in venous leg ulcers. 2008;27(5):361-364. PelviSoft BioMesh augmentation of rectocele repair: The initial clinical experience in 35 patients. Resource Type: Patient Education Animations. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence:A prospective randomized three-year follow-up study. National Institute for Health and Clinical Excellence (NICE) Diabetic foot problems: Inpatient management of diabetic foot problems. Plast Reconstr Surg. The above policy is based on the following references: Last Review Bellows CF, Shadduck P, Helton WS, et al. WoundEx membrane allograft consists of dehydrated and decellularized human amniotic membrane that has been processed with proprietary HydraTek technology. Static treatment modalities in facial paralysis:A review. Biehl RC, Moore RD, Miklos JR,et al. Baltimore, MD: CMS; July 7, 2021. Al-Abed YA, Ayers J, Ayantunde A, Praveen BV. Mod Healthcare. A retrospective matched-cohort study of 3994 lower extremity wounds of multiple etiologies across 644 institutions comparing a bioactive human skin allograft, TheraSkin, plus standard of care, to standard of care alone. Yonehiro L, Burleson G, Sauer V. Use of a new acellular dermal matrix for treatment of nonhealing wounds in the lower extremities of patients with diabetes. A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. 2013;(6):CD009100. 2022a;10(12):e4707. Another drawback was insufficient data were available in the EMRs to factor limb vascularity and HbA1c into the matching scheme. Burns. Parra MW, Rodas EB, Niravel AA. Int J Burns Trauma. Am J Obstet Gynecol. Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. The cost of treatment per square centimeter for Mepilex Ag was considerably lower than that of Suprathel. However, the current data does not allow for such a direct comparison. Scott BG, Welsh FJ, Pham HQ, et al. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Silver-coated wound dressings produce sustained release of ionic silver to decrease the incidence of infection. Ostomy Wound Manage. These investigators stated that a large RCT that examines changes in wound area reduction and cytokines in active and sham treatment groups would give clinicians better insights regarding the effect of continuous topical oxygen on and timing and the expression of cytokines. Dumville JC, Deshpande S, O'Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. Accessed July 7, 2009. 95-0652. Guerrero L, Camacho B. 2012;25(6):253-260. Fourth Quarter, 2021 HCPCS Coding Cycle. Gomelsky A, Haverkorn RM, Simoneaux WJ,et al. Effectiveness measures were evaluated and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes up to 1 year following treatment. Successful treatment of two refractory venous stasis ulcers treated with a novel poly-N-acetyl glucosamine-derived membrane. Arch Plast Surg. 2011;37(8):1343-1348. Wangensteen KJ, Kalliainen LK. Ann Surg. Spine (Phila Pa 1976). Fewer dressing changes and easier overall management of the wounds contribute to its favorable profile. Biomaterials. Apis. Ann N Y Acad Sci. Growth factors: Therapeutic advances in wound healing. Tornier BioFiber Absorbable Biological Scaffold, and Tornier Collagen Coated BioFiber Scaffold, Veritas Collagen Matrix for use as an implant in the surgical repair of soft tissue deficiencies and all other indications, VersaWrap Tendon Protector for the management and protection of tendon injuries and all other indications, Viaflow / Viaflow C flowable placental tissue matrices, Vitagel surgical hemostat for wound healing and all other indications, Xwrap Amniotic Membrane-Derived Allograft. Use of DermaMatrix graft in oculoplastic surgery. NICE Clinical Guideline 119. Mayo Clin Proc. The use of composite acellular allodermis-ultrathin autograft on joint area in major burn patients--one year follow-up. Human reticular acellular dermal matrix in the healing of chronic diabetic foot ulcerations that failed standard conservative treatment: A retrospective crossover study. 2021;9(5):e3596. Ritz MC, Gallegos R, Canham MB, et al. J Adv Nurs. Limitations of the study include that it was retrospective and lacked a control group. In: BMJ Clinical Evidence. Silver-releasing dressings in treating chronic wounds. Thirty patientswith second-degree burn injuries were included in the study. Pilot trial of biovance collagen-based wound covering for diabetic ulcers. 2019b;16(1):122-130. It is supplied in 2 x 2 cm, 2 x 3 cm, 4 x 4 cm, 4 x 6 cm, and 6 x 8 cm sheets. J Am Col Certif Wound Spec. 2010;101(7):600-603. Inan I, Gervaz P, Hagen M, Morel P. Multimedia article. Procenta is supplied in a single use vial containing one 200 mg placental allograft, providing coverage for up to a 6 cm2 wound surface area. 2013;471(8):2455-2458. #: OF1-000331-en-USVersion: FLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for the Eclipse Total Shoulder SystemFile Type: Ref. J Shoulder Elbow Surg. J Surg Res. J Burn Care Rehabil. Acellular dermal matrix for mucogingival surgery: A meta-analysis. Edison, NJ: MTF; 2015. Vermeulen GM, Slijper H, Feitz R,et al. Khodadadi A, Olang O, Makhllough A, et al. Orthopedics. Durden F Jr, Tiwari P, Kocak E. Can the DermaClose device contribute to periwound tissue ischemia and necrosis:A case presentation and discussion? Though wounds were of different etiology diabetic foot ulcer, traumatic, surgical, and decubitus this did not appear to change outcomes. There are no peer-reviewed published studies evaluating the safety and efficacy of Restorigin. 2014;11(5):472-475. Jensen G, Katthagen JC, Alvarado L,et al. Stability is pleased to announce that our request for a Level II HCPCS code for AmnioCore Amniotic Membrane Allograft has been established . 2011;46(9):1759-1763. Interim results for a prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to standard moist wound therapy in the treatment of diabetic foot ulcers. Thamboo A, Thamboo A, Philpott C,et al. J Pediatr Orthop. Serena TE, Yaakov R, Moore S, et al. 510(k) Summary. Are biologic grafts effective for hernia repair? Centers for Medicare & Medicaid Services (CMS).
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