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Ekhtiari S, Adili AF, Memon M, et al. It is applied over a wound or burn site following wound preparation in multiple sites of care. You must log in or register to reply here. FDA News. use of acellular dermal matrix (ADM) (n = 75) versus. Currently, there is insufficient evidence to allow for proper evaluation regarding the effectiveness of this technology. 2002;137(7):822-827. Giordano S, Garvey PB, Baumann DP, et al. Int Wound J. Tissue Eng Part A. Soft tissue augmentation. Rockville, MD: FDA; October 10, 2007. AmnioRepair is indicated for use as a biological barrier or wound cover. Treatment of chronic diabetic lower extremity ulcers with advanced therapies:A prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. WoundEx Flow is stored at ambient temperature and has a 5-year shelf life. There is a lack of evidence regarding the effectiveness of the Procenta allograft. Int Wound J. Biomechanical, biochemical, and cellular properties. These included statistically adjusted results for Apligraf as reported in the product insert and the biweekly application for Talymed. Robinson PM, Muir LT. Foreign body reaction associated with Artelon: Report of three cases. Randomized phase II clinical trial of avotermin versus placebo for scar improvement. HHSA 290-2015-00005-I. 2015;75(2):201-204. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Surg Endosc. Cultured epithelial autografts in extensive burn coverage of severely traumatized patients: A five year single-center experience with 30 patients. At 4 weeks, 98 % of the ASCS-treated sites were healed compared with 100 % of the Controls. Colorectal Dis. Experience with the use of apligraf to heal complicated surgical and nonsurgical wounds in a private practice setting. Wiechula R. Post harvest management of split thickness skin graft donor sites:A systematic review. 2014;23(7):355-357. Incidence of complete wound closure at 14 weeks, donor site closure, pain, Health-Related Quality of Life (HRQoL), satisfaction, and safety were assessed in 52 patients. Available at: http://www.collagenmatrix.com/products-neurological.htm. Wilson TC, Wilson JA, Crim B, Lowery NJ. Reinforcing the staple line during laparoscopic sleeve gastrectomy: Prospective randomized clinical study comparing two different techniques. CPT further instructs: Do not report 65778, 65779 in conjunction with 65430, 65435, 65480. 2005;4(4):214-224. Dahlgren E, Kjlhede P; RPOP-PELVICOL Study Group. Ann Surg. Mean PAR at 12 weeks was 77.8% in the TheraSkin group compared with 49.6% in the SOC group (adjusted P = .0019). Caravaggi C, De Giglio R, Pritelli C, et al. A bioabsorbable collagen nerve cuff (NeuraGen) for repair of lingual and inferior alveolar nerve injuries:A case series. Acta Biomater. Ann Plast Surg. Nicolau I, Xie X, McGregor M, Dendukuri N. Evaluation of acellular dermal matrix for breast reconstruction: An update. Champagne BJ, O'Connor LM, Ferguson M,et al. PelviSoft BioMesh augmentation of rectocele repair: The initial clinical experience in 35 patients. Safety and efficacy of TransCyte for the treatment of partial-thickness burns. Successful grafting with EpiDex in pyoderma gangrenosum. 2018;39(2):261-267. Coccolini F, Lotti M, Bertoli P, et al. A clinical evaluation of Biobrane() and Suprathel() in acute burns and reconstructive surgery. A comparative, long-term assessment of four soft tissue substitutes. 2012;10(3):159-171. Drugs, Biologicals, and Radiopharmaceuticals. Use of surgisis for treatment of anterior and posterior vaginal prolapse. To apply, cut the rinsed Unite Biomatrix to a size slightly larger than the outline of the wound area and secure in place by sutures or staples. TranCyte was not indicated for chronic wounds. Natale F, La Penna C, Padoa A,et al. InnovaMatrix AC [website]. ASERNIP-S Report No. Leon-Villapalos J, Dziewulski P. Overview of surgical procedures used in the management of burn injuries. Multiple supplemental approvals have been added since the first approval, including an indication for treating diabetic foot ulcers. Lullove E. A Flowable Placental tissue matrix allograft in lower extremity injuries: A pilot study. Retrospective comparison of diabetic foot ulcer and venous stasis ulcer healing outcome between a dermal repair scaffold (PriMatrix) and a bilayered living cell therapy (Apligraf). De Angelis N, Felice P, Pellegrino G,et al. Billing and Coding: Amniotic Membrane Billing Guidelines for HCPCS Code Growth factors and wound healing in otolaryngology. Browne AC, Sibbald RG. DeCarbo WT. Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: An initial experience. However, no positive effect was demonstrated on the critical outcome (reduction in amputation). According to the manufacturer's website, TenoGlide provides a protective biocompatible interface, which provides a protective environment and gliding surface while the tendon is healing (e.g., tendons damaged by compression from trauma or after primary repair). In addition, the draft guideline stated that the use of skin substitute treatments for the inpatient management of diabetic foot problems should only be offered as part of a clinical trial (NICE, 2011). Talymedwas cleared for marketing under the 510(k) process (K102002) in July 2010 for "the management of wounds including: diabetic ulcers; venous ulcers; pressure wounds; ulcers caused by mixed vascular etiologies; full thickness and partial thickness wounds; second degree burns; surgical wounds-donor sites/grafts, post-Mohs surgery, post laser surgery, and other bleeding surface wounds; abrasions, lacerations; traumatic wounds healing by secondary intention; chronic vascular ulcers; dehisced surgical wounds.". REGUaRD is administered by a health care professional in a physician's office, outpatient surgery center, or acute care facility. Use of duraseal in repair of cerebrospinal fluid leaks. Diabetic foot problems: Inpatient management of diabetic foot problems (Draft). Ely EE, Figueroa NM, Gilot GJ. Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. Phillips LG, Robson MC, Smith DJ, et al. : A systematic review of the literature. 2014;22(6):688-693. 2013;79(5):476-482. Agence d'Evaluation des technologies et des Modes d'Intervention en Sante (AETMIS). Until comparative studies of this product have been made available, a thorough evaluation of its safety and effectiveness can not be completed. Litvack ZN, West GA, Delashaw JB, et al. Arch Dermatol. Summary of safety and effectiveness RECELL Autologous Cell Harvesting Device. Use of DermaMatrix graft in oculoplastic surgery. Children randomized to standard ointment dressings were significantly less likely to require 4 or more burn clinic visits than those in the Mepitel Ag (4 % versus 27 %; p = 0.004). The authors concluded that this study evaluated a novel application of topical oxygen therapy that has had a successful randomized clinical trial in patients with DFUs. Vermeulen H, van Hattem JM, Storm-Versloot MN, Ubbink DT. TransCyte is applied to a wound using sutures or other fixation method based on the size of the wound being treated. So K, McGrouther DA, Bush JA, et al. J Oral Maxillofac Surg. 2017;26(12):2158-2166. Am J Surg. Robson V, Dodd S, Thomas S. Standardized antibacterial honey (Medihoney) with standard therapy in wound care: Randomized clinical trial. Accessed January 22, 2008. Waltham, MA: UpToDate; reviewed December 2020. Cillo JE Jr, Caloss R, Miles BA, Ellis E 3rd. Cooke M, Tan EK, Mandrycky C,et al. 2007;193(3):360-363. Przegl Lek. Rahmanian-Schwarz A, Beiderwieden A, Willkomm LM,et al. Links to various non-Aetna sites are provided for your convenience only. Another drawback was that the database did not include specific measures of vascularity or hemoglobin A1c (HbA1c), and this may have contributed to the differences in the healing rates observed. A simplified approach for arthroscopic repair of rotator cuff tear with dermal patch augmentation. Centers for Medicare & Medicaid Services (CMS). Wounds 2017;29(7):E51-E54. Acellular dermal allograft for ventral hernia repair in the compromised surgical field. Primary surgical repair of anterior vaginal prolapse:A randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. Insufficient information was provided regarding randomization in this study. Surg Endosc. Basic principles of wound management. Ann Thorac Cardiovasc Surg. Wounds. 2013;(4):CD010182. Pro3-Placenta is single-layer amnion that is ideal for dermatological application such as topical wounds and burns. 2006;(2):CD002930. Wajon A, Vinycomb T, Carr E, et al. Solomon MP, Komlo C, Defrain M. Allograft materials in phalloplasty: A comparative analysis. J Craniofac Surg. Perit Dial Int. Sari E, Eryilmaz T, Tetik G, et al. 2014;80(10):999-1002. Dumville JC, Walter CJ, Sharp CA, Page T. Dressings for the prevention of surgical site infection. J Ind Microbiol Biotechnol. Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Foot care. The product is thawed in a sterile gloved hand for 5 minutes and cut and shaped to size prior to application following wound preparation. 2007;17(5):365-368. Burns. By providing a scaffold of extracellular matrix proteins, active growth factors and cytokines, this critical components facilitate healing and infection control. K081635. Suprathel is available in four sizes: 5 x 5 cm; 9 x 10 cm; 18 x 10 cm; and 18 x 23 cm square sheet membranes. Armstrong DG, Orgill DP, Galiano RD, et al. Brem H, Balledux J, Bloom T, et al. Favreau-Weltzer C, Bouchard D, Eleouet-Kaplan M, Pigot F. Response to Ratto et al., 'new Gore Bio-A() plug for anal fistula'. U.S. Food and Drug Adminstration (FDA). Towler MA, Rush EW, Richardson MK, Williams CL. Website: www.ventrismedical.com Email: info@ventrismedical.com Phone: (949) 706-5551 Fax: (949) 706-5552 Clin Geriatr Med. Use of skin substitute dressings in the treatment of staphylococcal scalded skin syndrome in neonates and young infants. Plachel F, Klatte-Schulz F, Minkus M, et al. Comparison of Suprathel and allograft skin in the treatment of a severe case of toxic epidermal necrolysis. PDF Skin Substitutes - PacificSource Gefasschirurgie. 2011;9:126. 2014;2014:704323. Interact Cardiovasc Thorac Surg. J Shoulder Elbow Surg. 2005;31(7):890-893. J Am Podiatr Med Assoc. Clinical article. 2014;25:73-78. Cheng AW, Abbas MA, Tejirian T. Outcome of abdominal wall hernia repair with biologic mesh: Permacol versus Strattice. Clarke S, Hagberg W, Kaufmann RA,et al. Podiatry Today. 510k no. Int Urogynecol J Pelvic Floor Dysfunct. Study conductd at Albany Medical Center and the University of Maryland, Institute of Human Virology through funding from Skin and Wound Allograft Institute, A Subsidiary of Lifenet Health. Huang YC, Jazayeri L, Le W, Yao J. Eur J Obstet Gynecol Reprod Biol. Vowden P, Romanelli M, Peter R, Bostrm A,et al. Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. Int Wound J. Fresh hypothermically stored amniotic allograft in the treatment of chronic nonhealing ulcers: A prospective case series. Treatment of complex anal fistulas with the collagen fistula plug. Surg Endosc. Singh DP, Zahiri HR, Gastman B,et al. Zerris VA, James KS, Roberts JB, et al. The high failure rate of biologic resurfacing of the glenoid in young patients with glenohumeral arthritis. Horizon Scanning Prioritising Summary. 2015;16(2):249-259. TenSIX acts as a scaffold to facilitate angiogenesis and migration of growth factors that stimulate cell migration. Special segment: soft tissue matrices--Apligraf bilayered skin substitute to augment healing of chronic wounds in diabetic patients. J Extra Corpor Technol. IV. Nelson EA, Bradley MD. Mihata T, Bui CNH, Akeda M, et al. Revitalon is a human tissue allograft made of donated amniotic membrane derived from the inner lining of donated placenta. Clin Ther. 2013;66(11):1534-1542. InnovaMatrix - Triad Life Sciences Hannon CP, Yanke AB, Farr J. Amniotic tissue modulation of knee pain - A focus on osteoarthritis. 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. TransCyte is intended for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement. The authors concluded that this animal study demonstrated the biocompatibility of ProLayer ADM. No unexpected tissue reaction or encapsulation was found. Genital prolapse repair using porcine skin implant and bilateral sacrospinous fixation: Midterm functional outcome and quality-of-life assessment. Ek AC, Lindgren M, Melhus A, et al. Spine J. 2010;20(4):323-327. Niederauer MQ, Michalek JE, Armstrong DG. 2003;24(1):42-48. Dis Colon Rectum. Long-term outcomes (>5-year follow-up) with porcine acellular dermal matrix (Permacol) in incisional hernias at risk for infection. Werber B, Martin E. A prospective study of 20 foot and ankle wounds treated with cryopreserved amniotic membrane and fluid allograft. 2003;26(10):2853-2859. Lopez-Monclova J, Targarona E, Balague C,et al. XCM Biologic Tissue Matrix is supplied sterile (hydrated) in a foil liner pouch. 2012;78(11):1255-1260. Bourdillon KA, Delury CP, Cullen BM. In: BMJ Clinical Evidence. 2011;56(10):1170-1176. Growth factors, cytokines, and perfusion were examined following therapy, similar to hyperbaric oxygen therapy (HBOT), although there was no difference in quantitative bacterial cultures. Available at: http://www.microvas.com. Champagne BJ. Dressings and topical agents for surgical wounds healing by secondary intention. 2008;63(1 Suppl 1):ONS182-ONS186; discussion ONS186-ONS187. Everts PA, Knape JT, Weibrich G, et al. Chin CJ, Kus L, Rotenberg BW. PI -108 Rev 3, 8/2016. Rejuvenation of the aging lip with an injectable acellular dermal graft (Cymetra). Am Surg. J Neurosurg Pediatr. 510(k) Summary. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Sawyer MAJ. New ovine polymer-reinforced bioscaffold in hiatal hernia repair. Arch Surg. Madison, WI: Mallinckrodt; revised June 2021. 2013;29(1):37-45. Baltimore, MD: CMS; March 30, 2022. Franklin Lakes, NJ Collagen Matrix; 2008. 2014;29(9):1125-1130. Cultured epithelial grafting using human amniotic membrane: The potential for using human amniotic epithelial cells as a cultured oral epithelium sheet. However, the current data does not allow for such a direct comparison. 2010;76(1):1-6. The most favorable estimates of product efficacy (i.e., those that were statistically significant compared with compression therapy) were used. Shah SS, Todkar JS, Shah PS. Applicant's suggested language: QXXXX "Cytal 3-Layer/6 Layer, per square centimeter." APPLICATION# 17.083 Zerbib P, Caiazzo R, Piessen G,et al. 2007;4(1):3-7. Bethesda, MD: National Library of Medicine; February 18, 2009. Ann N Y Acad Sci. 2010;76(10):1150-1153. de la Portilla F. Gore Bio-A() Fistula Plug for complex anal fistula: The results should be interpreted cautiously. Lancet. WoundEx membrane is intended to be used as a wound covering in the treatment of chronic and acute wounds. 2014;16(1):R47. 2011;7(5):637-642. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Children with a new burn injury to the upper or lower extremities, who presented to the burn clinic were eligible. Stilwell R, Delaney R. The biomechanics of ProLayer acellular dermal matrix: Suture retention strength. 2014;148(4):1370-1378. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. Adv Skin Wound Care. Ann Intern Med. 1998;19(6):531-537. 2015;31(8):1459-1465, Gilot GJ, Attia AK, Alvarez AM. Silver-releasing dressings in treating chronic wounds. Repair of abdominalwall defects with bovine pericardium. Subjects included adults with diabetic foot ulcers one month or more in duration. Treating providers are solely responsible for medical advice and treatment of members. Muttini A, Barboni B, Valbonetti L, et al. Tredget EE, Shankowsky HA, Groeneveld A, et al. Outcomes of biosynthetic and synthetic mesh in ventral hernia repair. Lullove (2015) noted that damaged connective tissue commonly leads to lower extremity injuries. Use of Integra artificial skin is associated with decreased length of stay for severely injured adult burn survivors. Increased incidence of pancreatic fistulas after the introduction of a bioabsorbable staple line reinforcement in distal pancreatic resections. Continuous diffusion of oxygen improves diabetic foot ulcer healing when compared with a placebo control: A randomised, double-blind, multicentre study. 2014;11(6):711-717. Yeen WC, Faber C, Caldeira C,et al. Moreover, these investigators stated that future prospective research that combines cost, clinical outcomes, as well as patient-centered outcomes could provide insight into the use of advanced modalities in this challenging patient population and enhance the development of more appropriate quality measures and reimbursement models to ensure smarter spending for this growing and costly population. 2014(4):1-4. Cell therapy for secondary osteonecrosis of the femoral condyles using the Cellect DBM System: A preliminary report. 2005;30(2):380-389. Gilbert TL, Griffin N, Moffett J, et al. A novel treatment for venous leg ulcers. Quiroz LH, Gutman RE, Shippey S,et al. 2007;(1):CD001836. A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair. J Diabetes Complications. -decreased incision size. Arthroscopic stabilization of acromioclavicular joint dislocation using the AC graftrope system. Treatment of deep partial thickness and indeterminate depth facial burn wounds with water-jet debridement and a biosynthetic dressing. 2010;81(2):237-244. Thompson P, Hanson DS, Langemo D, Anderson J. Utility of acellular allograft dermis in the care of elderly burn patients. Int J Low Extrem Wounds. The efficacy and safety of Grafix() for the treatment of chronic diabetic foot ulcers: Results of a multi-centre, controlled, randomised, blinded, clinical trial. 2006;22(5):534-538. Sheffield, UK: University of Sheffield; 2003. VIM human amniotic membrane allograft originates from human tissue and is for homologous use. Comparative evaluation of the antimicrobial activity of ACTICOAT antimicrobial barrier dressing. Moore AM, MacEwan M, Santosa KB,et al. Early aggressive closure of the open abdomen. It is highly permeable to oxygen and water vapor, providing a favorable environment for wound healing. TEI Biosciences. The Provant Wound Closure System (Regenesis Biomedical Inc., Scottsdale, AZ) uses a low-level radiofrequency signal that proponents state accelerates healing of chronic wounds by stimulating the production of endogenous growth factors and the proliferation of fibroblasts and epithelial cells, in a process the manufacturer has labeled "Cell Proliferation Induction" or CPI. Efficacy of interference screw and double-docking methods using palmaris longus and GraftJacket for medial collateral ligament reconstruction of the elbow. Two-step autologous grafting using HYAFF scaffolds in treating difficult diabetic foot ulcers: Results of a multicenter, randomized controlled clinical trial with long-term follow-up. J Cardiothorac Surg. 1998;15(1):129-137. Int Wound J. Int Wound J. Endoscopic reconstruction of anterior and middle cranial fossa defects using acellular dermal allograft. SurGraft TL is a triple-layer amniotic tissue allograft produced from donated human amniotic membrane. Osbun JW, Ellenbogen RG, Chesnut RM,et al. Eur Urol. Use of Medihoney as a non-surgical therapy for chronic pressure ulcers in patients with spinal cord injury. 2007;43(6):512-515. Topfer L, Hailey D. Over-the-counter antimicrobial bandages (Acticoat). Singh et al conducted a single center prospective randomized clinical trial in India consisting of 30 patients with ulcers undergoing STSG. Spine (Phila Pa 1976). Arthrosc Tech. Bronchoscopic removal of staple-line reinforcement material. 2014;14:e36. 2019;31(10):246-251. There are no peer-reviewed published studies evaluating the safety and efficacy of Restorigin. PDF January 2020 Update of the Ambulatory Surgical Center (ASC - CMS J Bone Joint Surg Am. Shealy FG Jr, DeLoach ED. 2012;21(5):236, 238, 240, 242-243. 2008;60(1):76-80. Dermagraft in the treatment of diabetic foot ulcers. Plast Reconstr Surg. Fahey C. Experience with a new human skin equivalent for healing venous leg ulcers. 2014;27(11):513-516. 2015;44(4):E117-E122. 2016;25 Suppl 7:S18-S25. 2017;46(6):266-278, Makovicka JL, Chung AS, Patel KA, et al. naturally occurring, non-cross-linked extracellular matrix; completely resorbable; contains multiple naturally occurring growth factors; patients were followed for only 1 week following complete healing. J Wound Care. The use of Hyalomatrix PA in the treatment of deep partial-thickness burns. 2017;Special Issue:1-9. 2014;18(3):335-339. 2006;63(4):255-258. Foot Ankle Int. Ann Med Surg (Lond). It is supplied in sizes: 2cm x 2cm, 4cm x 4cm, 6cm x 6cm 10cm x 10cm; and 12cm x 12cm. Breuing KH, Colwell AS. Topical silver for treating infected wounds. 2011;13(1):94-104. Vin F, Teot L, Meaume S. The healing properties of Promogran in venous leg ulcers. Developed to fill soft tissue defects and bone voids and to convey anti-microbial and anti-inflammatory capabilities, granulized amniotic membrane and amniotic fluid does not require fetal death, because its procurement is performed with maternal consent during birth. Br J Surg. 2013;10(1):44-46. The Boston Scientific Web site promotes Repliform for pelvic floor repair and says it "is intended for the repair or replacement of damaged or inadequate integumental tissue such to repair enteroceles, rectoceles and/or cystoceles and for pelvic floor reinforcement.". Viscolelasticity of burned skin was elevated compared with unburned skin in the Mepilex Ag group at 1 month post burn. 2012;18(5):375-384. David-Montefiore E, Barranger E, Dubernard G,et al. 2008 ;66(10):2058-2062. Chicago, IL: BCBSA; November 2001;16(12). Sarr MG, Hutcher NE, Snyder S,et al. Successful treatment of a patient with an extraordinarily large deep burn. Additionally, HAM proved to more effective than routine dressings with regard to secondary outcomes. Schneider KH, Aigner P, Holnthoner W, et al. Scalp reconstruction using dermal induction template: State of the art and personal experience. Ann Plast Surg. The manufacturer states that Stravix is currently indicated for inpatient surgical applications only, including as a wound cover in deep, acute wounds; surgical wound repair; and the majority of applications are surgical -- below the knee, leg and foot tendon repairs, and neurovascular repair. Another consideration was the application regimen used by the clinicians treating with BSA. Morgan DM, Dunn RL, Fenner DE, et al. 2011;2(3):495-501. Inguinal hernia repair with porcine small intestine submucosa: 3-year follow-up results of a randomized controlled trial of Lichtenstein's repair with polypropylene mesh versus Surgisis Inguinal Hernia Matrix. Insufficient details of randomization was noted in this study. Surg Technol Int. Sare JL. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. HCPCS Codes Product HCPCS Codes Layer Matrix duration for which standard wound therapy has failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of 0.70 Clinically relevant mechanical testing of hernia graft constructs. Clin Oral Implants Res. According to the manufacturer Amino Technology, ProMatrX ACF is commonly used in the treatment of chronic wounds that are most prevalent in older populations, particularly in patients with Type I diabetes. 2020a;28(1):81-89. 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). Adv Skin Wound Care. Baltimore, MD: CMS; December 2, 2021c. For amniotic tissue companies, this was basically a rubber-stamping session, until recently. J Oral Maxillofac Surg. Int J Burns Trauma. Arthroscopically assisted stabilization of chronic AC-joint instabilities in GraftRope technique with an additive horizontal tendon augmentation. 2018;2(4);186-195. 2016;4(10):e1095. 2003;69(12):1025-1029. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. Injectable skin fillers. Adv Skin Wound Care. 2014;30(3):289-298. Long-term patients reported higher satisfaction with ReCell donor site outcomes compared with the Controls. There was an increase from baseline to week 1 in transforming growth factor (TGF) (p =0.008), tumor necrosis factor (TNF) (p =0.014), vascular endothelial growth factor (VEGF) (p =0.008), platelet derived growth factor (PDGF) (p =0.087), and insulinlike growth factor1 (IGF1) (p =0.058); baseline to week 2 in TGF (p =0.010), VEGF (p =0.051), and interleukin-6 (IL6) (p =0.031); and baseline to week 3 with TGF (p =0.055) and IL6 (p =0.054). The authors concluded that these findings demonstrated that wound-related costs, product waste, amputations, and frequency of applications are lower for CHSA than DSS. Wound Repair Regen. Nilsson A, Liljensten E, Bergstrm C, Sollerman C. Results from a degradable TMC joint Spacer (Artelon) compared with tendon arthroplasty. 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. 2007;50(9):1465. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Kassolis JD, Reynolds MA. Skin and Soft Tissue Substitutes - Medical Clinical Policy - Aetna J Biomed Mater Res B Appl Biomater. The authors indicated that further randomized controlled trials are warranted to support this current study. Comparison of two different superior capsule reconstruction methods in the treatment of chronic irreparable rotator cuff tears: A biomechanical and histologic study in rabbit models. Ann Plastic Surg. Prepared by the Health Services Research Unit, University of Aberdeen for the National Institute for Health and Clinical Excellence Interventional Procedures Programme. Int Wound J. An open randomized controlled multicenter study. Cazzell S, Vayser D, Pham H, et al. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers:A prospective randomized multicenter clinical trial. 2016;25(10):585-592. The investigators explained that the therapy, known as continuous diffusion of oxygen (CDO), delivers pure oxygen to the wound at low flow rates, preserves patient mobility, showed significant benefits in animal studies and received FDA clearance in August 2009. Renuva Allograft Adipose Matrix may also be used for the reinforcement or supplemental support in underlying adipose tissue matrix as the result of damage or naturally occurring defects e.g., cleft lip, Parry-Romberg syndrome, and facial LDS." Am J Obstet Gynecol. Use of AlloDerm in primary nipple reconstruction to improve long-term nippleprojection. Frykberg RG, Gibbons GW, Walters JL, et al. Burns. K012814. Once removed from the vial, it is applied into the wound bed by a physician. Chronic ulcers: MATRIDERM() system in smoker, cardiopathic, and diabetic patients. Case report and review of the literature. Faga A, Nicoletti G, Brenta F,et al. London, UK: NICE; June 2008. Edmonds M; European and Australian Apligraf Diabetic Foot Ulcer Study Group. Limpert JN, Desai AR, Kumpf AL, et al. 2011;127(6):148e-149e. Lanier ST, Wang ED, Chen JJ, et al. The authors concluded that the most expensive AWCM for the treatment of VLUs did not appear to provide the greatest comparative clinical or cost efficacy.
