000			03428nam a22005417a 4500
008			210719s20212021 xxu||||| |||| 00| 0 eng d
022			_a0305-4179
024			_a10.1016/j.burns.2021.04.021 [doi]
024			_aS0305-4179(21)00110-8 [pii]
040			_aOvid MEDLINE(R)
099			_a34099322
245			_aA phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft R construct in patients with deep partial-thickness thermal burns.
251			_aBurns. 47(5):1024-1037, 2021 08.
252			_aBurns. 47(5):1024-1037, 2021 08.
252			_zBurns. 2021 Apr 23
253			_aBurns : journal of the International Society for Burn Injuries
260			_c2021
260			_fFY2022
260			_p2021 Apr 23
265			_saheadofprint
265			_sppublish
266			_d2021-07-19
268			_aBurns. 2021 Apr 23
269			_fFY2021
501			_aAvailable online from MWHC library: 1995 - present, Available in print through MWHC library:1996-2007
520			_aCLINICAL TRIAL IDENTIFIER: NCT03005106. Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
520			_aCONCLUSIONS: Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting.
520			_aMETHODS: Patients aged >=18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (<=2000cm2 total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year.
520			_aOBJECTIVE: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.
520			_aRESULTS: Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P<.0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%).
546			_aEnglish
650			_a*Burns
650			_a*Skin Transplantation
650			_aAdult
650			_aBurns/su [Surgery]
650			_aHumans
650			_aSkin
650			_aTransplantation, Autologous
650			_aTreatment Outcome
650			_aWound Healing
651			_aMedStar Health Research Institute
656			_aFirefighters' Burn and Surgical Research Laboratory
657			_aJournal Article
700			_aShupp, Jeffrey W
790			_aAllen-Hoffmann BL, Cancio L, Carson J, Carter JE, Comer AR, Foster K, Gibson ALF, Holmes JH 4th, Joe V, Kahn S, Litt J, Lokuta MA, Rizzo J, Short T, Shupp JW, Smiell JM, Smith D
856			_uhttps://dx.doi.org/10.1016/j.burns.2021.04.021 _zhttps://dx.doi.org/10.1016/j.burns.2021.04.021
942			_cART _dArticle
999			_c6614 _d6614