A 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. (Record no. 6614)

MARC details
000 -LEADER
fixed length control field 03428nam a22005417a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 210719s20212021 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0305-4179
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1016/j.burns.2021.04.021 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S0305-4179(21)00110-8 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 34099322
245 ## - TITLE STATEMENT
Title A 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 ## - Source
Source Burns. 47(5):1024-1037, 2021 08.
252 ## - Abbreviated Source
Abbreviated source Burns. 47(5):1024-1037, 2021 08.
252 ## - Abbreviated Source
Former abbreviated source Burns. 2021 Apr 23
253 ## - Journal Name
Journal name Burns : journal of the International Society for Burn Injuries
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2021
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Publication date 2021 Apr 23
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2021-07-19
268 ## - Previous citation
-- Burns. 2021 Apr 23
269 ## - Original dates
Original fiscal year FY2021
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1995 - present, Available in print through MWHC library:1996-2007
520 ## - SUMMARY, ETC.
Abstract CLINICAL TRIAL IDENTIFIER: NCT03005106. Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting.
520 ## - SUMMARY, ETC.
Abstract METHODS: 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 ## - SUMMARY, ETC.
Abstract OBJECTIVE: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.
520 ## - SUMMARY, ETC.
Abstract RESULTS: 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 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Burns
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Skin Transplantation
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Burns/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Skin
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Transplantation, Autologous
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Wound Healing
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Health Research Institute
656 ## - INDEX TERM--OCCUPATION
Department Firefighters' Burn and Surgical Research Laboratory
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shupp, Jeffrey W
790 ## - Authors
All authors Allen-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 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.burns.2021.04.021">https://dx.doi.org/10.1016/j.burns.2021.04.021</a>
Public note https://dx.doi.org/10.1016/j.burns.2021.04.021
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 07/19/2021   34099322 34099322 07/19/2021 07/19/2021 Journal Article

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