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 |