In:
PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 9 ( 2022-9-19), p. e0273215-
Abstract:
MegaShield ® is a newly developed temperature-sensitive anti-adhesive containing micronized acellular dermal matrix. The aim of this study was to investigate the efficacy and safety of MegaShield ® compared with Guardix-SG ® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy. Method We conducted a multicenter trial between October 2018 and March 2020 in patients undergoing total thyroidectomy. The patients were randomly assigned to either the MegaShield ® group or the Guardix-SG ® group. The primary outcome was the esophageal movement using marshmallow six weeks after the surgery and the secondary outcome was the assessed adhesion score. The safety assessment was also evaluated. Results The study included 70 patients each in the MegaShield ® and control (Guardix-SG ® ) groups. Baseline clinical characteristics, the mean score of marshmallow esophagography, and the sum of adhesion scores were not statistically different between the two groups. Inferiority test demonstrated that the efficacy of MegaShield ® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups. Conclusion The efficacy and safety of MegaShield ® were not inferior than those of Guardix-SG ® . MegaShield ® demonstrated the potential of ADM as a potential future anti-adhesive agent. Trial registration The name of trial registry CRIS (Clinical Research Information Service) https://cris.nih.go.kr/cris/index.jsp . (The full trial protocol can be accessed) Registration number: KCT0003204 .
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0273215
DOI:
10.1371/journal.pone.0273215.g001
DOI:
10.1371/journal.pone.0273215.t001
DOI:
10.1371/journal.pone.0273215.t002
DOI:
10.1371/journal.pone.0273215.t003
DOI:
10.1371/journal.pone.0273215.t004
DOI:
10.1371/journal.pone.0273215.t005
DOI:
10.1371/journal.pone.0273215.t006
DOI:
10.1371/journal.pone.0273215.t007
DOI:
10.1371/journal.pone.0273215.s001
DOI:
10.1371/journal.pone.0273215.s002
DOI:
10.1371/journal.pone.0273215.s003
DOI:
10.1371/journal.pone.0273215.s004
DOI:
10.1371/journal.pone.0273215.s005
DOI:
10.1371/journal.pone.0273215.s006
DOI:
10.1371/journal.pone.0273215.s007
DOI:
10.1371/journal.pone.0273215.r001
DOI:
10.1371/journal.pone.0273215.r002
DOI:
10.1371/journal.pone.0273215.r003
DOI:
10.1371/journal.pone.0273215.r004
DOI:
10.1371/journal.pone.0273215.r005
DOI:
10.1371/journal.pone.0273215.r006
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2022
detail.hit.zdb_id:
2267670-3
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