Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study
MegaShield.sup.® 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.sup.® compared with Guardix-SG.sup.® in the prevention of adhesions in patients undergoing bilateral...
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| Veröffentlicht in: | PloS one 2022-09, Vol.17 (9), p.e0273215-e0273215 |
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| creator | Kim, Jin Kyong Lee, Cho Rok Kang, Sang-Wook Jeong, Jong Ju Nam, Kee-Hyun Cho, Sung-Rae Jo, Seongmoon Kim, Eun Young Yun, Ji-Sup Park, Hee Jin Kim, Mi Sung Kim, Kwangsoon Lee, Sohee Bae, Ja Seong Jun, So Yeon Park, Jihye Kim, Jeong Soo |
| description | MegaShield.sup.® 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.sup.® compared with Guardix-SG.sup.® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy. 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.sup.® group or the Guardix-SG.sup.® 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. The study included 70 patients each in the MegaShield.sup.® and control (Guardix-SG.sup.®) 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.sup.® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups. The efficacy and safety of MegaShield.sup.® were not inferior than those of Guardix-SG.sup.® . MegaShield.sup.® demonstrated the potential of ADM as a potential future anti-adhesive agent. |
| doi_str_mv | 10.1371/journal.pone.0273215 |
| format | Article |
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The aim of this study was to investigate the efficacy and safety of MegaShield.sup.® compared with Guardix-SG.sup.® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy. 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.sup.® group or the Guardix-SG.sup.® 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. The study included 70 patients each in the MegaShield.sup.® and control (Guardix-SG.sup.®) 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.sup.® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups. The efficacy and safety of MegaShield.sup.® were not inferior than those of Guardix-SG.sup.® . MegaShield.sup.® demonstrated the potential of ADM as a potential future anti-adhesive agent.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0273215</identifier><identifier>PMID: 36121791</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Adhesion ; Adhesions ; Adhesives ; Biology and Life Sciences ; Biomedical materials ; Blood diseases ; Body temperature ; Cancer ; Clinical trials ; Complications ; Complications and side effects ; Double-blind studies ; Effectiveness ; Engineering and Technology ; Esophagus ; Hospitals ; HyperText Markup Language ; Laboratories ; Medicine and Health Sciences ; Motility ; Patients ; Prevention ; Questionnaires ; Research and Analysis Methods ; Safety ; Skin & tissue grafts ; Surgeons ; Surgery ; Thyroid gland ; Thyroidectomy</subject><ispartof>PloS one, 2022-09, Vol.17 (9), p.e0273215-e0273215</ispartof><rights>COPYRIGHT 2022 Public Library of Science</rights><rights>2022 Kim et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2022 Kim et al 2022 Kim et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c599t-2f745be526fab0c337fbbe1ba4593afffeba6989a5f2cd2e7cf34ae41f3fa7183</citedby><cites>FETCH-LOGICAL-c599t-2f745be526fab0c337fbbe1ba4593afffeba6989a5f2cd2e7cf34ae41f3fa7183</cites><orcidid>0000-0002-1523-1544 ; 0000-0002-4155-6035 ; 0000-0001-5121-8462 ; 0000-0002-9982-7838 ; 0000-0002-3135-0586</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9484646/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9484646/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids></links><search><contributor>Vall-llosera Camps, Miquel</contributor><creatorcontrib>Kim, Jin Kyong</creatorcontrib><creatorcontrib>Lee, Cho Rok</creatorcontrib><creatorcontrib>Kang, Sang-Wook</creatorcontrib><creatorcontrib>Jeong, Jong Ju</creatorcontrib><creatorcontrib>Nam, Kee-Hyun</creatorcontrib><creatorcontrib>Cho, Sung-Rae</creatorcontrib><creatorcontrib>Jo, Seongmoon</creatorcontrib><creatorcontrib>Kim, Eun Young</creatorcontrib><creatorcontrib>Yun, Ji-Sup</creatorcontrib><creatorcontrib>Park, Hee Jin</creatorcontrib><creatorcontrib>Kim, Mi Sung</creatorcontrib><creatorcontrib>Kim, Kwangsoon</creatorcontrib><creatorcontrib>Lee, Sohee</creatorcontrib><creatorcontrib>Bae, Ja Seong</creatorcontrib><creatorcontrib>Jun, So Yeon</creatorcontrib><creatorcontrib>Park, Jihye</creatorcontrib><creatorcontrib>Kim, Jeong Soo</creatorcontrib><title>Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study</title><title>PloS one</title><description>MegaShield.sup.® 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.sup.® compared with Guardix-SG.sup.® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy. 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.sup.® group or the Guardix-SG.sup.® 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. The study included 70 patients each in the MegaShield.sup.® and control (Guardix-SG.sup.®) 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.sup.® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups. The efficacy and safety of MegaShield.sup.® were not inferior than those of Guardix-SG.sup.® . MegaShield.sup.® demonstrated the potential of ADM as a potential future anti-adhesive agent.</description><subject>Adhesion</subject><subject>Adhesions</subject><subject>Adhesives</subject><subject>Biology and Life Sciences</subject><subject>Biomedical materials</subject><subject>Blood diseases</subject><subject>Body temperature</subject><subject>Cancer</subject><subject>Clinical trials</subject><subject>Complications</subject><subject>Complications and side effects</subject><subject>Double-blind studies</subject><subject>Effectiveness</subject><subject>Engineering and Technology</subject><subject>Esophagus</subject><subject>Hospitals</subject><subject>HyperText Markup Language</subject><subject>Laboratories</subject><subject>Medicine and Health Sciences</subject><subject>Motility</subject><subject>Patients</subject><subject>Prevention</subject><subject>Questionnaires</subject><subject>Research and Analysis Methods</subject><subject>Safety</subject><subject>Skin & tissue grafts</subject><subject>Surgeons</subject><subject>Surgery</subject><subject>Thyroid 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and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study</title><author>Kim, Jin Kyong ; Lee, Cho Rok ; Kang, Sang-Wook ; Jeong, Jong Ju ; Nam, Kee-Hyun ; Cho, Sung-Rae ; Jo, Seongmoon ; Kim, Eun Young ; Yun, Ji-Sup ; Park, Hee Jin ; Kim, Mi Sung ; Kim, Kwangsoon ; Lee, Sohee ; Bae, Ja Seong ; Jun, So Yeon ; Park, Jihye ; Kim, Jeong Soo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c599t-2f745be526fab0c337fbbe1ba4593afffeba6989a5f2cd2e7cf34ae41f3fa7183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adhesion</topic><topic>Adhesions</topic><topic>Adhesives</topic><topic>Biology and Life Sciences</topic><topic>Biomedical materials</topic><topic>Blood diseases</topic><topic>Body temperature</topic><topic>Cancer</topic><topic>Clinical trials</topic><topic>Complications</topic><topic>Complications and side effects</topic><topic>Double-blind studies</topic><topic>Effectiveness</topic><topic>Engineering and Technology</topic><topic>Esophagus</topic><topic>Hospitals</topic><topic>HyperText Markup Language</topic><topic>Laboratories</topic><topic>Medicine and Health Sciences</topic><topic>Motility</topic><topic>Patients</topic><topic>Prevention</topic><topic>Questionnaires</topic><topic>Research and Analysis Methods</topic><topic>Safety</topic><topic>Skin & tissue grafts</topic><topic>Surgeons</topic><topic>Surgery</topic><topic>Thyroid gland</topic><topic>Thyroidectomy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Jin Kyong</creatorcontrib><creatorcontrib>Lee, Cho Rok</creatorcontrib><creatorcontrib>Kang, Sang-Wook</creatorcontrib><creatorcontrib>Jeong, Jong Ju</creatorcontrib><creatorcontrib>Nam, Kee-Hyun</creatorcontrib><creatorcontrib>Cho, 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Jin Kyong</au><au>Lee, Cho Rok</au><au>Kang, Sang-Wook</au><au>Jeong, Jong Ju</au><au>Nam, Kee-Hyun</au><au>Cho, Sung-Rae</au><au>Jo, Seongmoon</au><au>Kim, Eun Young</au><au>Yun, Ji-Sup</au><au>Park, Hee Jin</au><au>Kim, Mi Sung</au><au>Kim, Kwangsoon</au><au>Lee, Sohee</au><au>Bae, Ja Seong</au><au>Jun, So Yeon</au><au>Park, Jihye</au><au>Kim, Jeong Soo</au><au>Vall-llosera Camps, Miquel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study</atitle><jtitle>PloS one</jtitle><date>2022-09-19</date><risdate>2022</risdate><volume>17</volume><issue>9</issue><spage>e0273215</spage><epage>e0273215</epage><pages>e0273215-e0273215</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>MegaShield.sup.® 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.sup.® compared with Guardix-SG.sup.® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy. 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.sup.® group or the Guardix-SG.sup.® 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. The study included 70 patients each in the MegaShield.sup.® and control (Guardix-SG.sup.®) 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.sup.® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups. The efficacy and safety of MegaShield.sup.® were not inferior than those of Guardix-SG.sup.® . MegaShield.sup.® demonstrated the potential of ADM as a potential future anti-adhesive agent.</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>36121791</pmid><doi>10.1371/journal.pone.0273215</doi><tpages>e0273215</tpages><orcidid>https://orcid.org/0000-0002-1523-1544</orcidid><orcidid>https://orcid.org/0000-0002-4155-6035</orcidid><orcidid>https://orcid.org/0000-0001-5121-8462</orcidid><orcidid>https://orcid.org/0000-0002-9982-7838</orcidid><orcidid>https://orcid.org/0000-0002-3135-0586</orcidid><oa>free_for_read</oa></addata></record> |
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| language | eng |
| recordid | cdi_plos_journals_2715763407 |
| source | DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adhesion Adhesions Adhesives Biology and Life Sciences Biomedical materials Blood diseases Body temperature Cancer Clinical trials Complications Complications and side effects Double-blind studies Effectiveness Engineering and Technology Esophagus Hospitals HyperText Markup Language Laboratories Medicine and Health Sciences Motility Patients Prevention Questionnaires Research and Analysis Methods Safety Skin & tissue grafts Surgeons Surgery Thyroid gland Thyroidectomy |
| title | Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T19%3A39%3A32IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20safety%20of%20temperature-sensitive%20acellular%20dermal%20matrix%20in%20prevention%20of%20postoperative%20adhesion%20after%20thyroidectomy:%20A%20randomized,%20multicenter,%20double-blind,%20non-inferiority%20study&rft.jtitle=PloS%20one&rft.au=Kim,%20Jin%20Kyong&rft.date=2022-09-19&rft.volume=17&rft.issue=9&rft.spage=e0273215&rft.epage=e0273215&rft.pages=e0273215-e0273215&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0273215&rft_dat=%3Cgale_plos_%3EA718366104%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2715763407&rft_id=info:pmid/36121791&rft_galeid=A718366104&rft_doaj_id=oai_doaj_org_article_8d613e52e11d47cdaf01af7cb470b5ae&rfr_iscdi=true |