Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, noninferiority study

Jin Kyong Kim; Cho Rok Lee; Sang Wook Kang; Jong Ju Jeong; Kee Hyun Nam; Sung Rae Cho; Seongmoon Jo; Eun Young Kim; Ji Sup Yun; Hee Jin Park; Mi Sung Kim; Kwangsoon Kim; Sohee Lee; Ja Seong Bae; So Yeon Jun; Jihye Park; Jeong Soo Kim

doi:10.1371/journal.pone.0273215

Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, noninferiority study

Jin Kyong Kim, Cho Rok Lee, Sang Wook Kang, Jong Ju Jeong, Kee Hyun Nam, Sung Rae Cho, Seongmoon Jo, Eun Young Kim, Ji Sup Yun, Hee Jin Park, Mi Sung Kim, Kwangsoon Kim, Sohee Lee, Ja Seong Bae, So Yeon Jun, Jihye Park, Jeong Soo Kim

Department of Rehabilitation Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction 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.

Original language	English
Article number	e0273215
Journal	PloS one
Volume	17
Issue number	9 September
DOIs	https://doi.org/10.1371/journal.pone.0273215
Publication status	Published - 2022 Sept

Bibliographical note

Funding Information:
KHN This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI18C2359) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
© 2022 Kim et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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10.1371/journal.pone.0273215

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Kim, J. K., Lee, C. R., Kang, S. W., Jeong, J. J., Nam, K. H., Cho, S. R., Jo, S., Kim, E. Y., Yun, J. S., Park, H. J., Kim, M. S., Kim, K., Lee, S., Bae, J. S., Jun, S. Y., Park, J., & Kim, J. S. (2022). Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, noninferiority study. PloS one, 17(9 September), [e0273215]. https://doi.org/10.1371/journal.pone.0273215

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title = "Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, noninferiority study",

abstract = "Introduction MegaShield{\textregistered} 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{\textregistered} compared with Guardix-SG{\textregistered} 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{\textregistered} group or the Guardix-SG{\textregistered} 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{\textregistered} and control (Guardix-SG{\textregistered}) 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{\textregistered} is not inferior to that of Guardix-SG{\textregistered}. There were no device-related complications in both groups. Conclusion The efficacy and safety of MegaShield{\textregistered} were not inferior than those of Guardix-SG{\textregistered}. MegaShield{\textregistered} demonstrated the potential of ADM as a potential future anti-adhesive agent.",

author = "Kim, {Jin Kyong} and Lee, {Cho Rok} and Kang, {Sang Wook} and Jeong, {Jong Ju} and Nam, {Kee Hyun} and Cho, {Sung Rae} and Seongmoon Jo and Kim, {Eun Young} and Yun, {Ji Sup} and Park, {Hee Jin} and Kim, {Mi Sung} and Kwangsoon Kim and Sohee Lee and Bae, {Ja Seong} and Jun, {So Yeon} and Jihye Park and Kim, {Jeong Soo}",

note = "Funding Information: KHN This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI18C2359) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: {\textcopyright} 2022 Kim et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",

year = "2022",

month = sep,

doi = "10.1371/journal.pone.0273215",

language = "English",

volume = "17",

journal = "PLoS One",

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publisher = "Public Library of Science",

number = "9 September",

}

Kim, JK, Lee, CR, Kang, SW, Jeong, JJ, Nam, KH, Cho, SR, Jo, S, Kim, EY, Yun, JS, Park, HJ, Kim, MS, Kim, K, Lee, S, Bae, JS, Jun, SY, Park, J & Kim, JS 2022, 'Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, noninferiority study', PloS one, vol. 17, no. 9 September, e0273215. https://doi.org/10.1371/journal.pone.0273215

Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy : A randomized, multicenter, double-blind, noninferiority study. / Kim, Jin Kyong; Lee, Cho Rok; Kang, Sang Wook et al.

In: PloS one, Vol. 17, No. 9 September, e0273215, 09.2022.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy

T2 - A randomized, multicenter, double-blind, noninferiority study

AU - Kim, Jin Kyong

AU - Lee, Cho Rok

AU - Kang, Sang Wook

AU - Jeong, Jong Ju

AU - Nam, Kee Hyun

AU - Cho, Sung Rae

AU - Jo, Seongmoon

AU - Kim, Eun Young

AU - Yun, Ji Sup

AU - Park, Hee Jin

AU - Kim, Mi Sung

AU - Kim, Kwangsoon

AU - Lee, Sohee

AU - Bae, Ja Seong

AU - Jun, So Yeon

AU - Park, Jihye

AU - Kim, Jeong Soo

N1 - Funding Information: KHN This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI18C2359) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2022 Kim et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2022/9

Y1 - 2022/9

N2 - Introduction 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.

AB - Introduction 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.

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DO - 10.1371/journal.pone.0273215

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IS - 9 September

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Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, noninferiority study

Abstract

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