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Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies

BACKGROUND: Incisional negative-pressure wound therapy (iNPWT) is widely adopted by different disciplines for multiple indications. Questions about the most appropriate uses and value of iNPWT have been raised. METHODS: An open-label within-patient RCT was conducted in transgender men undergoing gen...

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Autores principales: Timmermans, F W, Mokken, S E, Smit, J M, Zwanenburg, P R, van Hout, N, Bouman, M B, Middelkoop, E, Mullender, M G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364878/
https://www.ncbi.nlm.nih.gov/pubmed/34244715
http://dx.doi.org/10.1093/bjs/znab204
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author Timmermans, F W
Mokken, S E
Smit, J M
Zwanenburg, P R
van Hout, N
Bouman, M B
Middelkoop, E
Mullender, M G
author_facet Timmermans, F W
Mokken, S E
Smit, J M
Zwanenburg, P R
van Hout, N
Bouman, M B
Middelkoop, E
Mullender, M G
author_sort Timmermans, F W
collection PubMed
description BACKGROUND: Incisional negative-pressure wound therapy (iNPWT) is widely adopted by different disciplines for multiple indications. Questions about the most appropriate uses and value of iNPWT have been raised. METHODS: An open-label within-patient RCT was conducted in transgender men undergoing gender-affirming mastectomies. The objective was to determine the effect of iNPWT as a substitute for standard dressing and suction drains on wound healing complications. One chest side was randomized to receive the iNPWT intervention, and the other to standard dressing with suction drain. The primary endpoints were wound healing complications (haematoma, seroma, infection, and dehiscence) after three months. Additional outcomes were pain according to a numerical rating scale and patient satisfaction one week after surgery. RESULTS: Eighty-five patients were included, of whom 81 received both the iNPWT and standard treatment. Drain removal criteria were met within 24 h in 95 per cent of the patients. No significant decrease in wound healing complications was registered on the iNPWT side, but the seroma rate was significantly increased. In contrast, patients experienced both significantly less pain and increased comfort on the iNPWT side. No medical device-related adverse events were registered. CONCLUSION: Substituting short-term suction drains with iNPWT in gender-affirming mastectomies increased the seroma rates and did not decrease the amount of wound healing complications. Registration number: NTR7412 (Netherlands Trial Register).
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spelling pubmed-103648782023-07-31 Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies Timmermans, F W Mokken, S E Smit, J M Zwanenburg, P R van Hout, N Bouman, M B Middelkoop, E Mullender, M G Br J Surg Randomized Clinical Trials BACKGROUND: Incisional negative-pressure wound therapy (iNPWT) is widely adopted by different disciplines for multiple indications. Questions about the most appropriate uses and value of iNPWT have been raised. METHODS: An open-label within-patient RCT was conducted in transgender men undergoing gender-affirming mastectomies. The objective was to determine the effect of iNPWT as a substitute for standard dressing and suction drains on wound healing complications. One chest side was randomized to receive the iNPWT intervention, and the other to standard dressing with suction drain. The primary endpoints were wound healing complications (haematoma, seroma, infection, and dehiscence) after three months. Additional outcomes were pain according to a numerical rating scale and patient satisfaction one week after surgery. RESULTS: Eighty-five patients were included, of whom 81 received both the iNPWT and standard treatment. Drain removal criteria were met within 24 h in 95 per cent of the patients. No significant decrease in wound healing complications was registered on the iNPWT side, but the seroma rate was significantly increased. In contrast, patients experienced both significantly less pain and increased comfort on the iNPWT side. No medical device-related adverse events were registered. CONCLUSION: Substituting short-term suction drains with iNPWT in gender-affirming mastectomies increased the seroma rates and did not decrease the amount of wound healing complications. Registration number: NTR7412 (Netherlands Trial Register). Oxford University Press 2021-07-09 /pmc/articles/PMC10364878/ /pubmed/34244715 http://dx.doi.org/10.1093/bjs/znab204 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Randomized Clinical Trials
Timmermans, F W
Mokken, S E
Smit, J M
Zwanenburg, P R
van Hout, N
Bouman, M B
Middelkoop, E
Mullender, M G
Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
title Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
title_full Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
title_fullStr Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
title_full_unstemmed Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
title_short Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
title_sort within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies
topic Randomized Clinical Trials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364878/
https://www.ncbi.nlm.nih.gov/pubmed/34244715
http://dx.doi.org/10.1093/bjs/znab204
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