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The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial
BACKGROUND: Cleansing of the vulva and perineum is recommended during preparation for vaginal delivery, and special attention is paid to cleansing before episiotomy because episiotomy is known to increase the risk of perineal wound infection and/or dehiscence. However, the optimal method of perineal...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942633/ https://www.ncbi.nlm.nih.gov/pubmed/36810189 http://dx.doi.org/10.1186/s13063-023-07101-w |
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author | Jung, Young Mi Lee, Seung Mi Kim, So Yeon Chung, Jin Hoon Won, Hye-Sung Lee, Kyung A Park, Mi Hye Cho, Geum Joon Oh, Min-Jeong Choi, Eun Saem Ahn, Ki Hoon Hong, Soon-Cheol Sung, Ji-Hee Roh, Cheong-Rae Kim, Sun Min Kim, Byoung Jae Kim, Hyeon Ji Oh, Kyung Joon Hong, Subeen Park, In Yang Park, Joong Shin |
author_facet | Jung, Young Mi Lee, Seung Mi Kim, So Yeon Chung, Jin Hoon Won, Hye-Sung Lee, Kyung A Park, Mi Hye Cho, Geum Joon Oh, Min-Jeong Choi, Eun Saem Ahn, Ki Hoon Hong, Soon-Cheol Sung, Ji-Hee Roh, Cheong-Rae Kim, Sun Min Kim, Byoung Jae Kim, Hyeon Ji Oh, Kyung Joon Hong, Subeen Park, In Yang Park, Joong Shin |
author_sort | Jung, Young Mi |
collection | PubMed |
description | BACKGROUND: Cleansing of the vulva and perineum is recommended during preparation for vaginal delivery, and special attention is paid to cleansing before episiotomy because episiotomy is known to increase the risk of perineal wound infection and/or dehiscence. However, the optimal method of perineal cleansing has not been established, including the choice of antiseptic agent. To address this issue, we designed a randomized controlled trial to examine whether skin preparation with chlorhexidine-alcohol is superior to povidone-iodine for the prevention of perineal wound infection after vaginal delivery. METHODS: In this multicenter randomized controlled trial, term pregnant women who plan to deliver vaginally after episiotomy will be enrolled. The participants will be randomly assigned to use antiseptic agents for perineal cleansing (povidone-iodine or chlorhexidine-alcohol). The primary outcome is superficial or deep perineal wound infection within 30 days after vaginal delivery. The secondary outcomes are the length of hospital stay, physician office visits, or hospital readmission for infection-related complications, endometritis, skin irritations, and allergic reactions. DISCUSSION: This study will be the first randomized controlled trial aiming to determine the optimal antiseptic agent for the prevention of perineal wound infections after vaginal delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT05122169. First submitted date on 8 November 2021. First posted date on 16 November 2021 |
format | Online Article Text |
id | pubmed-9942633 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-99426332023-02-22 The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial Jung, Young Mi Lee, Seung Mi Kim, So Yeon Chung, Jin Hoon Won, Hye-Sung Lee, Kyung A Park, Mi Hye Cho, Geum Joon Oh, Min-Jeong Choi, Eun Saem Ahn, Ki Hoon Hong, Soon-Cheol Sung, Ji-Hee Roh, Cheong-Rae Kim, Sun Min Kim, Byoung Jae Kim, Hyeon Ji Oh, Kyung Joon Hong, Subeen Park, In Yang Park, Joong Shin Trials Study Protocol BACKGROUND: Cleansing of the vulva and perineum is recommended during preparation for vaginal delivery, and special attention is paid to cleansing before episiotomy because episiotomy is known to increase the risk of perineal wound infection and/or dehiscence. However, the optimal method of perineal cleansing has not been established, including the choice of antiseptic agent. To address this issue, we designed a randomized controlled trial to examine whether skin preparation with chlorhexidine-alcohol is superior to povidone-iodine for the prevention of perineal wound infection after vaginal delivery. METHODS: In this multicenter randomized controlled trial, term pregnant women who plan to deliver vaginally after episiotomy will be enrolled. The participants will be randomly assigned to use antiseptic agents for perineal cleansing (povidone-iodine or chlorhexidine-alcohol). The primary outcome is superficial or deep perineal wound infection within 30 days after vaginal delivery. The secondary outcomes are the length of hospital stay, physician office visits, or hospital readmission for infection-related complications, endometritis, skin irritations, and allergic reactions. DISCUSSION: This study will be the first randomized controlled trial aiming to determine the optimal antiseptic agent for the prevention of perineal wound infections after vaginal delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT05122169. First submitted date on 8 November 2021. First posted date on 16 November 2021 BioMed Central 2023-02-21 /pmc/articles/PMC9942633/ /pubmed/36810189 http://dx.doi.org/10.1186/s13063-023-07101-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Jung, Young Mi Lee, Seung Mi Kim, So Yeon Chung, Jin Hoon Won, Hye-Sung Lee, Kyung A Park, Mi Hye Cho, Geum Joon Oh, Min-Jeong Choi, Eun Saem Ahn, Ki Hoon Hong, Soon-Cheol Sung, Ji-Hee Roh, Cheong-Rae Kim, Sun Min Kim, Byoung Jae Kim, Hyeon Ji Oh, Kyung Joon Hong, Subeen Park, In Yang Park, Joong Shin The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial |
title | The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial |
title_full | The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial |
title_fullStr | The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial |
title_full_unstemmed | The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial |
title_short | The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial |
title_sort | skin antiseptic agents at vaginal delivery (save) trial: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942633/ https://www.ncbi.nlm.nih.gov/pubmed/36810189 http://dx.doi.org/10.1186/s13063-023-07101-w |
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