Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: Study protocol for a multicentre, single-blind, randomised controlled clinical trial

Masashi Takeuchi, Hideaki Obara, Hirofumi Kawakubo, Masahiro Shinoda, Koji Okabayashi, Shuhei Mayanagi, Tomoyuki Irino, Kazumasa Fukuda, Rieko Nakamura, Norihito Wada, Minoru Kitago, Hiroshi Yagi, Yuta Abe, Go Oshima, Shutaro Hori, Masashi Tsuruta, Takashi Ishida, Takahiro Yokose, Kazuya Hirukawa, Yoh IsobeYasuhito Sekimoto, Hirohisa Harada, Yusuke Maeda, Masaya Shito, Takayuki Kondo, Yasunori Sato, Yuukou Kitagawa

Research output: Contribution to journalArticle

Abstract

Introduction: The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. Methods and analysis: We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. Ethics and dissemination: The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals.

Original languageEnglish
Article numbere028269
JournalBMJ open
Volume9
Issue number5
DOIs
Publication statusPublished - 2019 May 1

Fingerprint

Povidone-Iodine
Surgical Wound Infection
Local Anti-Infective Agents
Randomized Controlled Trials
Research Ethics Committees
Japan
Chlorhexidine
Gram-Positive Bacteria
Gram-Negative Bacteria
Ethics
Odds Ratio
Medicine
Outcome Assessment (Health Care)
Guidelines
Skin
olanexidine
Therapeutics
Pharmaceutical Preparations

Keywords

  • gastrointestinal infections
  • surgery
  • wound management

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery : Study protocol for a multicentre, single-blind, randomised controlled clinical trial. / Takeuchi, Masashi; Obara, Hideaki; Kawakubo, Hirofumi; Shinoda, Masahiro; Okabayashi, Koji; Mayanagi, Shuhei; Irino, Tomoyuki; Fukuda, Kazumasa; Nakamura, Rieko; Wada, Norihito; Kitago, Minoru; Yagi, Hiroshi; Abe, Yuta; Oshima, Go; Hori, Shutaro; Tsuruta, Masashi; Ishida, Takashi; Yokose, Takahiro; Hirukawa, Kazuya; Isobe, Yoh; Sekimoto, Yasuhito; Harada, Hirohisa; Maeda, Yusuke; Shito, Masaya; Kondo, Takayuki; Sato, Yasunori; Kitagawa, Yuukou.

In: BMJ open, Vol. 9, No. 5, e028269, 01.05.2019.

Research output: Contribution to journalArticle

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abstract = "Introduction: The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5{\%} olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. Methods and analysis: We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5{\%} olanexidine or 10{\%} povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95{\%} CI will be estimated using the Mantel-Haenszel method. Ethics and dissemination: The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals.",
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T2 - Study protocol for a multicentre, single-blind, randomised controlled clinical trial

AU - Takeuchi, Masashi

AU - Obara, Hideaki

AU - Kawakubo, Hirofumi

AU - Shinoda, Masahiro

AU - Okabayashi, Koji

AU - Mayanagi, Shuhei

AU - Irino, Tomoyuki

AU - Fukuda, Kazumasa

AU - Nakamura, Rieko

AU - Wada, Norihito

AU - Kitago, Minoru

AU - Yagi, Hiroshi

AU - Abe, Yuta

AU - Oshima, Go

AU - Hori, Shutaro

AU - Tsuruta, Masashi

AU - Ishida, Takashi

AU - Yokose, Takahiro

AU - Hirukawa, Kazuya

AU - Isobe, Yoh

AU - Sekimoto, Yasuhito

AU - Harada, Hirohisa

AU - Maeda, Yusuke

AU - Shito, Masaya

AU - Kondo, Takayuki

AU - Sato, Yasunori

AU - Kitagawa, Yuukou

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N2 - Introduction: The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. Methods and analysis: We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. Ethics and dissemination: The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals.

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