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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
  1. Masashi Takeuchi1,
  2. Hideaki Obara1,
  3. Hirofumi Kawakubo1,
  4. Masahiro Shinoda1,
  5. Koji Okabayashi1,
  6. Shuhei Mayanagi1,
  7. Tomoyuki Irino1,
  8. Kazumasa Fukuda1,
  9. Rieko Nakamura1,
  10. Norihito Wada1,
  11. Minoru Kitago1,
  12. Hiroshi Yagi1,
  13. Yuta Abe1,
  14. Go Oshima1,
  15. Shutaro Hori1,
  16. Masashi Tsuruta1,
  17. Takashi Ishida1,
  18. Takahiro Yokose1,
  19. Kazuya Hirukawa1,
  20. Yoh Isobe2,
  21. Yasuhito Sekimoto2,
  22. Hirohisa Harada3,
  23. Yusuke Maeda3,
  24. Masaya Shito4,
  25. Takayuki Kondo4,
  26. Yasunori Sato5,
  27. Yuko Kitagawa1
  1. 1Department of Surgery, Keio University School of Medicine, Tokyo, Japan
  2. 2Department of Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan
  3. 3Department of Surgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan
  4. 4Department of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan
  5. 5Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan
  1. Correspondence to Dr Hideaki Obara; obara.z3{at}


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.

Trial registration number UMIN 000031560; Pre-results.

  • wound management
  • surgery
  • gastrointestinal infections

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  • Contributors MT and HO contributed equally to this study. All authors made significant contribution to the conception and design of the study protocol. MT designed the study and wrote the protocol and manuscript. SM, TI, KF, RN, NW, MK, HY, YA, GO, SH, MT, TI, TY, KH, YI, YS, HH, YM, MS and TK assisted with the development of the study design and protocol. The protocol was reviewed by HO, HK, MS, KO and YK. YS wrote the statistical analysis plan. All authors gave final approval of the manuscript and agree to be accountable for all aspects of the work.

  • Funding This work was supported by donations from the Department of Surgery, Keio University School of Medicine and Ohyama Health Foundation Inc.

  • Disclaimer Otsuka Pharmaceutical Factory Inc. was not involved in the planning of the protocol or in the conduct of the trial.

  • Competing interests YK received grant support from Otsuka Pharmaceutical Factory Inc.

  • Ethics approval The protocol was first approved by the Institutional Review Board of Keio University School of Medicine and then approved by the institutional review board of each participating site.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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