Superiority trial comparing intraoperative wound irrigation with aqueous 10% povidone–iodine to saline for the purpose of reducing surgical site infection after elective gastrointestinal surgery: study protocol for a randomised controlled trial
Masaaki Saito,
Ryo Maemoto,
Hiroshi Noda,
Kosuke Ichida,
Sawako Tamaki,
Rina Kanemitsu,
Erika Machida,
Nozomi Kikuchi,
Ryotaro Sakio,
Hidetoshi Aizawa,
Taro Fukui,
Nao Kakizawa,
Yuta Muto,
Masahiro Iseki,
Rintaro Fukuda,
Fumiaki Watanabe,
Takaharu Kato,
Shingo Tsujinaka,
Yasuyuki Miyakura,
Toshiki Rikiyama
Affiliations
Masaaki Saito
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Ryo Maemoto
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Hiroshi Noda
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Kosuke Ichida
Department of Surgery, Jichi Medical University, Saitama, Japan
Sawako Tamaki
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Rina Kanemitsu
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Erika Machida
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Nozomi Kikuchi
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Ryotaro Sakio
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Hidetoshi Aizawa
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Taro Fukui
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Nao Kakizawa
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Yuta Muto
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Masahiro Iseki
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Rintaro Fukuda
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Fumiaki Watanabe
Department of Thoracic Surgery, Mie Chuo Medical Center, Tsu, Japan
Takaharu Kato
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Shingo Tsujinaka
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Yasuyuki Miyakura
Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Toshiki Rikiyama
Jichi Ika University Saitama Medical Center, Saitama, Japan
Introduction Surgical site infection (SSI) is one of the most common complications after gastrointestinal surgery, with a reported incidence of approximately 10%–25%, which is higher than the rates after other types of surgery. Intraoperative wound irrigation (IOWI) is a simple intervention for SSI prevention, and recent studies have reported that IOWI with aqueous povidone–iodine (PVP-I) is significantly more effective at reducing the incidence of SSI than saline. However, the evidence level of previous trials evaluating the efficacy of aqueous PVP-I solution for preventing SSI has been low.Methods and analyses We propose a single-institute, prospective, randomised, blinded-endpoint trial to assess the superiority of IOWI with aqueous 10% PVP-I solution compared with normal saline for reducing SSI in clean-contaminated wounds after elective gastrointestinal surgery. In the study group, IOWI with 40 mL of aqueous 10% PVP-I solution is performed for 1 min before skin suture, and in the control group, IOWI with 100 mL of saline is performed for 1 min before skin suture. We hypothesise that IOWI with aqueous 10% PVP-I solution will achieve a 50% reduction in the incidence of SSIs. The target number of cases is set at 950. The primary outcome is the incidence of incisional SSI up to postoperative day 30 and will be analysed in the modified intention-to-treat set.Ethics and dissemination This trial was designed and is being conducted by Saitama Medical Center, Jichi Medical University, with approval from the Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University. Participant recruitment began in June 2019. The final results will be reported in international peer-reviewed journals immediately after trial completion.Trial registration number UMIN000036889.
