Intraoperative wound irrigation to prevent surgical site infection after laparotomy: IOWISI
Final Report Abstract
Patients undergoing laparotomy for visceral resections are at medium to high risk for postoperative surgical site infections, depending on the level of intraoperative bacterial contamination. Not only do surgical site infections pose a significant threat to the patients’ health, but they also impede further essential treatments such as adjuvant chemotherapy. Therefore, effective measures to prevent such infections are urgently required. Antiseptic irrigation of the surgical wound at the end of surgery appears to be a promising and simple measure, which had never been evaluated in a large randomized clinical trial before. Hence, we conducted a three-armed, multi-centre, randomized, controlled, patient and observer blinded clinical trial to investigate whether the intraoperative wound irrigation with Polyhexanide 0.04% solution is superior to the irrigation with simple saline or no irrigation in the prevention of surgical site infections after laparotomy for any reason but at least level of contamination II. Between 2017 and 2022, 689 patients were recruited in 12 study sites across Germany. The majority (>90%) of patients underwent elective surgical procedures with a low level of bacterial wound contamination II (60% hepatobiliary/pancreatic, 19% colorectal, 18% upper gastrointestinal procedures). The overall rate of surgical site infections in the study population was 11.8%. Antiseptic wound irrigation with Polyhexanide 0.04% was not able to reduce this rate compared to saline irrigation or no irrigation following these procedures. However, this result is an important step forward in understanding the adequacy of intraoperative wound irrigation to prevent surgical site infections. Regarding secondary endpoints and safety analysis, the IOWISI trial showed no harms or negative effects of Polyhexanide wound irrigation. Future clinical trials should focus on procedures with a higher postoperative infection risk due to intraoperative bacterial contamination level III (gross spillage or uncontrolled opening of the gastrointestinal tract) or IV (emergency laparotomy with pre-existing peritonitis), as antiseptic wound irrigation might still be beneficial here.
Publications
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Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbeck's Archives of Surgery, 400(2), 167-181.
Mueller, Tara C.; Loos, Martin; Haller, Bernhard; Mihaljevic, André L.; Nitsche, Ulrich; Wilhelm, Dirk; Friess, Helmut; Kleeff, Jörg & Bader, Franz G.
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Intraoperative wound irrigation to prevent surgical site infection after laparotomy (IOWISI): study protocol for a randomized controlled trial. Trials, 18(1).
Mueller, Tara C.; Nitsche, Ulrich; Kehl, Victoria; Schirren, Rebekka; Schossow, Beate; Goess, Ruediger; Friess, Helmut & Reim, Daniel
