Intraoperative Wound Irrigation for the Prevention of Surgical Site Infection after Laparotomy: A Randomized Clinical Trial by CHIR-Net

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Tara Catharina Mueller - , Technical University of Munich (Author)
  • Victoria Kehl - , Technical University of Munich (Author)
  • Rebekka Dimpel - , Technical University of Munich (Author)
  • Christiane Blankenstein - , Technical University of Munich (Author)
  • Silvia Egert-Schwender - , Technical University of Munich (Author)
  • Judith Strudthoff - , Technical University of Munich (Author)
  • Johan Friso Lock - , University of Würzburg (Author)
  • Armin Wiegering - , University of Würzburg (Author)
  • Ali Hadian - , University Medical Center Mainz (Author)
  • Hauke Lang - , University Medical Center Mainz (Author)
  • Markus Albertsmeier - , Ludwig Maximilian University of Munich (Author)
  • Michael Neuberger - , Ludwig Maximilian University of Munich (Author)
  • Viktor Von Ehrlich-Treuenstätt - , Ludwig Maximilian University of Munich (Author)
  • André L. Mihaljevic - , Heidelberg University  (Author)
  • Phillip Knebel - , Heidelberg University  (Author)
  • Frank Pianka - , Heidelberg University  (Author)
  • Chris Braumann - , Ruhr University Bochum (Author)
  • Waldemar Uhl - , Ruhr University Bochum (Author)
  • Ralf Bouchard - , Universitätsklinikum Schleswig-Holstein - Campus Lübeck (Author)
  • Ekaterina Petrova - , Universitätsklinikum Schleswig-Holstein - Campus Lübeck (Author)
  • Ulrich Bork - , Department of Visceral, Thoracic and Vascular Surgery, National Center for Tumor Diseases (Partners: UKD, MFD, HZDR, DKFZ), University Hospital Carl Gustav Carus Dresden, German Cancer Research Center (DKFZ) (Author)
  • Marius Distler - , Department of Visceral, Thoracic and Vascular Surgery, National Center for Tumor Diseases (Partners: UKD, MFD, HZDR, DKFZ), University Hospital Carl Gustav Carus Dresden, German Cancer Research Center (DKFZ) (Author)
  • Michael Tachezy - , University of Hamburg (Author)
  • Jakob R. Izbicki - , University of Hamburg (Author)
  • Christoph Reissfelder - , Heidelberg University  (Author)
  • Florian Herrle - , Heidelberg University  (Author)
  • Christian Vay - , Heinrich Heine University Düsseldorf (Author)
  • Wolfram Trudo Knoefel - , Heinrich Heine University Düsseldorf (Author)
  • Alexander Buia - , Asklepios Clinic Seligenstadt (Author)
  • Ernst Hanisch - , Asklepios Clinic Seligenstadt (Author)
  • Helmut Friess - , Technical University of Munich (Author)
  • Daniel Reim - , Technical University of Munich (Author)

Abstract

Importance: Surgical site infections frequently occur after open abdominal surgery. Intraoperative wound irrigation as a preventive measure is a common practice worldwide, although evidence supporting this practice is lacking. Objective: To evaluate the preventive effect of intraoperative wound irrigation with polyhexanide solution. Design, Setting, and Participants: The Intraoperative Wound Irrigation to Prevent Surgical Site Infection After Laparotomy (IOWISI) trial was a multicenter, 3-armed, randomized clinical trial. Patients and outcome assessors were blinded to the intervention. The clinical trial was conducted in 12 university and general hospitals in Germany from September 2017 to December 2021 with 30-day follow-up. Adult patients undergoing laparotomy were eligible for inclusion. The main exclusion criteria were clean laparoscopic procedures and the inability to provide consent. Of 11700 screened, 689 were included and 557 completed the trial; 689 were included in the intention-to-treat and safety analysis. Interventions: Randomization was performed online (3:3:1 allocation) to polyhexanide 0.04%, saline, or no irrigation (control) of the operative wound before closure. Main Outcome and Measures: The primary end point was surgical site infection within 30 postoperative days according to the US Centers for Disease Control and Prevention definition. Results: Among the 689 patients included, 402 were male and 287 were female. The median (range) age was 65.9 (18.5-94.9) years. Participants were randomized to either wound irrigation with polyhexanide (n = 292), saline (n = 295), or no irrigation (n = 102). The procedures were classified as clean contaminated in 92 cases (8%). The surgical site infection incidence was 11.8% overall (81 of 689), 10.6% in the polyhexanide arm (31 of 292), 12.5% in the saline arm (37 of 295), and 12.8% in the no irrigation arm (13 of 102). Irrigation with polyhexanide was not statistically superior to no irrigation or saline irrigation (hazard ratio [HR], 1.23; 95% CI, 0.64-2.36 vs HR, 1.19; 95% CI, 0.74-1.94; P =.47). The incidence of serious adverse events did not differ among the 3 groups. Conclusions and Relevance: In this study, intraoperative wound irrigation with polyhexanide solution did not reduce surgical site infection incidence in clean-contaminated open abdominal surgical procedures compared to saline or no irrigation. More clinical trials are warranted to evaluate the potential benefit in contaminated and septic procedures, including the emergency setting. Trial Registration: drks.de Identifier: DRKS00012251.

Details

Original languageEnglish
Pages (from-to)484-492
Number of pages9
JournalJAMA surgery
Volume159
Issue number5
Publication statusPublished - 8 May 2024
Peer-reviewedYes

External IDs

PubMed 38381428

Keywords

ASJC Scopus subject areas

Keywords

  • Laparotomy/adverse effects, Biguanides/therapeutic use, Humans, Middle Aged, Intraoperative Care/methods, Male, Female, Adult, Aged, Surgical Wound Infection/prevention & control, Therapeutic Irrigation