Aim: Surgical site infection (SSI) is one of the most common postoperative complications in gastrointestinal surgery. To clarify the superiority of 1.5% olanexidine, we conducted a randomized prospective clinical trial that enrolled patients undergoing gastrointestinal surgery with operative wound classes II-IV.
Methods: To evaluate the efficacy of 1.5% olanexidine in preventing SSIs relative to 10% povidone-iodine, we enrolled 298 patients in each group. The primary outcome was a 30-day SSI, and the secondary outcomes were incidences of superficial and deep incisional SSI and organ/space SSI. In addition, subgroup analyses were performed.
Results: The primary outcome of the overall 30-day SSI occurred in 38 cases (12.8%) in the 1.5% olanexidine group and in 53 cases (18.0%) in the 10% povidone-iodine group (adjusted risk ratio: 0.716, 95% confidence interval: 0.495-1.057, p = 0.083). Organ/space SSI occurred in 18 cases (6.1%) in the 1.5% olanexidine group and in 31 cases (10.5%) in the 10% povidone-iodine group, with a significant difference (adjusted risk ratio: 0.587, 95% confidence interval: 0.336-0.992, p = 0.049). Subgroup analyses revealed that SSI incidences were comparable in scheduled surgery (relative risk: 0.809, 95% confidence interval: 0.522-1.254) and operative wound class II (relative risk: 0.756, 95% confidence interval: 0.494-1.449) in 1.5% olanexidine group.
Conclusion: Our study revealed that 1.5% olanexidine reduced the 30-day overall SSI; however, the result was not significant. Organ/space SSI significantly decreased in the 1.5% olanexidine group. Our results indicate that 1.5% olanexidine has the potential to prevent SSI on behalf of povidone-iodine.
Keywords: antiseptic; olanexidine; povidone‐iodine; randomized clinical trial; surgical site infection.
© 2023 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterological Surgery.