Abstract | 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.
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Authors | Akira Umemura, Akira Sasaki, Hisataka Fujiwara, Kazuho Harada, Satoshi Amano, Naoto Takahashi, Yota Tanahashi, Takayuki Suto |
Journal | Annals of gastroenterological surgery
(Ann Gastroenterol Surg)
Vol. 7
Issue 5
Pg. 819-831
(Sep 2023)
ISSN: 2475-0328 [Electronic] Japan |
PMID | 37663968
(Publication Type: Journal Article)
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Copyright | © 2023 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterological Surgery. |