biostudies-literatureUnknown112(4)Takeuchi MDepartment of Surgery, Keio University School of Medicine<h4>Background</h4>Surgical-site antisepsis is used to prevent surgical-site infections (SSIs). Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine, povidone-iodine, and olanexidine, in reducing the SSI rate, an optimal recommendation is still not established. The aim of this study was to evaluate the efficacy of aqueous olanexidine compared with chlorhexidine-alcohol as the optimal antiseptic for preventing SSI in clean-contaminated surgery.<h4>Methods</h4>This multicentre randomized trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary-pancreatic surgeries in five hospitals evaluated the efficacy of olanexidine and chlorhexidine-alcohol. The primary endpoint was 30-day SSI. Secondary outcomes included the occurrence of SSI types, intervention-related toxicity, and reoperation caused by SSI.<h4>Results</h4>Overall, 700 patients from five institutions underwent randomization; 347 received olanexidine and 345 received chlorhexidine-alcohol in the full analysis set. The 30-day SSI rate was 12.4% (43 of 347) in the olanexidine group and 13.6% (47 of 345) in the chlorhexidine-alcohol group (adjusted risk ratio (aRR) 0.911 (95% c.i. 0.625 to 1.327); P = 0.626). No significant differences were observed between the groups regarding the secondary outcomes, including the occurrence of superficial incisional SSI, deep incisional SSI, organ/space SSI, and reoperation caused by SSI. Overall adverse effects were seen in two patients (0.58%) in the olanexidine group and in three patients (0.87%) in the chlorhexidine-alcohol group (aRR 0.663 (95% c.i. 0.111 to 3.951)).<h4>Conclusion</h4>Olanexidine did not significantly reduce the occurrence of overall SSI compared with chlorhexidine-alcohol. Nevertheless, these findings provide valuable insights for developing novel surgical SSI management protocols.<h4>Registration number</h4>UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).The British journal of surgeryznaf065https://www.ebi.ac.uk/biostudies/studies/S-EPMC12475902biostudies-literatureEfficacy of aqueous olanexidine compared with alcohol-based chlorhexidine for surgical skin antisepsis regarding the incidence of surgical-site infections in clean-contaminated surgery: a randomized superiority trial.PMC12475902Kitagawa YMorimoto YTakeuchi MOkabayashi KSato YFujisaki HGoto RKawakubo HAoyama JSano JObara HNakadai JAmemiya RFurube TKitago MfalseEfficacy of aqueous olanexidine compared with alcohol-based chlorhexidine for surgical skin antisepsis regarding the incidence of surgical-site infections in clean-contaminated surgery: a randomized superiority trial.<h4>Background</h4>Surgical-site antisepsis is used to prevent surgical-site infections (SSIs). Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine, povidone-iodine, and olanexidine, in reducing the SSI rate, an optimal recommendation is still not established. The aim of this study was to evaluate the efficacy of aqueous olanexidine compared with chlorhexidine-alcohol as the optimal antiseptic for preventing SSI in clean-contaminated surgery.<h4>Methods</h4>This multicentre randomized trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary-pancreatic surgeries in five hospitals evaluated the efficacy of olanexidine and chlorhexidine-alcohol. The primary endpoint was 30-day SSI. Secondary outcomes included the occurrence of SSI types, intervention-related toxicity, and reoperation caused by SSI.<h4>Results</h4>Overall, 700 patients from five institutions underwent randomization; 347 received olanexidine and 345 received chlorhexidine-alcohol in the full analysis set. The 30-day SSI rate was 12.4% (43 of 347) in the olanexidine group and 13.6% (47 of 345) in the chlorhexidine-alcohol group (adjusted risk ratio (aRR) 0.911 (95% c.i. 0.625 to 1.327); P = 0.626). No significant differences were observed between the groups regarding the secondary outcomes, including the occurrence of superficial incisional SSI, deep incisional SSI, organ/space SSI, and reoperation caused by SSI. Overall adverse effects were seen in two patients (0.58%) in the olanexidine group and in three patients (0.87%) in the chlorhexidine-alcohol group (aRR 0.663 (95% c.i. 0.111 to 3.951)).<h4>Conclusion</h4>Olanexidine did not significantly reduce the occurrence of overall SSI compared with chlorhexidine-alcohol. Nevertheless, these findings provide valuable insights for developing novel surgical SSI management protocols.<h4>Registration number</h4>UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).2025-01-01T00:00:00Z2025 Mar2026-05-03T03:14:16.147Z2026-05-03T03:11:28.393ZS-EPMC124759024015689210.1093/bjs/znaf065