The British journal of surgery · 2025
Efficacy 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.
Сравнительное исследованиеEquivalence TrialСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Takeuchi Masashi, Obara Hideaki, Furube Tasuku, Kawakubo Hirofumi, Kitago Minoru, Okabayashi Koji, Fujisaki Hiroto, Aoyama Junya, Morimoto Yosuke, Amemiya Ryusuke, Sano Junichi, Nakadai Jumpei, Goto Rei, Sato Yasunori, Kitagawa Yuko
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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)).
CONCLUSION: 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.
REGISTRATION NUMBER: UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).
METHODS: 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.
RESULTS: 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)).
CONCLUSION: 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.
REGISTRATION NUMBER: UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).