{"title":"水奥兰西定与醇基氯己定用于外科皮肤消毒对清洁污染手术中手术部位感染发生率的影响：一项随机优势试验","authors":"Masashi Takeuchi, Hideaki Obara, Tasuku Furube, Hirofumi Kawakubo, Minoru Kitago, Koji Okabayashi, Hiroto Fujisaki, Junya Aoyama, Yosuke Morimoto, Ryusuke Amemiya, Junichi Sano, Jumpei Nakadai, Rei Goto, Yasunori Sato, Yuko Kitagawa","doi":"10.1093/bjs/znaf065","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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)).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Registration number: </strong>UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 4","pages":""},"PeriodicalIF":8.6000,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Masashi Takeuchi, Hideaki Obara, Tasuku Furube, Hirofumi Kawakubo, Minoru Kitago, Koji Okabayashi, Hiroto Fujisaki, Junya Aoyama, Yosuke Morimoto, Ryusuke Amemiya, Junichi Sano, Jumpei Nakadai, Rei Goto, Yasunori Sato, Yuko Kitagawa\",\"doi\":\"10.1093/bjs/znaf065\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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)).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Registration number: </strong>UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).</p>\",\"PeriodicalId\":136,\"journal\":{\"name\":\"British Journal of Surgery\",\"volume\":\"112 4\",\"pages\":\"\"},\"PeriodicalIF\":8.6000,\"publicationDate\":\"2025-03-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British Journal of Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjs/znaf065\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjs/znaf065","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
摘要
背景：手术部位消毒用于预防手术部位感染（ssi）。虽然一些指南已经指出了防腐剂，如氯己定、聚维酮碘和奥烷西定在降低SSI发生率方面的功效，但仍未建立最佳推荐。本研究的目的是评价奥兰西定水溶液与氯己定-酒精作为清洁污染手术中预防SSI的最佳防腐剂的效果。方法：对5家医院清洁污染胃肠道和肝胆胰手术皮肤消毒的多中心随机试验，评价奥兰内定和氯己定醇的疗效。主要终点为30天SSI。次要结局包括SSI类型的发生、干预相关的毒性以及SSI引起的再手术。结果：总体而言，来自5个机构的700名患者接受了随机分组；在全部分析组中，347例接受奥拉内西定治疗，345例接受氯己定酒精治疗。奥烷西定组30天SSI发生率为12.4%（347例中的43例），氯己定-酒精组为13.6%（345例中的47例）(校正风险比（aRR） 0.911 (95% ci . 0.625 ~ 1.327)；P = 0.626)。在次要结局方面，包括浅表切口SSI、深切口SSI、脏器/间隙SSI的发生以及SSI引起的再手术，两组间无显著差异。奥拉西定组有2例患者（0.58%）出现总体不良反应，氯己定-酒精组有3例患者（0.87%）出现总体不良反应（aRR 0.663 (95% ci 0.111 ~ 3.951)）。结论：与氯己定-酒精相比，奥兰内西定没有显著降低总体SSI的发生。然而，这些发现为开发新的外科SSI治疗方案提供了有价值的见解。注册号：UMIN 000049712（大学医院医学信息网络临床试验注册）。
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.
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).
期刊介绍：
The British Journal of Surgery (BJS), incorporating the European Journal of Surgery, stands as Europe's leading peer-reviewed surgical journal. It serves as an invaluable platform for presenting high-quality clinical and laboratory-based research across a wide range of surgical topics. In addition to providing a comprehensive coverage of traditional surgical practices, BJS also showcases emerging areas in the field, such as minimally invasive therapy and interventional radiology.
While the journal appeals to general surgeons, it also holds relevance for specialty surgeons and professionals working in closely related fields. By presenting cutting-edge research and advancements, BJS aims to revolutionize the way surgical knowledge is shared and contribute to the ongoing progress of the surgical community.
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