Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Department of Surgery, Keio University School of Medicine, Tokyo, Japan
BMJ Open. 2023 Aug 21;13(8):e074169. doi: 10.1136/bmjopen-2023-074169.
Surgical site infections (SSIs) are among the most common nosocomial infections in surgery patients. Two types of preparations, povidone-iodine and chlorhexidine-alcohol, are commonly used in preoperative antiseptic procedures worldwide. However, there are inconsistencies among international guideline recommendations concerning skin antiseptics. This trial aimed to evaluate the superiority of olanexidine, which reduced SSI rates more than povidone-iodine in our previous randomised trial, over chlorhexidine-alcohol in clean-contaminated surgery.
This multicentre randomised controlled clinical trial will compare two antiseptics (1.5% olanexidine and 1.0% chlorhexidine-alcohol) to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. On providing consent, patients aged <18 years will be included. The primary outcome will be the postoperative 30-day overall SSI rate, while the secondary outcomes will be the postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, positive bacterial wound culture rate, cultured bacterial strains, rates of intervention-related toxicity and allergic events (eg, erythema, pruritus, dermatitis and other symptoms of allergy around the region disinfected by the antiseptic during surgery), rate of reoperations due to SSI, medical economic effect indicators (based on health insurance claims) and hospital duration. The Mantel-Haenszel method will be used to estimate the adjusted risk ratio and its 95% CI for the primary analysis, which will compare the treatment effects.
The protocol was approved by the Institutional Review Board of Keio University School of Medicine and subsequently by the board of each participating site. Participant recruitment began in January 2023. The final results will be published in medical journals after international peer review.
UMIN000049712.
手术部位感染（SSI）是手术患者中最常见的医院获得性感染之一。聚维酮碘和氯己定-酒精这两种消毒剂在全球范围内广泛用于术前消毒程序。然而，国际指南建议在皮肤消毒剂方面存在不一致之处。本试验旨在评估奥来昔定优于聚维酮碘，因为在我们之前的随机试验中，奥来昔定降低了 SSI 发生率，与氯己定-酒精相比，奥来昔定在清洁污染手术中预防 SSI 的效果更好。
这是一项多中心随机对照临床试验，将比较两种消毒剂（1.5%奥来昔定和 1.0%氯己定-酒精）预防胃肠道清洁污染手术的术后 30 天总体 SSI 发生率。在获得同意后，年龄<18 岁的患者将被纳入。主要结局是术后 30 天的总体 SSI 发生率，次要结局是术后 30 天的浅表切口 SSI 发生率、深部切口 SSI 发生率、器官/腔隙 SSI 发生率、阳性细菌伤口培养率、培养的细菌菌株、与干预相关的毒性和过敏事件（例如，手术期间消毒剂消毒区域的红斑、瘙痒、皮炎和其他过敏症状）发生率、因 SSI 再次手术的发生率、医疗经济效果指标（基于医疗保险索赔）和住院时间。将使用 Mantel-Haenszel 方法估计主要分析的调整风险比及其 95%置信区间，以比较治疗效果。
该方案已获得庆应义塾大学医学院机构审查委员会的批准，并随后获得每个参与地点的委员会的批准。参与者招募于 2023 年 1 月开始。最终结果将在国际同行评审后发表在医学期刊上。
UMIN000049712。
