Lancet Infect Dis. 2022 Aug;22(8):1242-1251. doi: 10.1016/S1473-3099(22)00133-5. Epub 2022 May 26.
WHO and the UK's National Institute for Health and Care Excellence recommend alcoholic chlorhexidine skin preparation and triclosan-coated sutures to prevent surgical site infections (SSIs). Existing meta-analyses that include studies at high risk of bias, combined with the recent publication of large, randomised trials, justify an updated meta-analysis of high-quality randomised controlled trials (RCTs). We aimed to test the rates of SSI according to skin preparation solutions (ie, alcoholic chlorhexidine vs aqueous povidone-iodine) and types of sutures (ie, coated vs uncoated).
In this systematic review and meta-analysis, we searched MEDLINE, Embase, Pubmed, and Cochrane Library databases, with no language restrictions, to identify high-quality RCTs testing either alcoholic chlorhexidine skin preparation (vs aqueous povidone-iodine) or triclosan-coated sutures (vs uncoated sutures), or both, published from database inception to Sept 1, 2021. Patients who received clean-contaminated, contaminated, or dirty surgery were included. We predefined the characteristics of a high-quality trial through an expert consensus process to develop an enhanced Cochrane risk of bias-2 tool specifically for RCTs with a primary outcome of SSI. Data were extracted from published reports. Meta-analysis was performed using a random-effects model and heterogeneity was assessed using the I statistic. This systematic review and meta-analysis was prospectively registered in PROSPERO, CRD42021267220.
Of 942 studies identified, 933 were excluded. Four high-quality RCTs (n=7467 patients) were included that tested alcoholic chlorhexidine. No significant difference in SSI rates was noted between alcoholic chlorhexidine and aqueous povidone-iodine (17·9% [667 of 3723 patients] vs 19·8% [740 of 3744 patients]; odds ratio 0·84 [95% CI 0·65-1·06]; p=0·21, I=53·1%). Five high-quality RCTs were included that tested triclosan-coated sutures (n=8619 patients), with no significant difference noted between triclosan-coated and uncoated sutures (16·8% [733 of 4360 patients] vs 18·4% [784 of 4259 patients]; OR 0·90 [95% CI 0·74-1·09]; p=0·29, I=36·4%).
Contrary to previous meta-analyses, this study did not show a benefit from either alcoholic chlorhexidine skin preparation or triclosan-coated sutures, both of which are more expensive than other readily available alternatives. Global and national guidance should be reconsidered to remove recommendations for their routine use.
National Institute for Health Research (NIHR) Global Health Research Unit.
世界卫生组织(WHO)和英国国家卫生与保健优化研究所(National Institute for Health and Care Excellence)推荐使用含酒精的洗必泰皮肤消毒剂和三氯生涂层缝线来预防手术部位感染(SSI)。现有的荟萃分析纳入了存在高偏倚风险的研究,加上最近发表的大型随机试验,有理由对高质量随机对照试验(RCT)进行更新的荟萃分析。我们旨在根据皮肤准备溶液(即含酒精的洗必泰与聚维酮碘水溶液)和缝线类型(即涂层缝线与未涂层缝线)来测试 SSI 的发生率。
在这项系统评价和荟萃分析中,我们检索了 MEDLINE、Embase、PubMed 和 Cochrane 图书馆数据库,无语言限制,以确定从数据库建立到 2021 年 9 月 1 日发表的测试含酒精洗必泰皮肤准备(与聚维酮碘水溶液相比)或三氯生涂层缝线(与未涂层缝线相比)或两者均测试的高质量 RCT。纳入接受清洁污染、污染或污染手术的患者。我们通过专家共识过程预先确定了高质量试验的特征,专门为 SSI 主要结局的 RCT 开发了一个增强版 Cochrane 偏倚风险 2 工具。从已发表的报告中提取数据。使用随机效应模型进行荟萃分析,并使用 I 统计量评估异质性。本系统评价和荟萃分析在 PROSPERO 中进行,CRD42021267220。
在确定的 942 项研究中,有 933 项被排除。纳入了 4 项高质量 RCT(n=7467 例患者),这些 RCT 测试了含酒精的洗必泰。含酒精的洗必泰和聚维酮碘水溶液之间的 SSI 发生率无显著差异(17.9%[667/3723 例] vs 19.8%[740/3744 例];比值比 0.84[95%CI 0.65-1.06];p=0.21,I=53.1%)。纳入了 5 项高质量 RCT(n=8619 例患者),测试了三氯生涂层缝线,三氯生涂层缝线与未涂层缝线之间无显著差异(16.8%[733/4360 例] vs 18.4%[784/4259 例];OR 0.90[95%CI 0.74-1.09];p=0.29,I=36.4%)。
与之前的荟萃分析相反,本研究没有显示含酒精的洗必泰皮肤准备或三氯生涂层缝线有任何益处,这两种方法都比其他现成的替代品更昂贵。全球和国家的指导方针应该重新考虑,以取消对其常规使用的建议。
英国国家卫生与保健优化研究所(NIHR)全球卫生研究单位。