本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2307679

摘要内容如下：

背景

关于在修复骨折肢体（即四肢骨折）手术前使用含碘Povacrylex或葡萄糖酸氯己定的酒精溶液作为皮肤防腐剂，评估手术部位感染的研究结果相互矛盾。

方法

在美国和加拿大的25家医院进行的一项整群随机交叉试验中，我们将医院随机分为两组，一组使用0.7%碘Povacrylex在74%异丙醇中的溶液（碘组），另一组使用2%葡萄糖酸氯己定在70%异丙醇中的溶液（氯己定组），作为四肢骨折修复手术的术前消毒。每两个月，医院交替干预。开放性或闭合性骨折患者的单独人群被纳入分析。主要结果是手术部位感染，包括30天内的浅表切口感染或90天内的深部切口或器官间隙感染。次要结果是骨折愈合并发症的非计划性再手术。

结果

共有6785名闭合性骨折患者和1700名开放性骨折患者被纳入试验。在闭合性骨折人群中，碘组中有77名患者（2.4%）发生手术部位感染，洗必泰组中有108名患者（3.3%）发生手术部位感染（比值比为0.74；95%置信区间[CI]，0.55至1.00；P=0.049）。在开放性骨折人群中，碘组有54名患者（6.5%）发生手术部位感染，洗必泰组有60名患者（7.3%）发生手术部位感染（比值比为0.86；95%可信区间为0.58~1.27；P=0.45）。两组的非计划性再手术、1年结果和严重不良事件的发生率相似。

结论

在闭合性四肢骨折的患者中，用碘伏酒精消毒皮肤比用葡萄糖酸氯己定酒精消毒导致的手术部位感染更少。在开放性骨折患者中，两组的结果相似。（由以患者为中心的结果研究所（Patient-Centered Outcomes Research Institute）和加拿大卫生研究所（Canadian Institutes of Health Research）资助；Prepare ClinicalTrials.gov，NCT03523962）。

英文原文如下：

Abstracts

BACKGROUND  Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).

METHODS  In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.

RESULTS  A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.

CONCLUSIONS  Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

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