Purpose

Whether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear.

Methods

CLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.

Results

Of 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90 days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), − 1.58–2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI − 0.55–2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups.

Conclusion

Among patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates.

中文翻译：

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氯己定-酒精与聚维酮-碘-酒精皮肤消毒方案在心脏大手术中的比较：一项随机临床试验

 目的

在减少心脏大手术后的再手术和手术部位感染率方面，使用洗必泰-酒精对手术部位进行皮肤消毒是否优于聚维酮-碘-醇仍不清楚。

 方法

CLEAN 2 是一项多中心、开放标签、随机、双臂、评估员盲法、优效性试验，在 8 家法国医院进行。我们随机分配了通过胸骨切开术接受心脏或主动脉大手术的成年患者，有或没有隐静脉或桡动脉收集，用 2% 洗必泰-酒精或 5% 聚维酮-碘-酒精对所有手术部位进行消毒。主要结局是第 90 天时胸骨切开术或第 30 天外周手术部位的任何再次手术。

 结果

在 3242 例患者中（洗必泰醇组 1621 例 [中位年龄 69 岁;男性 1276 例 （78.7%） ]和聚维酮碘醇组 1621 例 [中位年龄 69 岁;1247 例 （76.9%） 男性]中，90 天内需要再次手术的百分比相似（洗必泰醇组为 7.7% [125/1621] vs 聚维酮碘醇组为 7.5% [121/1621];风险差，0.25 [95% 置信区间 （CI）， − 1.58–2.07]，P = 0.79）。胸骨或外周部位手术部位感染的发生率相似（洗必泰-醇组为 4% [65/1621]，聚维酮-碘-醇组为 3.3% [53/1621];风险差，0.74 [95% CI − 0.55-2.03]，P = 0.26）。两组患者的住院时间、重症监护病房或再入院率、死亡率和手术部位不良事件相似。

 结论

在需要胸骨切开术进行心脏或主动脉大手术的患者中，使用洗必泰-酒精在手术部位进行皮肤消毒在降低再次手术和手术部位感染率方面并不优于聚维酮-碘-醇。