Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial

IF 27.1 1区医学 Q1 CRITICAL CARE MEDICINE

Intensive Care Medicine Pub Date : 2024-11-12 DOI:10.1007/s00134-024-07693-0

Matthieu Boisson, Géraldine Allain, Jean-Christian Roussel, Nicolas d’Ostrevy, Silvia Burbassi, Pierre Demondion, Paul-Michel Mertes, François Labaste, Thomas Kerforne, Bertrand Rozec, Vedat Eljezi, Konstantinos Zannis, Pascal Leprince, Walid Oulehri, Vincent Minville, Sabrina Seguin, Ambre Loiodice, Stéphane Ruckly, Jean-Christophe Lucet, Jean-François Timsit, Olivier Mimoz

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Abstract

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.

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心脏大手术中氯己定-酒精与聚维酮-碘-酒精皮肤防腐方案的比较：随机临床试验

目的在降低心脏大手术后的再次手术率和手术部位感染率方面，使用氯己定酒精对手术部位进行皮肤消毒是否优于聚维酮碘酒精，目前仍不清楚。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，无论是否采集了隐静脉或桡动脉，所有手术部位均使用 2% 氯己定酒精或 5% 聚维酮碘酒精进行消毒。结果在 3242 名患者中（洗必泰酒精组 1621 人[中位年龄 69 岁；男性 1276 人（78.7%）]，聚维酮碘酒组 1621 人[中位年龄 69 岁；男性 1247 人（76.9%）]），使用 2% 洗必泰酒精或 5% 聚维酮碘酒消毒所有手术部位的患者所占比例分别为：1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%、1%。90天内需要再次手术的比例相似（洗必泰酒精组 7.7% [125/1621] vs 聚维酮碘酒组 7.5% [121/1621]；风险差异，0.25 [95% 置信区间 (CI)，- 1.58-2.07]，P = 0.79）。胸骨或外周部位的手术部位感染发生率相似（洗必泰酒精组为 4% [65/1621] ，聚维酮碘酒精组为 3.3% [53/1621]；风险差异为 0.74 [95% CI - 0.55-2.03]，P = 0.26）。结论在需要进行胸骨切开术的心脏或主动脉大手术患者中，使用洗必泰-酒精进行手术部位皮肤消毒在降低再次手术率和手术部位感染率方面并不优于聚维酮-碘-酒精。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Intensive Care Medicine 医学-危重病医学

CiteScore

51.50

自引率

2.80%

发文量

326

审稿时长

1 months

期刊介绍： Intensive Care Medicine is the premier publication platform fostering the communication and exchange of cutting-edge research and ideas within the field of intensive care medicine on a comprehensive scale. Catering to professionals involved in intensive medical care, including intensivists, medical specialists, nurses, and other healthcare professionals, ICM stands as the official journal of The European Society of Intensive Care Medicine. ICM is dedicated to advancing the understanding and practice of intensive care medicine among professionals in Europe and beyond. The journal provides a robust platform for disseminating current research findings and innovative ideas in intensive care medicine. Content published in Intensive Care Medicine encompasses a wide range, including review articles, original research papers, letters, reviews, debates, and more.