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Randomized Controlled Trial
. 2024 Dec;50(12):2114-2124.
doi: 10.1007/s00134-024-07693-0. Epub 2024 Nov 12.

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

Matthieu Boisson  1 , Géraldine Allain  2 , Jean-Christian Roussel  3 , Nicolas d'Ostrevy  4 , Silvia Burbassi  5 , Pierre Demondion  6 , Paul-Michel Mertes  7 , François Labaste  8 , Thomas Kerforne  9 , Bertrand Rozec  10 , Vedat Eljezi  11 , Konstantinos Zannis  12 , Pascal Leprince  6 , Walid Oulehri  13 , Vincent Minville  8 , Sabrina Seguin  14 , Ambre Loiodice  15 , Stéphane Ruckly  16 , Jean-Christophe Lucet  17 , Jean-François Timsit  18   19 , Olivier Mimoz  20 ; CLEAN 2 Study Group
Affiliations
Randomized Controlled Trial

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

Matthieu Boisson et al. Intensive Care Med. 2024 Dec.

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.

Keywords: Cardiac surgery; Chlorhexidine; Povidone iodine; Skin antisepsis; Surgical site infection.

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Conflict of interest statement

Declarations. Conflicts of interest: MB reports grants from Becton Dickinson; consulting fees from Becton Dickinson and Edwards LifesSciences; honoraria for lectures from Becton Dickinson; and payment for participation on an advisory board for Becton Dickinson and Edwards LifesSciences. BR reports grants from Aguettant and i-SEP; consulting fees from LFB, Aguettant and Nordic Pharma; and attending meetings or travel from i-SEP. JFT reports grants from MSD and Pfizer; honoraria for lectures from Becton Dickinson and Shionogi; and payment for participation on an advisory board for MSD, Pfizer, Gilead, Advanz, Roche and Becton Dickinson. OM reports grants from 3 M and Becton Dickinson; consulting fees from 3 M and Becton Dickinson; honoraria for lectures from 3 M and Becton Dickinson; support for attending meetings or travel from 3 M and Becton Dickinson; and payment for participation on an advisory board for 3 M and Becton Dickinson. All other authors declare no competing interests. Role of the funder: The funders had no role in the design or execution of the trial, data analysis, or writing or reviewing of the manuscript. Data sharing: Data collected for the study, including participant data, the data dictionary defining each field in the set, and the study protocol, will be made available to others. Data will be communicated as de-identified participant data according to French law, and will be available after publication of the manuscript. Data will be made available at the Direction de la Recherche, Poitiers University Hospital, Poitiers, France (drci@chu-poitiers.fr), with investigator support, after approval of a proposal with a signed data access agreement.

Figures

Fig. 1
Fig. 1
Consort flow diagram
Fig. 2
Fig. 2
Cumulative incidence curve. No risk of local infection between days 30 and 90 was considered in the event of reoperation on the saphenous vein/radial artery site. The cumulative incidence curve was derived using 1 minus the survival function obtained from the Kaplan–Meier method. The p-value was obtained from a log-rank test comparing the survival curves
See this image and copyright information in PMC

References

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