CLEAN2
Trial question
What is the role of surgical site disinfection using chlorhexidine plus alcohol in patients requiring sternotomy for major heart or aortic surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 3242
3242 patients (719 female, 2523 male).
Inclusion criteria: adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting.
Key exclusion criteria: allergy to chlorhexidine, povidone-iodine, isopropanol, or ethanol; heart transplant surgery or thoracic infection; any signs of inflammation or sternal instability at the sternotomy site; history of cardiac surgery in the past 3 months.
Interventions
N=1621 chlorhexidine plus alcohol (surgical site disinfection using 26 mL single-use applicators of chlorhexidine plus alcohol).
N=1621 povidone-iodine plus alcohol (surgical site disinfection using sterile disposable sets and 500 mL bottles of povidone-iodine plus alcohol).
Primary outcome
Rate of resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30
7.7%
7.5%
7.7 %
5.8 %
3.9 %
1.9 %
0.0 %
Chlorhexidine plus
alcohol
Povidone-iodine plus
alcohol
No significant
difference ↔
No significant difference in the rate of resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30 (7.7% vs. 7.5%; RR 1.03, 95% CI 0.81 to 1.31).
Secondary outcomes
No significant difference in mediastinitis at day 90 (2.3% vs. 2.4%; RR 0.95, 95% CI 0.61 to 1.45).
No significant difference in sternal wound infection requiring surgery at day 90 (2.4% vs. 2.5%; RR 0.95, 95% CI 0.62 to 1.47).
No significant difference in death at day 90 (2.4% vs. 3.1%; RR 0.76, 95% CI 0.51 to 1.15).
Safety outcomes
No significant difference in adverse events related to antisepsis.
Conclusion
In adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, chlorhexidine plus alcohol was not superior to povidone-iodine plus alcohol with respect to the rate of resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.
Reference
Matthieu Boisson, Géraldine Allain, Jean-Christian Roussel et al. Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial. Intensive Care Med. 2024 Dec;50(12):2114-2124.
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