PICASSo
Trial question
Is povidone iodine in alcohol noninferior to chlorhexidine gluconate in alcohol for preoperative skin antiseptic preparation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 3321
3321 patients (1107 female, 2214 male)
Inclusion criteria: patients undergoing cardiac or abdominal surgery
Key exclusion criteria: age < 18 years
Interventions
N=1570 povidone iodine (surgical site disinfected with povidone iodine in alcohol for a total exposure time of at least 3 minutes)
N=1751 chlorhexidine gluconate (surgical site disinfected with chlorhexidine gluconate in alcohol for a total exposure time of at least 3 minutes)
Primary outcome
Rate of surgical site infection within 30 days after abdominal surgery and within 1 year after cardiac surgery
5.1
5.5
5.5 %
4.1 %
2.8 %
1.4 %
0.0 %
Povidone
iodine
Chlorhexidine
gluconate
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of surgical site infection within 30 days after abdominal surgery and within 1 year after cardiac surgery (5.1% vs. 5.5%; RR 0.92, 95% CI 0.69 to 1.23)
Secondary outcomes
No significant difference in surgical site infection after cardiac surgery (4.2% vs. 3.3%; RR 1.26, 95% CI 0.82 to 1.94)
No significant difference in surgical site infection after abdominal surgery (6.8% vs. 9.9%; RR 0.69, 95% CI 0.46 to 1.02)
Conclusion
In patients undergoing cardiac or abdominal surgery, povidone iodine was noninferior to chlorhexidine gluconate with respect to the rate of surgical site infection within 30 days after abdominal surgery and within 1 year after cardiac surgery.
Reference
Andreas F Widmer, Andrew Atkinson, Stefan P Kuster et al. Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for Preoperative Skin Antisepsis: A Randomized Clinical Trial. JAMA. 2024 Jun 17:e248531. Online ahead of print.
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