Efficacy of aqueous olanexidine compared with alcohol-based chlorhexidine for surgical skin antisepsis regarding the incidence of surgical-site infections in clean-contaminated surgery: a randomized superiority trial.
Summary
In five-center randomized clean-contaminated surgeries (n=700), aqueous olanexidine did not reduce 30-day SSIs versus chlorhexidine–alcohol (12.4% vs 13.6%; aRR 0.911; P=0.626). Adverse events were rare and comparable; no differences were seen across SSI subtypes or reoperation.
Key Findings
- 30-day SSI incidence: 12.4% (olanexidine) vs 13.6% (chlorhexidine–alcohol); aRR 0.911; P=0.626
- No significant differences in superficial, deep, or organ/space SSIs, or reoperation due to SSI
- Adverse effects were rare and similar between groups (0.58% vs 0.87%)
Clinical Implications
For clean-contaminated procedures, chlorhexidine–alcohol remains a sound standard; adopting aqueous olanexidine solely to reduce SSIs is not supported. Extrapolation to clean aesthetic procedures should be cautious but suggests no clear benefit for switching.
Why It Matters
High-quality negative RCT clarifies that aqueous olanexidine offers no superiority over chlorhexidine–alcohol, informing antisepsis selection and stewardship.
Limitations
- Conducted in clean-contaminated GI/HBP surgeries; generalizability to clean aesthetic surgery is uncertain
- Potential lack of blinding inherent to antiseptic comparisons
Future Directions
Head-to-head trials in clean surgeries, cost-effectiveness analyses, and microbiome/skin tolerability endpoints could refine antiseptic recommendations.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - Multicenter randomized controlled superiority trial
- Study Design
- OTHER