Abstract
Background
This study evaluated the microbiological effectiveness and organizational impact of waterless perineal hygiene compared with traditional soap-and-water cleansing in fully dependent hospitalized patients, addressing a gap in evidence within acute care settings.Methods
This multicenter, randomized, open-label superiority trial was conducted in 10 medical and geriatric wards across four hospitals in Northern Italy. Fully dependent adult inpatients were randomized 1:1 to waterless hygiene or standard soap-and-water care. The primary outcome was the proportion of participants achieving a ≥90% reduction in microbial load between pre- and post-procedure perineal swabs. Secondary outcomes included procedure duration, patient and healthcare professional satisfaction, and agreement between evaluations.Results
A total of 468 participants were analyzed (239 control; 229 experimental). The experimental procedure achieved a higher proportion of ≥90% microbial reduction compared with standard care (47.2% vs 37.2%; p=0.030), corresponding to an absolute risk difference of 9.9% (95% CI 1.0-18.8) and a risk ratio of 1.27 (95% CI 1.02-1.57). Procedure duration was similar between groups (median 10 vs 11 minutes; p=0.311). Satisfaction was high in both groups, with more favorable perceptions of fragrance and overall hygiene in the experimental group.Conclusions
Waterless perineal hygiene demonstrated greater immediate microbiological cleansing effectiveness than standard soap-and-water hygiene without increasing procedure time. Further studies are needed to determine whether these microbiological findings translate into improved clinical outcomes, including healthcare-associated infections.