Objective: We conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water, used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based handrub for surgical hand preparation in a rural hospital in
Methods: 3317 adult patients undergoing clean and clean-contaminated surgery were included in the study. Follow-up data 30 days post-discharge were available for 3133 (94%) patients. The main outcome measure was SSI rates. Multivariable modelling was performed by stepwise logistic regression analysis. To account for clustering effects, we used robust estimates of variance by considering each study period as a cluster (generalized estimating equation).
Results: A total of 255 (8.1%) patients developed SSI (75% superficial, 23% deep, 2% organ-space infections). The median interval to SSI diagnosis was 15 days (interquartile range, 9 – 23). Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33). After adjustment for imbalances between study arms (type of anesthesia, surgical specialty, ASA class, operating room assignment, perioperative prophylaxis) and clustering effects, the main outcome measure remained unchanged (adjusted OR, 1.07; 95% CI, 0.81 - 1.41). Duration of surgery and wound contamination class independently predicted SSI. The cost difference between plain soap and water and alcohol-based handrub was small (Euros 4.60 per week for alcohol-based handrub, compared to Euros 3.30 for soap and water).
Conclusions: There was no statistically or clinically significant difference in SSI rates between the two study arms, suggesting that other more important factors may contribute to SSI occurrence in this setting. Nevertheless, the study demonstrates the feasibility and affordability of surgical hand preparation using alcohol-based handrub in settings where the lack of a clean or continuous water supply is a potential threat for safe surgery.