Alcohol-Based Versus Aqueous Skin Antisepsis Before Surgical Fixation of Open Fractures: A Combined Analysis of 2 Cluster-Randomized Crossover Trials.

Abstract

BACKGROUND Skin antisepsis remains a vital component in prophylaxis against surgical site infection (SSI); however, for open fractures, it is unclear whether alcohol-based or aqueous solutions should be preferred. The purpose of this study was to compare the use of alcohol-based and aqueous skin antisepsis solutions, using data from the 2 PREP-IT trials, with respect to the risks of SSI and unplanned reoperation following surgery for an open fracture. METHODS Individual patient data from the 2 cluster-randomized, crossover clinical trials were combined to create a single data set of patients undergoing surgery for an open fracture. A regression model was used to analyze the effects of an alcohol-based versus an aqueous solution, as well as for potential interaction with the use of chlorhexidine or iodine as the primary agent. The primary outcome was SSI within 90 days. RESULTS A total of 3,338 participants undergoing surgery for an open fracture were included in the final analysis, with 1,700 receiving an alcohol-based solution and 1,638 receiving an aqueous solution. Overall, the use of an alcohol-based skin antiseptic solution, compared with an aqueous solution, did not reduce the risk of SSI at 90 days (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.66 to 1.48; p = 0.95), or the risk of unplanned reoperation at 1 year (OR, 0.98; 95% CI, 0.75 to 1.28; p = 0.88). Planned subgroup analyses also found no significant difference in the risk of SSI or unplanned reoperation when participants were stratified by Gustilo-Anderson type, fracture location, or the primary ingredient of the skin preparation solution (chlorhexidine versus iodophor). CONCLUSIONS This analysis found no difference in the risk of SSI or reoperation when comparing alcohol-based and aqueous skin preparation solutions. Furthermore, this analysis demonstrated no harm with use of an alcohol-based solution for open fractures, and the PREPARE trial found that skin preparation with 0.7% iodine povacrylex in 74% isopropyl alcohol was associated with a reduced risk of SSI for closed fractures. Given these findings, surgeons may wish to consider streamlining their policy by treating all fractures with a single skin antiseptic, 0.7% iodine povacrylex in 74% isopropyl alcohol. LEVEL OF EVIDENCE Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.