A cluster-randomized, crossover trial conducted at 25 hospitals in the United States and Canada aimed to address the conflicting findings in studies regarding the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate for skin antisepsis before surgical procedures to repair extremity fractures.
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Povacrylex
The trial assigned hospitals to use either 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis, with interventions alternating every 2 months.
The study enrolled 6785 patients with closed fractures and 1700 patients with open fractures, analyzing surgical-site infection as the primary outcome, including superficial incisional infection within 30 days and deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.
In the closed-fracture population, the iodine group exhibited a lower incidence of surgical-site infection at 2.4%, compared to 3.3% in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). Conversely, in the open-fracture population, surgical-site infection rates were 6.5% in the iodine group and 7.3% in the chlorhexidine group (odds ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events demonstrated similarity between the two groups.
The trial’s findings suggest a potential benefit of using the iodine povacrylex solution over chlorhexidine gluconate for closed fractures, indicated by a lower surgical-site infection incidence. However, the difference in open fractures did not reach statistical significance. Importantly, the study revealed comparable outcomes in terms of unplanned reoperation, 1-year results, and adverse events between the two antiseptic solutions.
While the trial contributes valuable insights into preoperative skin antisepsis for extremity fracture repair, further research may be necessary to explore specific factors influencing the efficacy of each solution in different fracture scenarios. Nonetheless, this study provides a foundation for clinical decision-making regarding skin antisepsis strategies, particularly in the context of extremity fracture surgeries.
