Skin Antisepsis before Surgical Fixation of Extremity Fractures.
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PREP-IT Investigators, Sprague Sheila, Slobogean Gerard, Wells Jeffrey L, O'Hara Nathan N, Thabane Lehana, Mullins C Daniel, Harris Anthony D, Wood Amber, Viskontas Darius, Apostle Kelly L, O'Toole Robert V, Joshi Manjari, Johal Herman, Al-Asiri Jamal, Hymes Robert A, Gaski Greg E, Pilson Holly T, Carroll Eben A, Babcock Sharon, Halvorson Jason J, Romeo Nicholas M, Matson Christopher A, Higgins Thomas F, Marchand Lucas S, Bergin Patrick F, Morellato John, Van Demark Robert E, Potter G David, Gitajn I Leah, Chang Gerard, Phelps Kevin D, Kempton Laurence B, Karunakar Madhav, Jaeblon Todd, Demyanovich Haley K, Domes Christopher M, Kuhn Gabrielle R, Reilly Rachel M, Gage Mark J, Weaver Michael J, von Keudell Arvind G, Heng Marilyn, McTague Michael F, Alnasser Ahmad, Mehta Samir, Donegan Derek J, Natoli Roman M, Szatkowski Jan, Scott Alesha N, Shannon Steven F, Jeray Kyle J, Tanner Stephanie L, Marmor Meir T, Matityahu Amir, Fowler Justin T, Pierrie Sarah N, Beltran Michael J, Thomson Cameron G, Lin Carol A, Moon Charles N, Scolaro John A, Amirhekmat Arya, Leonard Jordan, Pogorzelski David, Bzovsky Sofia, Heels-Ansdell Diane, Szasz Olivia P, Gallant Jodi L, Della Rocca Gregory J, Zura Robert D, Hebden Joan N, Patterson Joseph T, Lee Christopher, O'Hara Lyndsay M, Marvel Debra, Palmer Jana E, Friedrich Jeff, D'Alleyrand Jean-Claude G, Rivera Jessica C, Mossuto Franca, Schrank Gregory M, Guyatt Gordon, Devereaux P J, Bhandari Mohit, The PREP-IT Investigators
Аннотация
METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.
RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd 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 were similar in the two groups.
CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).