Article
作者: Della Rocca, Gregory J ; Van Demark, Robert E ; Wood, Amber ; Pierrie, Sarah N ; Chang, Gerard ; Marchand, Lucas S ; Scott, Alesha N ; Heng, Marilyn ; Donegan, Derek J ; Natoli, Roman M ; Apostle, Kelly L ; Domes, Christopher M ; Carroll, Eben A ; Kuhn, Gabrielle R ; Scolaro, John A ; Szatkowski, Jan ; D'Alleyrand, Jean-Claude G ; Gallant, Jodi L ; Shannon, Steven F ; Kempton, Laurence B ; Hymes, Robert A ; Morellato, John ; Rivera, Jessica C ; Karunakar, Madhav ; Patterson, Joseph T ; Bhandari, Mohit ; Gitajn, I Leah ; Potter, G David ; Zura, Robert D ; Thabane, Lehana ; Tanner, Stephanie L ; Wells, Jeffrey L ; Lin, Carol A ; Sprague, Sheila ; Weaver, Michael J ; Demyanovich, Haley K ; von Keudell, Arvind G ; O'Toole, Robert V ; Slobogean, Gerard ; Bergin, Patrick F ; Devereaux, P J ; Romeo, Nicholas M ; Hebden, Joan N ; Pogorzelski, David ; Gaski, Greg E ; Higgins, Thomas F ; Lee, Christopher ; Halvorson, Jason J ; Mossuto, Franca ; Marmor, Meir T ; Gage, Mark J ; Reilly, Rachel M ; Marvel, Debra ; Joshi, Manjari ; Amirhekmat, Arya ; Leonard, Jordan ; McTague, Michael F ; Alnasser, Ahmad ; Guyatt, Gordon ; Viskontas, Darius ; Jaeblon, Todd ; Schrank, Gregory M ; Bzovsky, Sofia ; O'Hara, Lyndsay M ; Al-Asiri, Jamal ; Palmer, Jana E ; Phelps, Kevin D ; Thomson, Cameron G ; O'Hara, Nathan N ; Jeray, Kyle J ; Mullins, C Daniel ; Beltran, Michael J ; Friedrich, Jeff ; Moon, Charles N ; Johal, Herman ; Heels-Ansdell, Diane ; Fowler, Justin T ; Matityahu, Amir ; Szasz, Olivia P ; Babcock, Sharon ; Pilson, Holly T ; Matson, Christopher A ; Harris, Anthony D ; Mehta, Samir
BACKGROUNDStudies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).METHODSIn 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.RESULTSA 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.CONCLUSIONSAmong 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.).