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