Skin Antisepsis before Surgical Fixation of Extremity Fractures.

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

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

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.)

Original languageEnglish
Pages (from-to)409-420
Number of pages12
JournalNew England Journal of Medicine
Volume390
Issue number5
DOIs
StatePublished - 1 Feb 2024
Externally publishedYes

Keywords

  • Bacterial Infections
  • Infectious Disease
  • Infectious Disease General
  • Orthopedics
  • Orthopedics General
  • Surgery
  • Surgery General

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