Background: Despite substantial prevention efforts, surgical site infections (SSIs) remain the most common health care-associated infection. It is unclear whether the Centers for Disease Control and Prevention recommendation to leave hair intact preoperatively reduces SSIs.
Study design: A single-center, prospective, randomized, clinical trial was conducted from October 2009 to February 2015 in a 325-bed multispecialty, tertiary care teaching hospital to test the noninferiority of clipping hair to no hair removal in the prevention of SSIs. A total of 4,908 adults scheduled for elective general surgical procedures were screened for study participation. Of these, 600 were approached but refused, and 2,630 were excluded. Patients were randomized 1:1 to either the clipped group (n = 834) or the not-clipped group (n = 844). The clipped group had hair at the surgical site removed using disposable electric clippers. Of the randomized patients, 1,543 (768 in the clipped group and 775 in the not-clipped group) completed follow-up. The primary endpoint was the proportion of patients who could be evaluated and who had no SSI, as defined by CDC criteria.
Results: Baseline demographic, clinical, and surgical characteristics were similar between groups. The overall rate of SSI in the per-protocol analysis was 6.12% (47 of 768) in the clipped group and 6.32% (49 of 775) in the not-clipped group (absolute risk difference -0.20%; 95% CI -2.61% to 2.21%), p = 0.037). Because the absolute risk difference confidence interval included the prespecified noninferiority margin of 2%, we were unable to definitively demonstrate noninferiority for clipping hair.
Conclusions: Surgical site infection rates were similar whether hair was clipped or not in patients undergoing general surgical procedures.
Trial registration: ClinicalTrials.gov NCT00975377.
Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.