Daniel Charles1, Clare F Heal2, Meth Delpachitra1, Michael Wohlfahrt1, Debbie Kimber1, Julie Sullivan1, Sheldon Browning1, Sabine Saednia1, Alexandra Hardy1, Jennifer Banks1, Petra Buttner1. 1. Discipline of General Practice and Rural Medicine (Charles, Heal, Delpachitra, Wohlfahrt, Hardy, Banks), Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Mackay; Anton Breinl Research Centre for Health Systems Strengthening (Heal), Australian Institute of Tropical Health and Medicine, James Cook University, Townsville; Mackay Institute of Research and Innovation (Heal), Townsville; Paul Hopkins Medical Centre (Kimber, Sullivan), Mackay; Smart Scan Mackay (Browning), Mackay; Mareeba Medical Centre (Saednia), Mareeba; Tropical Health Solutions (Buttner), Townsville; Centre for Chronic Disease Prevention (Buttner), James Cook University, Cairns, Australia. 2. Discipline of General Practice and Rural Medicine (Charles, Heal, Delpachitra, Wohlfahrt, Hardy, Banks), Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Mackay; Anton Breinl Research Centre for Health Systems Strengthening (Heal), Australian Institute of Tropical Health and Medicine, James Cook University, Townsville; Mackay Institute of Research and Innovation (Heal), Townsville; Paul Hopkins Medical Centre (Kimber, Sullivan), Mackay; Smart Scan Mackay (Browning), Mackay; Mareeba Medical Centre (Saednia), Mareeba; Tropical Health Solutions (Buttner), Townsville; Centre for Chronic Disease Prevention (Buttner), James Cook University, Cairns, Australia Clare.heal@jcu.edu.au.
Abstract
BACKGROUND: Preoperative skin antisepsis is routine practice. We compared alcoholic chlorhexidine with aqueous chlorhexidine for skin antisepsis to prevent surgical site infection after minor skin excisions in general practice. METHODS: We conducted this prospective, multicentre, randomized controlled trial in 4 private general practices in North Queensland, Australia, from October 2015 to August 2016. Consecutive adult patients presenting for minor skin excisions were randomly assigned to undergo preoperative skin antisepsis with 0.5% chlorhexidine in 70% ethanol (intervention) or 0.5% chlorhexidine aqueous solution (control). Our primary outcome was surgical site infection within 30 days of excision. We also measured the incidence of adverse reactions. RESULTS:A total of 916 patients were included in the study: 454 underwent antisepsis withalcoholic chlorhexidine and 462 with aqueous chlorhexidine. Of these, 909 completed follow-up. In the intention-to-treat analysis of cases available at follow-up, there was no significant difference in the incidence of surgical site infection between the alcoholic chlorhexidine arm (5.8%, 95% confidence interval [CI] 3.6% to 7.9%) and the aqueous chlorhexidine arm (6.8%, 95% CI 4.5% to 9.1%). The attributable risk reduction was 0.010 (95% CI -0.021 to 0.042), the relative risk was 0.85 (95% CI 0.51 to 1.41), and the number needed to treat to benefit was 100. Per protocol and sensitivity analyses produced similar results. The incidence of adverse reactions was low, with no difference between groups (p = 0.6). INTERPRETATION: There was no significant difference in efficacy between alcoholic and aqueous chlorhexidine for the prevention of surgical site infection after minor skin excisions in general practice. Trial registration: https://www.anzctr.org.au, no. ACTRN12615001045505.
RCT Entities:
BACKGROUND: Preoperative skin antisepsis is routine practice. We compared alcoholic chlorhexidine with aqueous chlorhexidine for skin antisepsis to prevent surgical site infection after minor skin excisions in general practice. METHODS: We conducted this prospective, multicentre, randomized controlled trial in 4 private general practices in North Queensland, Australia, from October 2015 to August 2016. Consecutive adult patients presenting for minor skin excisions were randomly assigned to undergo preoperative skin antisepsis with 0.5% chlorhexidine in 70% ethanol (intervention) or 0.5% chlorhexidine aqueous solution (control). Our primary outcome was surgical site infection within 30 days of excision. We also measured the incidence of adverse reactions. RESULTS: A total of 916 patients were included in the study: 454 underwent antisepsis with alcoholic chlorhexidine and 462 with aqueous chlorhexidine. Of these, 909 completed follow-up. In the intention-to-treat analysis of cases available at follow-up, there was no significant difference in the incidence of surgical site infection between the alcoholic chlorhexidine arm (5.8%, 95% confidence interval [CI] 3.6% to 7.9%) and the aqueous chlorhexidine arm (6.8%, 95% CI 4.5% to 9.1%). The attributable risk reduction was 0.010 (95% CI -0.021 to 0.042), the relative risk was 0.85 (95% CI 0.51 to 1.41), and the number needed to treat to benefit was 100. Per protocol and sensitivity analyses produced similar results. The incidence of adverse reactions was low, with no difference between groups (p = 0.6). INTERPRETATION: There was no significant difference in efficacy between alcoholic and aqueous chlorhexidine for the prevention of surgical site infection after minor skin excisions in general practice. Trial registration: https://www.anzctr.org.au, no. ACTRN12615001045505.
Authors: Clare F Heal; Petra G Buettner; Robert Cruickshank; David Graham; Sheldon Browning; Jayne Pendergast; Herwig Drobetz; Robert Gluer; Carl Lisec Journal: BMJ Date: 2009-01-15