CONTEXT: Surgical site infections prolong hospital stays, are among the leading nosocomial causes of morbidity, and a source of excess medical costs. Clinical studies comparing the risk of nosocomial infection after different hand antisepsis protocols are scarce. OBJECTIVE: To compare the effectiveness of hand-cleansing protocols in preventing surgical site infections during routine surgical practice. DESIGN: Randomized equivalence trial. SETTING:Six surgical services from teaching and nonteaching hospitals in France. PATIENTS: A total of 4387 consecutive patients who underwent clean and clean-contaminated surgery between January 1, 2000, and May 1, 2001. INTERVENTIONS:Surgical services used 2 hand-cleansing methods alternately every other month: a hand-rubbing protocol with 75% aqueous alcoholic solution containing propanol-1, propanol-2, and mecetronium etilsulfate; and a hand-scrubbing protocol with antiseptic preparation containing 4% povidone iodine or 4% chlorhexidine gluconate. MAIN OUTCOME MEASURES: Thirty-day surgical site infection rates were the primary end point; operating department teams' tolerance of and compliance with hand antisepsis were secondary end points. RESULTS: The 2 protocols were comparable in regard to surgical site infection risk factors. Surgical site infection rates were 55 of 2252 (2.44%) in the hand-rubbing protocol and 53 of 2135 (2.48%) in the hand-scrubbing protocol, for a difference of 0.04% (95% confidence interval, -0.88% to 0.96%). Based on subsets of personnel, compliance with the recommended duration of hand antisepsis was better in the hand-rubbing protocol of the study compared with the hand-scrubbing protocol (44% vs 28%, respectively; P =.008), as was tolerance, with less skin dryness and less skin irritation after aqueous solution use. CONCLUSIONS: Hand-rubbing with aqueous alcoholic solution, preceded by a 1-minute nonantiseptic hand wash before each surgeon's first procedure of the day and before any other procedure if the hands were soiled, was as effective as traditional hand-scrubbing with antiseptic soap in preventing surgical site infections. The hand-rubbing protocol was better tolerated by the surgical teams and improved compliance with hygiene guidelines. Hand-rubbing with liquid aqueous alcoholic solution can thus be safely used as an alternative to traditional surgical hand-scrubbing.
RCT Entities:
CONTEXT: Surgical site infections prolong hospital stays, are among the leading nosocomial causes of morbidity, and a source of excess medical costs. Clinical studies comparing the risk of nosocomial infection after different hand antisepsis protocols are scarce. OBJECTIVE: To compare the effectiveness of hand-cleansing protocols in preventing surgical site infections during routine surgical practice. DESIGN: Randomized equivalence trial. SETTING: Six surgical services from teaching and nonteaching hospitals in France. PATIENTS: A total of 4387 consecutive patients who underwent clean and clean-contaminated surgery between January 1, 2000, and May 1, 2001. INTERVENTIONS: Surgical services used 2 hand-cleansing methods alternately every other month: a hand-rubbing protocol with 75% aqueous alcoholic solution containing propanol-1, propanol-2, and mecetronium etilsulfate; and a hand-scrubbing protocol with antiseptic preparation containing 4% povidone iodine or 4% chlorhexidine gluconate. MAIN OUTCOME MEASURES: Thirty-day surgical site infection rates were the primary end point; operating department teams' tolerance of and compliance with hand antisepsis were secondary end points. RESULTS: The 2 protocols were comparable in regard to surgical site infection risk factors. Surgical site infection rates were 55 of 2252 (2.44%) in the hand-rubbing protocol and 53 of 2135 (2.48%) in the hand-scrubbing protocol, for a difference of 0.04% (95% confidence interval, -0.88% to 0.96%). Based on subsets of personnel, compliance with the recommended duration of hand antisepsis was better in the hand-rubbing protocol of the study compared with the hand-scrubbing protocol (44% vs 28%, respectively; P =.008), as was tolerance, with less skin dryness and less skin irritation after aqueous solution use. CONCLUSIONS: Hand-rubbing with aqueous alcoholic solution, preceded by a 1-minute nonantiseptic hand wash before each surgeon's first procedure of the day and before any other procedure if the hands were soiled, was as effective as traditional hand-scrubbing with antiseptic soap in preventing surgical site infections. The hand-rubbing protocol was better tolerated by the surgical teams and improved compliance with hygiene guidelines. Hand-rubbing with liquid aqueous alcoholic solution can thus be safely used as an alternative to traditional surgical hand-scrubbing.
Authors: Jan-Peter Braun; Hendrik Mende; Hanswerner Bause; Frank Bloos; Götz Geldner; Marc Kastrup; Ralf Kuhlen; Andreas Markewitz; Jörg Martin; Michael Quintel; Klaus Steinmeier-Bauer; Christian Waydhas; Claudia Spies Journal: Ger Med Sci Date: 2010-09-28