Objective: To compare the incidence of infection after minor surgery conducted using non-sterile clean boxed gloves with surgery conducted using sterile gloves.
Design: Prospective randomised controlled single-centre trial testing for non-inferiority in infection rates.
Setting: Primary care regional centre, Queensland, Australia.
Participants: Consecutive patients presenting to participating general practitioners for a minor skin excision, between 30 June 2012 and 28 March 2013, were eligible to participate.
Intervention: The use of non-sterile clean boxed gloves was compared with normal treatment using sterile gloves in the control group.
Main outcome measures: Wound infection, assessed at the time of removal of sutures, and other adverse events.
Results: Four hundred and ninety-three consecutive patients presenting for minor skin excisions were randomly allocated to the two treatment groups: non-sterile clean boxed gloves (n = 250) or sterile gloves (n = 243). Four hundred and seventy-eight patients contributed data for analysis (241 non-sterile, 237 sterile gloves). The incidence of infection in the non-sterile gloves group (8.7%; 95% CI, 4.9%-12.6%) was significantly non-inferior compared with the incidence in the control group (9.3%; 95% CI, 7.4%-11.1%). The two-sided 95% CI for the difference in infection rate (- 0.6%) was - 4.0% to 2.9%, and did not reach the predetermined margin of 7% which had been assumed as the non-inferiority limit. RESULTS of the intention-to-treat analysis were confirmed by per-protocol and sensitivity analyses. There were no important adverse effects.
Conclusion: Our study suggests that in regard to wound infection, non-sterile clean boxed gloves are not inferior to sterile gloves for minor skin excisions in general practice.
Trial registration: ACTRN12612000698875.