Comparing non-sterile to sterile gloves for minor surgery: a prospective randomised controlled non-inferiority trial.

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.