Comparing non - sterile with sterile gloves for minor surgery : a prospective randomised controlled

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 nonsterile gloves group (8.7%; 95% CI, 4.9%–12.6%) was significantly noninferior 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.