Background: Ambiguity remains about the effectiveness of wearing surgical face masks. The purpose of this study was to assess the impact on surgical site infections when non-scrubbed operating room staff did not wear surgical face masks. \ud Design: Randomised controlled trial.\ud Participants: Patients undergoing elective or emergency obstetric, gynecological, general, orthopaedic, breast or urological surgery in an Australian tertiary hospital.\ud Intervention: 827 participants were enrolled and complete follow-up data was available for 811 (98.1%) patients. Operating room lists were randomly allocated to a ‘Mask roup’ (all non-scrubbed staff wore a mask) or ‘No Mask group’ (none of the non-scrubbed staff wore masks). \ud Primary end point: Surgical site infection (identified using in-patient surveillance; post discharge follow-up and chart reviews). The patient was followed for up to six weeks.\ud Results: Overall, 83 (10.2%) surgical site infections were recorded; 46/401 (11.5%) in the Masked group and 37/410 (9.0%) in the No Mask group; odds ratio (OR) 0.77 (95% confidence interval (CI) 0.49 to 1.21), p = 0.151. Independent risk factors for surgical site infection included: any pre-operative stay (adjusted odds ratio [aOR], 0.43 (95% CI, 0.20; 0.95), high BMI aOR, 0.38 (95% CI, 0.17; 0.87), and any previous surgical site infection aOR, 0.40 (95% CI, 0.17; 0.89). \ud Conclusion: Surgical site infection rates did not increase when non-scrubbed operating room personnel did not wear a face mask. \u
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