Background: Surgical face masks were originally developed to contain and filter droplets of microorganisms expelled from the mouth and nasopharynx of healthcare workers during surgery, thereby providing protection for the patient. However there are several ways in which surgical face masks could potentially contribute to contamination of the surgical wound.
Objectives: To identify and review all randomised controlled trials evaluating disposable surgical face masks worn by the surgical team during clean surgery to prevent post-operative surgical wound infection.
Search strategy: All relevant publications about disposable surgical face masks were sought through the Specialised Trials Register of the Cochrane Wounds Group (March 2001). Manufacturers and distributors of disposable surgical masks as well as professional organisations including the National Association of Theatre Nurses and the American Operating Room Nurses Association were contacted for details of unpublished and ongoing studies.
Selection criteria: Randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing the use of disposable surgical masks with the use of no mask were included.
Data collection and analysis: Data were extracted independently by AL and PE.
Main results: Two randomised controlled trials were included involving a total of 1453 patients. In a small trial there was a trend towards masks being associated with fewer infections, whereas in a large trial there was no difference in infection rates between the masked and unmasked group. Neither trial accounted for cluster randomisation in the analysis.
Reviewer's conclusions: From the limited results it is unclear whether wearing surgical face masks results in any harm or benefit to the patient undergoing clean surgery.