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. Surgical face masks have recently been advocated as a protective barrier between the surgical team and the patient, but the role of the surgical face mask as an effective measure in preventing surgical wound infections is questionable. The aim of the systematic review is to identify and review all randomised controlled trials evaluating disposable surgical face masks worn by the surgical team during clean surgery to prevent postoperative surgical wound infection. 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the National Association of Theatre Nurses and the Association of Operating Room Nurses were contacted for details of unpublished and ongoing studies. Randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing the use of disposable surgical masks with the use of no mask were included.
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.
Reviewers' 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.