OBJECTIVE:: Assess the existing evidence on the clinical effectiveness of wound-edge protection devices (WEPDs) in reducing the surgical site infection (SSI) rate in patients undergoing open abdominal surgery. BACKGROUND:: Surgical site infections are a common postoperative complication associated with considerable morbidity, extended hospital stay, increased health care costs, and reduced quality of life. Wound-edge protection devices have been used in surgery to reduce SSI rates for more than 40 years; however, they are yet to be cited in major clinical guidelines addressing SSI management. METHODS:: A review protocol was prespecified. A variety of sources were searched in November 2010 for studies containing primary data on the use of WEPDs in reducing SSI compared with standard care in patients undergoing open abdominal surgery. The outcome of interest was a well-specified, clinically based definition of an SSI. No language or time restrictions were applied. The quality assessment of the studies and the quantitative analyses were performed in line with the principles of the Cochrane Collaboration. RESULTS:: Twelve studies reporting primary data from 1933 patients were included in the review. The quality assessment found all of them to be at considerable risk of bias. An exploratory meta-analysis was performed to provide a quantitative indication on the effect of WEPDs. The pooled risk ratio under a random effects model was 0.60 (95% confidence interval, 0.41-0.86), indicating a potentially significant benefit from the use of WEPDs. No indications of significant between-study heterogeneity or publication bias, respectively, were identified. CONCLUSIONS:: Evidence to date suggests that WEPDs may be efficient in reducing SSI rates in patients undergoing open abdominal surgery. However, the poor quality of the existing studies and their small sample sizes raise the need for a large, good quality randomized controlled trial to validate this indication.