Effectiveness Elusive With Wound-Edge Protection Devices Systematic Review of the Clinical Effectiveness of Wound-Edge Protection Devices in Reducing Surgical Site Infection in Patients Undergoing Open Abdominal Surgery

Background: Wound-edge protection devices (WEPDs) have theoretical advantages as a device that could reduce surgical site infection (SSI). While these devices have been available a long time their use is not routine. Objective: To review current data evaluating WEPDs as a means to reduce SSI rates. Design: Review of existing publications on the effect of WEPDs using Centre for Reviews and Dissemination and Cochrane Handbook protocols. Methods: 12 studies were identified (1993 patients). Inclusion criteria included adults having open abdominal surgery (elective and emergency), prospective data collection, device description, SSI definition, and SSI as the measured outcome. A standard SSI definition was used in only 2 studies: the definition was the Centers for Disease Control (CDC) definition. Primary outcome was rate of SSI. WEPDs were described in 10 studies by manufacturer. A risk of bias assessment was done using Cochrane methods. A random effects and fixed effects model was used. The goal of this investigation was to develop a meta-analysis of data. Heterogeneity was assessed with the I2 statistic. I2 values are from 0% to 100% with higher numbers indicating increasing heterogeneity. Results: 10 studies were randomized clinical trials and 2 were controlled trials. All studies were single institution. Bias within studies was found to be high secondary to patient exclusion and SSI definitions. None of the studies were felt to be adequate for meta-analysis inclusion, but data were used to perform an "exploratory" meta-analysis. Pooling all studies showed a risk ratio of 0.60 for a random effects model and a 0.56 for a fixed effects model. I2 value was 54%. A sub-group analysis showed that the effect of WEPDs on SSI rates was significant for contaminated and dirty wounds but not for clean and clean-contaminated wounds. Conclusions: A beneficial effect of wound protection devices may be present for abdominal surgical case, but data are poor. Reviewer's Comments: SSI has become a focus as a quality indicator for surgery. Surgical Care Improvement Project defines process measures that should improve outcomes although many reports we have reviewed suggest the correlation may not be as great as we thought. Other methods to reduce SSI rates include manipulations of the wound intra or postoperatively. WEPDs are an intraoperative intervention. They attempt to protect the wound from contamination. Their effect would seem obvious for contaminated and dirty wounds. The authors suggest the effect of WEPDs is a 40% SSI rate reduction. However, they add that the quality of data preclude calculation of this odds ratio. This study only serves to reinforce the idea that we need more data to support or refute WEPDs as a strategy to reduce SSIs. (Reviewer-John A. Weigelt, MD, DVM, FACS).