Meta-analysis and trial sequential analysis of prophylactic negative pressure therapy for groin wounds in vascular surgery

Abstract

Background: Negative pressure therapy has been proposed as a prophylactic measure to promote surgical wound healing and reduce surgical site complications.

Methods: We conducted a systematic review of the literature to identify randomized controlled trials (RCTs) comparing prophylactic negative pressure therapy with standard practice in closed groin incisions in vascular surgery. We calculated the pooled odds ratio (OR) or risk difference and 95% confidence interval (CI) with the use of the fixed-effect model. To control the risk of type I error, we adjusted the thresholds for the Z-values with the use of the O'Brien-Fleming α-spending function, and the risk of type II error was controlled with the use of the β-spending function and futility boundaries.

Results: We selected six RCTs reporting on a total of 733 groin wounds. Patients with negative pressure wound therapy had a lower risk of developing surgical site infection (OR, 0.36; 95% CI, 0.24-0.54; P < .001), a lower risk of revision surgery (OR, 0.44; 95% CI, 0.22-0.88; P = .02) and a shorter hospital stay (weighted mean difference, -2.14; 95% CI, -3.78 to 0.49; P = .01). There was no difference in in-hospital mortality (risk difference, 0.01; 95% CI, -0.02 to 0.05; P = .53) or readmission (OR, 0.46; 95% CI, 0.17-1.29; P = .14). The Z-curve for surgical site infection crossed the O'Brien-Fleming significance boundaries for superiority (before the required information size was reached).

Conclusions: Prophylactic negative pressure wound therapy confers improved outcomes in patients undergoing arterial surgery via a groin incision compared with standard surgical wound care.

Keywords: Negative pressure therapy; Surgical site infection; Vacuum-assisted closure.