Randomized Controlled Trial of Negative Pressure Wound Therapy for High-Risk Groin Wounds in Lower Extremity Revascularization

Abstract

Revascularization of the lower extremity requiring groin incision is associated with a high rate of surgical site infection (SSI). The objective of this study was to assess the effect of negative pressure wound therapy (NPWT) on rates of infection following primary closure of high-risk groin wounds in vascular surgery patients undergoing lower limb revascularization. We performed a randomized controlled trial at an academic tertiary medical center. High-risk groin wounds were defined as having previous femoral artery cutdown, body mass index >30 kg/m2, or major or minor ischemic tissue loss. We randomized patients to NPWT or standard group once the surgical incision was primarily closed. The primary outcome of the study was overall 30-day groin SSI. Our secondary outcomes were length of stay, readmissions, reoperations, amputations, and mortality. A total of 101 patients were randomized during 13 months. Criteria for inclusion were previous femoral artery cutdown in 24%, >30 kg/m2 body mass index in 36%, and ischemic tissue loss in 40%. The most common revascularization procedure performed was femoral to distal bypass (51%), followed by femoral to femoral artery bypass (20%) and other (29%). Primary outcome of 30-day SSI showed a lower trend but was nonsignificant in the NPWT group (11%) compared with the standard dressing group (19%; P = .24). There was one in-hospital SSI in both groups (P = .96). Length of hospital stay was significantly shorter for the NPWT group compared with the standard group (6.4 days vs 8.9 days; P = .01). We found a trend toward lower groin SSI in high-risk vascular surgery patients treated with NPWT compared with standard dressing. The NPWT group had significantly shorter length of hospital stay than the standard group. Our study was underpowered because of lower than expected infection rates.