Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: A Randomized Controlled Trial-INVIPS Trial.

Abstract

A randomized controlled trial (RCT) was undertaken to determine the effect of negative pressure wound therapy (NPWT) on closed incisions after inguinal vascular surgery regarding surgical site infections (SSIs) and other wound complications. SSIs are a major concern in open vascular procedures involving the inguinal region. Prophylactic NPWT on closed incisions has shown promising results, but the quality of evidence can be debated. This study aims to objectively evaluate whether NPWT on sutured inguinal incisions after elective vascular surgery can decrease the incidence of surgical site complications. One hundred thirty-nine patients undergoing elective open vascular surgery with inguinal incisions received either NPWT or a standard dressing. Patients with bilateral incisions randomly received a dressing on one incision and the opposite dressing on the other. The primary endpoints were SSI or other wound complications at 3 months, assessed by wound care experts blinded to the treatment arm and using objective wound assessment criteria (ASEPSIS-score). Statistical analysis was performed on an intention-to-treat basis and obtained P values from analyses in the uni- and bilateral groups were combined to an overall P value using Fisher's method for combining P values. The incidence of SSI was reduced in the NPWT group compared with the control group [11.9% vs 29.5% in the unilateral group (n = 120), 5.3% vs 26.3% in the bilateral group (n = 19), respectively; combined P = 0.02]. No differences regarding other surgical site complications were observed between the groups. NPWT on closed inguinal vascular surgical incisions in elective patients reduces the incidence of SSI.