Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR-A Randomized Trial.

ABSTRACT

BACKGROUND: Surgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR). METHODS: A multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other's control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher's method for combining P-values. Study protocol (NCT01913132). RESULTS: The SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined p = 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up. CONCLUSIONS: No evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure. CLINICAL TRIALS NCT01913132.