Closed incisional negative-pressure wound therapy vs standard surgical dressing for groin incisions following arterial vascular surgery: A prospective multicenter randomized clinical trial.

Abstract

Groin wound complications-including surgical site infections, hematomas, seroma leakage, necrosis, and wound dehiscence-are frequently reported after arterial vascular surgery and significantly impact patient morbidity and mortality. This multicenter randomized controlled trial evaluated the effectiveness of closed incisional negative-pressure wound therapy (ciNPWT) in reducing these complications. From April 2017 to January 2023, 290 patients with peripheral arterial disease scheduled for arterial vascular surgery requiring a longitudinal groin incision were enrolled in the Netherlands. Patients were randomized to receive either ciNPWT with PREVENA or standard surgical dressing (SSD). Wounds were assessed over a 30-day period at an outpatient wound clinic. The primary outcome was the occurrence of wound complications: infection, seroma, necrosis, and dehiscence, with infections graded according to Centers for Disease Control criteria. A total of 275 patients were analyzed (132 in the ciNPWT group, 143 in the SSD group). Overall, 25.5% of patients experienced wound complications. There was no significant difference in the overall rate of wound complications between the ciNPWT and SSD groups (P = .37). Both groups had a median hospital stay of 4 days, and no significant difference was observed in time to complete wound healing (23.10 ± 20.78 days for ciNPWT vs 22.81 ± 20.73 days for SSD; P = .99). CiNPWT did not reduce the overall rate of wound complications in patients undergoing groin incisions for peripheral arterial surgery. Routine use of ciNPWT in this context is not recommended.