A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision

Abstract

Background: Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy.

Methods: A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey.

Results: The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234).

Conclusions: In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.

Keywords: Groin wound; Infrainguinal revascularization; Negative pressure wound therapy; PREVENA; Surgical site infection.