A Multicenter, Prospective Randomized Trial of Negative Pressure Wound Therapy for Infrainguinal Revascularization Groin Incisions

Abby Hart, BS
Department of Surgery
Division of Vascular Surgery
Poster Overview

Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity. The purpose of this study was to assess the impact of negative pressure therapy (PREVENA) on groin wound complications following infrainguinal bypass and femoral endarterectomy.

Patients undergoing infrainguinal bypass or femoral endarterectomy were randomized to PREVENA or standard gauze. The outcome measures were groin wound complications including surgical site infection (SSI), non-infectious wound complications, or graft infection within 30 days of surgery. Adverse events and quality of life (QoL) measures were also included.

There was no difference in the primary outcome at 30-days. SSI, infections, wound complications, adverse event rates, mean length of initial hospitalization were all similar between the PREVENA and control groups. QoL was similar at baseline and at 14 and 30-day postoperatively for the two groups. We found no difference among subgroups: gender, obesity diabetes, smoking, claudication vs. chronic limb threatening ischemia and bypass vs. endarterectomy.

In contrast to other randomized studies, our multicenter trial found no difference in groin wound complications in patients treated with PREVENA and standard gauze. However, the SSI rate was lower in the control group than in other studies, suggesting other practice patterns may have reduced the rate of groin infections.

Scientific Abstract

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

Methods: Patients (n=242) undergoing 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 (PREVENAT, KCI) (n= 118) or standard gauze (n= 124). The primary outcome measure was a composite endpoint of groin wound complications including surgical site infection (SSI), major non-infectious wound complications, or graft infection within 30 days of surgery. Secondary outcome measures included (1) 30-day SSI (2) 30-day non-infectious wound complications, (3) readmission for wound complications, (4) significant adverse events, and (5) health related (HR) quality of life (QoL) by Euro QoL 5D-3L survey.

Results: The ciNPT and control groups had similar demographics (age 67 vs. 67, P= 0.98; male 71% vs. 70%, P= 0.86; Caucasian 93% vs. 93%, P= 0.97), comorbidities (prior or current smoking 93% vs. 94%, P= 0.46; diabetes 41% vs. 48%, P= 0.20; renal insufficiency 4% vs. 7%, P= 0.31) and operative characteristics including procedure type, autogenous conduit and operative time. There was no difference in the primary composite outcome at 30-days: ciNPT vs. control (31% vs. 28%, P= 0.55). SSI at 30 days was similar; ciNPT vs control (11% vs. 12%, P= 0.58). Infectious (13.9% vs. 12.6%, P= 0.77) and non-infectious wound complications (20.9% vs. 17.6%, P= 0.53) at 30-days were similar for ciNPT and control groups respectively. Wound complications requiring readmission were ciNPT vs. control groups (9% vs. 7%, P= 0.54). Significant adverse event rates were not different for ciNPT vs. control groups (13% vs. 16%, P= 0.53). The mean length of initial hospitalization was the same for ciNPT and control (5.2 vs. 5.7 days, P= 0.63). Overall HR QoL was similar at baseline and at 14 and 30-day postoperatively for the two groups. While not powered for stratification, we found no difference among subgroups: gender, obesity diabetes, smoking, claudication vs. chronic limb threatening ischemia and bypass vs. endarterectomy. On multivariable analysis there was no difference in wound complications at 30 days for ciNPT vs gauze (Odds ratio 1.4, 95% CI 0.8-2.6, P= 0.234).

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

Clinical Implications
In contrast to other randomized trials, we found no difference in overall wound complications at 30-days with use of closed incision negative pressure therapy (PREVENA) vs. standard gauze dressing.
Research Areas
Authors
Daniel J. Bertges, MD; Lisa Smith, RN; Rebecca E. Scully, MD MPH; Mark Wyers, MD; Jens Eldrup-Jorgensen, MD; Bjoern Suckow, MD; C. Keith Ozaki, MD; Louis Nguyen, MD
Principal Investigator
Daniel J. Bertges, MD

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