Faculty Collaboration Database

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial. Trials 2015 Nov 04;16:504

Date

11/06/2015

Pubmed ID

26537879

Pubmed Central ID

PMC4634141

DOI

10.1186/s13063-015-1026-1

Scopus ID

2-s2.0-84946408903 (requires institutional sign-in at Scopus site)   8 Citations

Abstract

BACKGROUND: Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization.

METHODS/DESIGN: In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed.

DISCUSSION: The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs.

TRIAL REGISTRATION: NCT02084017 , March 2014.

Author List

Murphy P, Lee K, Dubois L, DeRose G, Forbes T, Power A

Author

Patrick Murphy MD Assistant Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Clinical Protocols
Cost-Benefit Analysis
Emergency Service, Hospital
Femoral Artery
Health Care Costs
Humans
Length of Stay
Limb Salvage
Lower Extremity
Negative-Pressure Wound Therapy
Ontario
Peripheral Arterial Disease
Prospective Studies
Reoperation
Research Design
Risk Assessment
Risk Factors
Surgical Wound Infection
Time Factors
Treatment Outcome
Vascular Surgical Procedures
Wound Healing