Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization

Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection

The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s).

Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector.

The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.

Study Overview

• Status: Unknown
• Conditions: Peripheral Vascular Diseases; Surgical Wound Infection
• Intervention / Treatment: Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing; Device: Prevena (Negative Pressure Wound Therapy Device)

Detailed Description

The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI > 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device.

Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two.

The data will be analyzed with an intention to treat analysis.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 2R6
      • Recruiting
      • Victoria Hospital
      • Principal Investigator: Adam Power, MD
      • Contact: Adam Power, MD; Phone Number: 519-667-6775; Email: Adam.Power@lhsc.on.ca
      • Sub-Investigator: Guy DeRose, MD
      • Sub-Investigator: Luc Dubois, MD
      • Sub-Investigator: Thomas Forbes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI > 35
• Previous femoral exposure
• Undergoing lower-limb revascularization

Exclusion Criteria:

• Cannot obtain seal
• Non-primary wound closure
• Pre-existing infection
• Endovascular repair

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Current Standard; Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing applied under sterile conditions in the operating room following skin closure. Dressing changed post-operative day two and daily thereafter with daily inspection for infection by a physician.	Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
Experimental: Negative Pressure Wound Therapy; A negative pressure therapy (Kinetic Concepts, Inc, San Antionio, Tex) device will be applied under sterile conditions post-operatively and placed on suction (125-150 cm H2O). The device will be removed on post-operative day 4-7 depending on day of discharge.	Device: Prevena (Negative Pressure Wound Therapy Device); No other details required.; Other Names: Prevena; Prevena Incision Management System; Negative Pressure Wound Therapy Device; Vacuum Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection	Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		30 days
Length of stay	Duration (in days) the patient stays in hospital post-operatively	Date of discharge
Emergency room visits	Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment	30 days
Re-operation rate	Need for re-operation following graft failure secondary to infection	30 days
Amputation	Need for amputation post-operatively secondary to infection	30 days

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: Adam Power, MD, London Health Sciences Center

Publications and helpful links

General Publications

• Lee K, Murphy PB, Ingves MV, Duncan A, DeRose G, Dubois L, Forbes TL, Power A. Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization. J Vasc Surg. 2017 Dec;66(6):1814-1819. doi: 10.1016/j.jvs.2017.06.084. Epub 2017 Aug 31.
• Murphy P, Lee K, Dubois L, DeRose G, Forbes T, Power A. Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial. Trials. 2015 Nov 4;16:504. doi: 10.1186/s13063-015-1026-1.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Vascular Surgery; Negative Pressure Wound Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Postoperative Complications; Disease Attributes; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: RRG-104871