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

Western University, Canada

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Peripheral Vascular Diseases; Surgical Wound Infection

Treatments: Device: Prevena (Negative Pressure Wound Therapy Device); Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02084017

RRG-104871

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Current Standard

Active Comparator group

Description:

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.

Treatment:

Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing

Negative Pressure Wound Therapy

Experimental group

Description:

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.

Treatment:

Device: Prevena (Negative Pressure Wound Therapy Device)