Recruiting
Phase 1
Phase 2

Negative Pressure Wound Therapy

Sponsor:

Western University, Canada

Code:

NCT02084017

Conditions

Surgical Wound Infection

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prevena (Negative Pressure Wound Therapy Device)

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

Study Details

Brief summary:

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.

Conditions

Surgical Wound Infection

Peripheral Vascular Diseases

Study ID

NCT02084017

Start date

Jul, 2014

Status verified date

Jul, 2015

Completion date

Apr, 2016

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Prevena (Negative Pressure Wound Therapy Device)

No other details required.

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

Primary outcome measure

  • Surgical Site Infection [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Adam Power, MD

519-667-6775Adam.Power@lhsc.on.ca

Locations

Victoria Hospital

Recruiting

London, Ontario, Canada, N6C 2R6

Contacts

Adam Power, MD

519-667-6775Adam.Power@lhsc.on.ca

Principal Investigator:

Adam Power, MD

More Information

Sponsor

Western University, Canada

Last update posted

Jul 31, 2015

Last verified

Jul, 2015

Keywords

  • Surgical Site Infection
  • Vascular Surgery
  • Negative Pressure Wound Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2015-07-31.