Negative Pressure Dressing After Saphenous Vein Harvest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01698372
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Dr. Paul Fedak, University of Calgary

Brief Summary:
This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Complication of Coronary Artery Bypass Graft Wound Complication Device: Prevena device (Group A) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Study Start Date : September 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prevena device (Group A)
Group A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.
Device: Prevena device (Group A)
This portable device is applied to initiate negative pressure therapy to a wound site.
Other Names:
  • Prevena Incision Management System
  • Prevena 125
  • PRE1001.S Prevena Incision Kit
No Intervention: Conventional dressing (Group B)
Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.

Primary Outcome Measures :
  1. Change from baseline ASEPSIS score of wound healing at 6 weeks. [ Time Frame: Baseline and 6 weeks ]
    The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.

Secondary Outcome Measures :
  1. Total score of pain level. [ Time Frame: Baseline and 6 weeks ]
    Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein.
  • Must be 18 years or older.
  • Must live with one hour driving distance from Calgary.
  • Must provide written consent.

Exclusion Criteria:

  • Previous CABG surgery or previous lower leg surgical intervention.
  • In emergent need for surgery.
  • Have severe peripheral vascular disease.
  • Do not speak and read the English language.
  • Have dialysis-dependent renal failure.
  • Require chronic steroids.
  • Unable to return to clinic for follow-up due to functional or cognitive impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01698372

Canada, Alberta
Libin Cardiovascular Institute, Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Principal Investigator: Paul Fedak, MD, PhD University of Calgary

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Paul Fedak, Associate Professor, University of Calgary Identifier: NCT01698372     History of Changes
Other Study ID Numbers: KCI VAC Study
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Dr. Paul Fedak, University of Calgary:
Cardiac surgery.
Wound healing.
Leg wound infection.
Wound care.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases