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Negative Pressure Dressing After Saphenous Vein Harvest

This study is not yet open for participant recruitment.
Verified September 2012 by University of Calgary
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Dr. Paul Fedak, University of Calgary
ClinicalTrials.gov Identifier:
NCT01698372
First received: September 18, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Complication of Coronary Artery Bypass Graft
Wound Complication
 Device: Prevena device (Group A)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change from baseline ASEPSIS score of wound healing at 6 weeks. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Total score of pain level. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.


Estimated Enrollment: 56
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698372

Contacts
Contact: Paul Fedak, MD, PhD 403-944-5931 paul.fedak@albertahealthservices.ca
Contact: Linda B Andersen, PhD 403-944-8076 lbanders@ucalgary.ca

Locations
Canada, Alberta
Libin Cardiovascular Institute, Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Paul Fedak, MD, PhD     403-944-5931     paul.fedak@albertahealthservices.ca    
Contact: Linda B Andersen, PhD     403-944-8076     lbanders@ucalgary.ca    
Principal Investigator: Paul Fedak, MD, PhD            
Sponsors and Collaborators
University of Calgary
KCI USA, Inc.
Investigators
Principal Investigator: Paul Fedak, MD, PhD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Paul Fedak, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01698372     History of Changes
Other Study ID Numbers: KCI VAC Study
Study First Received: September 18, 2012
Last Updated: September 28, 2012
Health Authority: Canada: Health Canada

Keywords provided by 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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013