- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01698372
Negative Pressure Dressing After Saphenous Vein Harvest
November 30, 2015 updated by: Dr. Paul Fedak, University of Calgary
Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Libin Cardiovascular Institute, Foothills Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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This portable device is applied to initiate negative pressure therapy to a wound site.
Other Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline ASEPSIS score of wound healing at 6 weeks.
Time Frame: Baseline and 6 weeks
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The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total score of pain level.
Time Frame: Baseline and 6 weeks
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Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.
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Baseline and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Fedak, MD, PhD, University of Calgary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
September 18, 2012
First Submitted That Met QC Criteria
September 28, 2012
First Posted (Estimate)
October 3, 2012
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCI VAC Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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