Negative Pressure Dressing After Saphenous Vein Harvest
NCT ID: NCT01698372
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2012-09-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Prevena device (Group A)
This portable device is applied to initiate negative pressure therapy to a wound site.
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.
No interventions assigned to this group
Interventions
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Prevena device (Group A)
This portable device is applied to initiate negative pressure therapy to a wound site.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be 18 years or older.
* Must live with one hour driving distance from Calgary.
* Must provide written consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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KCI USA, Inc
INDUSTRY
University of Calgary
OTHER
Responsible Party
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Dr. Paul Fedak
Associate Professor
Principal Investigators
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Paul Fedak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Libin Cardiovascular Institute, Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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References
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Lee AJ, Sheppard CE, Kent WD, Mewhort H, Sikdar KC, Fedak PW. Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):324-328. doi: 10.1093/icvts/ivw400.
Other Identifiers
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KCI VAC Study
Identifier Type: -
Identifier Source: org_study_id