Negative Pressure Dressing After Saphenous Vein Harvest
|ClinicalTrials.gov Identifier: NCT01698372|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : December 2, 2015
|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|
|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|
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.
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698372
|Libin Cardiovascular Institute, Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Paul Fedak, MD, PhD||University of Calgary|