Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Calgary
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change from baseline ASEPSIS score of wound healing at 6 weeks.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Prevena device (Group A) (Device)
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.
Outcomes
Primary Outcomes
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 Outcomes
- Total score of pain level.(Baseline and 6 weeks)
Investigators
Dr. Paul Fedak
Associate Professor
University of Calgary