Negative Pressure Dressing After Saphenous Vein Harvest

Study Overview
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Brief Summary
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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.

Official Title
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Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG

Conditions
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Coronary Artery Disease, Complication of Coronary Artery Bypass Graft, Wound Complication

Intervention / Treatment
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* Device: Prevena device (Group A)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena device (Group A)<br>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)<br>* This portable device is applied to initiate negative pressure therapy to a wound site.<br>* Other names: PRE1001.S Prevena Incision Kit;|
| No Intervention: Conventional dressing (Group B)<br>Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline ASEPSIS score of wound healing at 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. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of pain level. | Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting. | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery., Wound healing., Leg wound infection., Wound care.