Negative Pressure Dressing After Saphenous Vein Harvest

University of Calgary

Status and phase: Completed; Phase 1

Conditions: Coronary Artery Disease; Complication of Coronary Artery Bypass Graft; Wound Complication

Treatments: Device: Prevena device (Group A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01698372

KCI VAC Study

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Prevena device (Group A)

Experimental group

Description:

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.

Treatment:

Device: Prevena device (Group A)

Conventional dressing (Group B)

No Intervention group

Description:

Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.