Negative Pressure Dressing After Saphenous Vein Harvest

University of Calgary64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Coronary Artery Disease Complication of Coronary Artery Bypass Graft Wound Complication

Interventions

Prevena device (Group A)DEVICE

This portable device is applied to initiate negative pressure therapy to a wound site.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Libin Cardiovascular Institute, Foothills Medical Centre

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 6 weeks

Secondary Outcomes

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.

Time frame: Baseline and 6 weeks

Data from ClinicalTrials.gov

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