CompletedPhase 1

Negative Pressure Dressing After Saphenous Vein Harvest

Canada64 participantsStarted 2012-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline ASEPSIS score of wound healing at 6 weeks.

Timeframe: Baseline and 6 weeks

Trial details

NCT IDNCT01698372

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Coronary Artery Disease trials