CompletedNot Applicable

Prevena Incision Management

United Kingdom80 participantsStarted 2016-09-13

Plain-language summary

The question this research project wants to explore is whether using the Prevena Incision Management System (Prevena) will improve sternal wound edge oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts.

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: * Eligible patients are those who require isolated coronary artery bypass surgery, who need at least 2 bypass grafts, and who are deemed suitable by the operating surgeon to have both right and left internal mammary arteries harvested as conduits Exclusion Criteria: * Require additional procedures in addition to the coronary bypass or need for internal mammary artery harvest for feasibility study * Who are deemed by the operating surgeon as unsuitable for bilateral internal mammary artery harvest because of * Age (75 or older where prognostic benefit of using both internal mammary arteries has been questioned), * Obesity with a BMI which is higher than 35 (increased risks of wound infection) * Diabetes (of any type) (increased risks of infection.)

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

NIRS measurement of the inferior third of the parasternal region and left forearm assessment

Timeframe: Measurements taken up to 6 weeks post sternotomy wound dressing

Trial details

NCT IDNCT02814084

SponsorSheffield Teaching Hospitals NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-09

View on ClinicalTrials.gov More Cardiac Event trials

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.