UnknownPhase 4

Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

France478 participantsStarted 2018-12-10

Plain-language summary

The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital. Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.

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: * Subject over 18 years of age, * Subject programmed to benefit from cardiac surgery with sternotomy, * Subject capable and willing to comply with the protocol and willing to give his written consent, * Subject affiliated to a social security system Exclusion Criteria: * Subject with a skin lesion in the sacral area upon admission, * Subject admitted for emergency cardiovascular surgery (unscheduled subject), * Subject admitted for heart transplant surgery, * Subject participating in another clinical study or in a period of exclusion from a study previous, * Subject with a linguistic or psychological disability to sign informed consent, * Subject refusing to give written consent, * Subject deprived of liberty by administrative or judicial decision, under guardianship or curatorship.

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

Pressure ulcer incidence

Timeframe: 0-20 days

Trial details

NCT IDNCT03823963

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-31

Contact for this trial

Lise LACLAUTRE

04 73 75 49 63 drci@chu-clermontferrand.fr

View on ClinicalTrials.gov More Pressure Ulcers trials