Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Ox… (NCT05750576) | Clinical Trial Compass
CompletedNot Applicable
Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
France270 participantsStarted 2023-06-15
Plain-language summary
The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection
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 with cardiogenic shock or refractory acute respiratory distress syndrome ECMO VA or VV ECMO for less than 24 hours.
* ECMO duration \> 48 hours
* Obtained written informed consent from the trusted person or family member/relative. Depending on the emergency consent, randomization may take place and consent of the trusted person/relative/family will be obtained as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when hid/her condition will allow.
* Affiliation to a social security system (excluding state medical aid)
Exclusion Criteria:
* Age \<18 years
* Initiation of ECMO for more than 24 hours
* Surgical (i.e. non percutaneous) cannulation
* Patient moribund on day of randomization, SAPS II \>90
* Known allergy to chlorhexidine
* Antibiotic prophylaxis at ECMO cannulation
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
1
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
Timeframe: From ECMO initiation date (baseline) and up to day 60