Non-invasive Remote Ischemic PreConditioning (RIPC) in Free Flaps for Breast Reconstruction (NCT07487220) | Clinical Trial Compass
CompletedNot Applicable
Non-invasive Remote Ischemic PreConditioning (RIPC) in Free Flaps for Breast Reconstruction
Germany49 participantsStarted 2021-04-01
Plain-language summary
This prospective randomized clinical study investigates the effects of Remote Ischemic Conditioning (RIC) on tissue perfusion and ischemia-reperfusion injury in patients undergoing free flap reconstruction in reconstructive microsurgery. RIC is a non-invasive conditioning technique using cyclic ischemia and reperfusion applied to an extremity, which may enhance microcirculation and induce tissue protection.
The study aims to evaluate whether preoperative RIC improves postoperative flap perfusion, reduces ischemia-reperfusion- related tissue damage, and enhances clinical outcomes such as flap survival, wound healing, and need for revision surgery. Patients undergoing free flap procedures will be randomized to receive either preoperative RIC (immediate or delayed) or no conditioning.
Additional analyses include continuous postoperative monitoring of microcirculation, histological and molecular assessment of tissue samples, and evaluation of circulating biomarkers associated with tissue protection.
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:
* Age ≥ 18 years
* Patients undergoing free flap reconstruction surgery for reconstruction of body surface defects
* Treatment at the Department of Plastic Surgery, BG Universitätsklinikum Bergmannsheil Bochum
* Ability to understand the study procedures
* Written informed consent to participate in the study
Exclusion Criteria:
* Refusal or inability to provide informed consent
* Contraindications to regional nerve block or perioperative procedures required for the study
* Any condition that prevents participation according to investigator judgment
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
Microcirculatory perfusion of free flap tissue measured by Laser-Doppler flowmetry and tissue spectrometry
Timeframe: From intraoperative revascularization until postoperative day 5