Clinical Trial

Non-invasive Remote Ischemic PreConditioning (RIPC) in Free Flaps for Breast Reconstruction

Study acronym: RIPC
Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-17.
Trial Details
NCT Number NCT07487220
Lead Sponsor Ruhr University of Bochum
Conditions Ischemia-Reperfusion Injury, Free Flap, Conditioning Therapy
Enrollment 49 participants
Start Date 2021-04-01
Primary Completion 2022-12-31 (estimated)
Study Completion 2023-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-25