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

NCT07487220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Ischemia-Reperfusion Injury
  • Free Flap
  • Conditioning Therapy

Interventions

DEVICE

Remote ischemic preconditiong

The intervention consists of three cycles of ischemia and reperfusion applied to the upper arm using a pneumatic tourniquet. Each cycle includes 10 minutes of ischemia (inflation to approximately 250 mmHg) followed by 10 minutes of reperfusion (deflation). The total duration of the conditioning procedure is 60 minutes. Participants subsequently undergo free flap reconstruction according to standard institutional protocols.

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07487220 on ClinicalTrials.gov