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

NCT07487220 | Completed

• 1 other identifier: 19-6752
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ischemia; reperfusion; free flap; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Microcirculatory perfusion of free flap tissue measured by Laser-Doppler flowmetry and tissue spectrometry

  Continuous assessment of microcirculatory perfusion parameters of free flap tissue using combined Laser-Doppler flowmetry and tissue spectrometry (O2C system). Parameters include blood flow (BF), tissue oxygen saturation (StO₂), and relative hemoglobin concentration (rHb) measured in the transplanted tissue to evaluate the effect of remote ischemic conditioning on flap perfusion and ischemia-reperfusion injury.

  From intraoperative revascularization until postoperative day 5

Secondary Outcomes (2)

• Incidence of flap tissue necrosis following free flap reconstruction

  Up to postoperative day 5

• Histological markers of vascularization and ischemia-reperfusion injury in flap tissue

  From intraoperative sampling after revascularization until postoperative day 5-7

Study Arms (3)

No RIPC

NO INTERVENTION

No Remote Ischemic Conditioning (RIC) is administered. Participants receive standard perioperative care and undergo free flap reconstruction according to institutional protocols without any preconditioning intervention.

Early RIPC

EXPERIMENTAL

Remote Ischemic Conditioning (RIC) is performed 12-24 hours prior to surgery. 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.

Device: Remote ischemic preconditiong

Late RIPC

EXPERIMENTAL

Remote Ischemic Conditioning (RIC) is performed one hour prior to surgery. 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.

Device: Remote ischemic preconditiong

Interventions

Remote ischemic preconditiong DEVICE

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.

Early RIPC; Late RIPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

BG University Clinic Bergmannsheil

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Related Publications (2)

• Drysch M, Fiedler A, Schmidt SV, Reinkemeier F, Puscz F, Kurbacher T, Frey UH, Ochsenfarth C, Lehnhardt M, Wallner C, Sogorski A. Systemic downregulation of EV-associated MiRNAs following remote ischemic preconditioning. Sci Rep. 2025 Dec 11;15(1):43657. doi: 10.1038/s41598-025-31356-9.

  PMID: 41381697 RESULT

• Drysch M, Fiedler A, Kurbacher T, Schmidt SV, Reinkemeier F, Puscz F, Becerikli M, Fueth M, Weskamp P, Lehnhardt M, Wallner C, Sogorski A. Ischemia-Reperfusion Injury in Free Flaps: Molecular Mechanisms and Protective Effects of Remote Ischemic Preconditioning. J Cell Mol Med. 2025 Aug;29(15):e70739. doi: 10.1111/jcmm.70739.

  PMID: 40771071 RESULT

MeSH Terms

Conditions

Reperfusion Injury; Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Plastic, Reconstructive and Burn Surgery

Model Details: Participants undergoing free flap reconstruction will be randomly assigned to one of three parallel groups: (1) no remote ischemic conditioning (control), (2) remote ischemic conditioning 12-24 hours prior to surgery, or (3) remote ischemic conditioning immediately prior to surgery. Participants remain in their assigned study arm throughout the study period. In cases of postoperative flap perfusion compromise requiring revision surgery, participants will undergo a secondary randomization to receive either additional remote ischemic conditioning or no conditioning prior to revision.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 25, 2026

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)