Non-invasive Remote Ischemic PreConditioning in Free Flaps for Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Microcirculatory perfusion of free flap tissue measured by Laser-Doppler flowmetry and tissue spectrometry
研究概览
简要总结
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.
详细描述
Background and Rationale
Ischemia, impaired microcirculation, and ischemia-reperfusion (I/R) injury are major causes of complications in free flap surgery, contributing to partial or total flap loss. Despite advances in microsurgical techniques, flap loss rates remain clinically relevant.
Remote Ischemic Conditioning (RIC) is a non-invasive method that induces systemic protective mechanisms through repeated short cycles of ischemia and reperfusion applied to a limb. Experimental and early clinical data suggest that RIC improves tissue perfusion and reduces susceptibility to ischemic injury. However, its clinical efficacy in reconstructive microsurgery has not yet been evaluated in a randomized controlled setting.
Objectives
The primary objective is to assess the effect of preoperative RIC on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Microcirculatory perfusion of free flap tissue measured by Laser-Doppler flowmetry and tissue spectrometry
时间窗: From intraoperative revascularization until postoperative day 5
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.
次要结局
- 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)
研究者
ALEXANDER FIEDLER
Resident Physician, Department of Plastic, Reconstructive and Burn Surgery
Ruhr University of Bochum