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DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes

Recruitingn/aAges 18 Years - 70 YearsFemaleHubei Cancer Hospital
NCT07263347 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I/R) injury. I/R injury can happen when a flap has a period without blood flow (ischemia) and then blood flow returns (reperfusion). This process may trigger inflammation and oxidative stress and is associated with fat necrosis or partial flap loss. 1\. What is being studied 1. The investigators will measure inflammation and oxidative stress markers in blood (for example, interleukin-6 \[IL-6\]) from before surgery through the first 72 hours after surgery. 2. These data will help map the normal and abnormal patterns of recovery after surgery and may inform future approaches to monitoring and protecting flap tissue. 3. No experimental drug or device is given to participants in this study. Separate animal stu

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Female, 18-70 years old. 2. Clinically diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy. 3. Conscious and able to understand and voluntarily sign written informed consent. Exclusion Criteria: 1. Severe cardiac, hepatic, or renal dysfunction or severe coagulopathy (e.g., NYHA class III-IV, Child-Pugh class C, eGFR \<30 mL/min/1.73 m²). 2. Preoperative active infection, autoimmune disease, or long-term use of immunosuppressants/anti-inflammatory drugs (e.g., corticosteroids). 3. Pregnant or breastfeeding. 4. Prior ipsilateral breast surgery or radiotherapy that may affect local blood circulation assessment. 5. Any condition deemed unsuitable by the investigator (e.g., poor compliance).
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What it tests

  • Not listed
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Where

1 site
Hubei Cancer Hospital
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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