Monitoring blood markers during DIEP flap breast reconstruction
Official title: Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction
Run by Hubei Cancer Hospital · NCT07263347 · Data updated 2026-11-12
We will see if measuring inflammation and oxidative stress markers in blood before and during the first 72 hours after DIEP flap reconstruction helps map recovery patterns for women having immediate breast reconstruction after mastectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | December 20, 2025 |
| Main results expected | September 2026 |
| Study ends | October 2026 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07263347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–70 with breast cancer who are scheduled for immediate DIEP free-flap reconstruction after mastectomy and who can give informed consent are the intended participants.
✕Probably not a fit
Patients with severe cardiac, liver, or kidney dysfunction, active infection, long-term immunosuppression, pregnancy or breastfeeding, prior ipsilateral surgery or radiotherapy, or those not receiving DIEP reconstruction are unlikely to benefit from this observational biomarker mapping.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows women undergoing immediate DIEP free-flap breast reconstruction to track perioperative inflammation and oxidative stress markers in blood, such as interleukin-6, from before surgery through 72 hours after surgery. Serial blood sampling will be used to characterize typical and atypical biomarker patterns associated with ischemia-reperfusion events, fat necrosis, or partial flap loss. No experimental drugs or devices are given to participants, although related animal work on near-infrared imaging and antioxidant nanomaterials is ongoing separately. The results aim to inform future monitoring strategies and protective approaches for flap tissue and will be collected at a single surgical center in Wuhan.
Why it matters
Potential benefit: If successful, the project could help identify early biomarker patterns linked to flap problems so clinicians can monitor patients more closely and intervene sooner to reduce complications.
How similar studies have gone: Prior clinical studies have measured inflammatory and oxidative markers in free-flap and reconstructive surgery and found associations with complications, but therapeutic strategies to prevent ischemia-reperfusion injury remain largely experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Hubei Cancer Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Xinhong Wu Principal Investigator
- Email: wuxinhong_9@sina.com
- Phone: 18602726300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.