Monitoring blood markers during DIEP flap breast reconstruction
Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07263347 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xinhong Wu Principal Investigator
- Email: wuxinhong_9@sina.com
- Phone: 18602726300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.