DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes

NCT07263347 | Not Yet Recruiting

• 1 other identifier: LLHBCH2025YN-075
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.No experimental drug or device is given to participants in this study. Separate animal studies are developing a near-infrared imaging and antioxidant nanomaterial (Mn/QD-SAC); this is not used in participants here.
4. 4.Women aged 18-70 scheduled for immediate DIEP flap breast reconstruction after breast cancer surgery.
5. 5.Key exclusions include severe heart, liver, or kidney disease; significant clotting problems; active infection or autoimmune disease; long-term use of immunosuppressants/anti-inflammatory drugs; pregnancy or breastfeeding; or other reasons judged by the research team.
6. 6.After providing informed consent, participants will have blood drawn at five time points: pre-operative baseline (within 24 hours before surgery) and at 0, 6, 24, and 72 hours after surgery (about 10 mL each time; total \~50 mL).
7. 7.Blood will be processed and stored under secure conditions and tested for inflammation and oxidative stress markers.
8. 8.The investigators will also record routine clinical information from the medical record (such as age, BMI, surgery duration, ischemia time, and clinical assessments of flap outcomes and complications).
9. 9.Participation does not change the participant's clinical care before, during, or after surgery.
10. 10.Risks are those of standard blood draws: brief pain, bruising, bleeding, dizziness, and rare infection.
11. 11.There is no direct medical benefit to participants. Results may help improve understanding and future care for patients undergoing flap reconstruction.
12. 12.Samples and data will be coded without names. Identifying information is stored separately with restricted access.
13. 13.Research results are not routinely added to the medical record or returned to participants unless a finding has clear, actionable clinical significance and is approved by the ethics committee.
14. 14.All blood draws occur during the routine hospital stay. There is no additional follow-up required after discharge.
15. 15.There is no cost to participate.

Conditions

Breast Neoplasms; Ischemia-Reperfusion Injury; Postoperative Complications; Wound Healing; Oxidative Stress; Inflammation

Keywords

Deep inferior epigastric perforator (DIEP) flap; Autologous breast reconstruction; Free tissue transfer; Ischemia-reperfusion injury

Outcome Measures

Primary Outcomes (2)

• Viable DIEP flap area (%) at postoperative day 7

  Standardized digital photographs will be obtained on POD7 under uniform lighting and distance with a calibration ruler. Viable flap area (%) is calculated as \[viable area/total area\]×100 using blinded planimetry by two independent raters; discrepancies \>5% are adjudicated by a third rater. This endpoint reflects clinical benefit and flap survival. This is a co-primary endpoint with IL-6; the family-wise error rate is controlled at 0.05 using the Bonferroni correction (two-sided α=0.025 per endpoint).

  Postoperative day 7

• Plasma interleukin-6 (IL-6) concentration at 24 hours after surgery

  Plasma IL-6 (pg/mL) will be quantified in EDTA plasma using a validated sandwich enzyme-linked immunosorbent assay (ELISA). Blood is drawn up to 24 hours prior to surgery (baseline) and at 24 hours after surgery; plasma is separated within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). Samples are run in duplicate with a 7-point standard curve and quality control samples. The co-primary analysis will focus on the change in IL-6 from baseline to 24 hours post-surgery, analyzed as a continuous variable with prespecified covariates (age, body mass index, ischemia time, operative duration). This endpoint is co-primary with flap viability; the Bonferroni-adjusted family-wise error rate is 0.05 (two-sided alpha=0.025).

  Baseline (up to 24 hours before surgery) and 24 hours after surgery.

Secondary Outcomes (6)

• Plasma tumor necrosis factor alpha (TNF-α) concentration at 24 hours after surgery

  Baseline (up to 24 hours before surgery) and 24 hours after surgery.

• Plasma interleukin-10 (IL-10) concentration at 24 hours after surgery

  Baseline (up to 24 hours before surgery) and 24 hours after surgery.

• Area under the curve (AUC) for plasma malondialdehyde from baseline to 24 hours after surgery

  Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.

• Area under the curve (AUC) for plasma superoxide dismutase activity from baseline to 24 hours after surgery

  Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.

• Area under the curve (AUC) for plasma glutathione peroxidase activity from baseline to 24 hours after surgery

  Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.

Study Arms (1)

DIEP flap reconstruction patients (longitudinal peripheral blood cohort)

Prospective observational cohort of women (18-70 years) undergoing immediate autologous breast reconstruction with a DIEP free flap. Standard peri-operative care only; no investigational imaging or drug (no Mn/QD-SAC) is administered. Serial peripheral blood is collected at pre-op baseline (≤24 h) and at 0 h, 6 h, 24 h, and 72 h post-op (≈10 mL/timepoint; serum + EDTA plasma). Primary measurement is plasma IL-6; additional analytes include IL-1β, TNF-α, IL-8, IL-10, IL-18, HMGB1, vWF, VEGF, HIF-1α, MDA, 8-iso-PGF2α, SOD, CAT, GSH-Px, lactate, LDH, PT/APTT/fibrinogen, D-dimer, and CBC. Samples are processed within 2 h and stored at -80°C for batch ELISA/biochemical assays. Clinical data (age, BMI, operative/ischemia times, flap perfusion assessments, complications, fat necrosis/partial flap loss) are recorded. Target enrollment \~30 participants.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult women (18-70 years) with breast cancer at Hubei Cancer Hospital undergoing mastectomy with immediate DIEP free-flap breast reconstruction. Approximately 30 consecutive eligible patients able to provide written informed consent will be enrolled. Exclusions include severe cardiac/hepatic/renal dysfunction or severe coagulopathy, preoperative active infection, autoimmune disease or chronic immunosuppressive/anti-inflammatory therapy (e.g., corticosteroids), pregnancy or breastfeeding, and prior ipsilateral breast surgery or radiotherapy. This is an observational perioperative biomarker cohort; no investigational agents or devices are administered.

You may qualify if:

• Female, 18-70 years old.
• Clinically diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy.
• Conscious and able to understand and voluntarily sign written informed consent.

You may not qualify if:

• 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).
• Preoperative active infection, autoimmune disease, or long-term use of immunosuppressants/anti-inflammatory drugs (e.g., corticosteroids).
• Pregnant or breastfeeding.
• Prior ipsilateral breast surgery or radiotherapy that may affect local blood circulation assessment.
• Any condition deemed unsuitable by the investigator (e.g., poor compliance).

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only acellular fractions from DIEP patients' peripheral blood will be retained: serum (clot-activator tube) and EDTA plasma supernatant. Samples will be centrifuged to remove cells and platelets (platelet-poor plasma as needed), aliquoted, and stored at -80°C for inflammation/oxidative-stress protein and metabolite assays (e.g., IL-6, TNF-α, IL-10, MDA, SOD, CAT, VEGF, D-dimer, lactate, LDH). No long-term retention of whole blood, buffy coat/nucleated cells, PBMCs, saliva, urine, tissue, or swabs; any leftover whole blood from clinical labs will be destroyed per policy. All human specimens are de-identified and labeled with study IDs. No DNA/RNA extraction or sequencing will be performed on any retained human specimen.

MeSH Terms

Conditions

Breast Neoplasms; Reperfusion Injury; Postoperative Complications; Inflammation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xinhong Wu Principal Investigator

CONTACT

18602726300; wuxinhong_9@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)