DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes

Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction

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 studies are developing a near-infrared imaging and antioxidant nanomaterial (Mn/QD-SAC); this is not used in participants here.

2. Who can take part

1. Women aged 18-70 scheduled for immediate DIEP flap breast reconstruction after breast cancer surgery.
2. 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.

3. What will happen if you join

1. 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).
2. Blood will be processed and stored under secure conditions and tested for inflammation and oxidative stress markers.
3. 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).
4. Participation does not change the participant's clinical care before, during, or after surgery.

4. Risks and benefits

1. Risks are those of standard blood draws: brief pain, bruising, bleeding, dizziness, and rare infection.
2. There is no direct medical benefit to participants. Results may help improve understanding and future care for patients undergoing flap reconstruction.

5. Privacy and data protection

1. Samples and data will be coded without names. Identifying information is stored separately with restricted access.
2. 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.

6. Time commitment and costs

1. All blood draws occur during the routine hospital stay. There is no additional follow-up required after discharge.
2. There is no cost to participate.

7. Voluntary participation Joining the study is voluntary. Participants may withdraw at any time without affecting their medical care.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Postoperative Complications; Breast Neoplasms; Oxidative Stress; Wound Healing; Ischemia-Reperfusion Injury

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Xinhong Wu Principal Investigator; Phone Number: 18602726300; Email: wuxinhong_9@sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
      • Contact: Xinhong Wu; Email: wuxinhong_9@sina.com
      • Contact: Wu Xinhong; Phone Number: 18602726300; Email: wuxinhong_9@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma tumor necrosis factor alpha (TNF-α) concentration at 24 hours after surgery	EDTA plasma TNF-α (pg/mL) will be quantified using a validated sandwich ELISA. Blood is drawn up to 24 hours prior to surgery (baseline) and at 24 hours after surgery; plasma is processed within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). Samples are run in duplicate. The primary analysis will assess the change in TNF-α from baseline to 24 hours post-surgery as a continuous variable.	Baseline (up to 24 hours before surgery) and 24 hours after surgery.
Plasma interleukin-10 (IL-10) concentration at 24 hours after surgery	EDTA plasma IL-10 (pg/mL) will be quantified using a validated sandwich 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. The analysis will focus on the change in IL-10 concentration from baseline to 24 hours post-surgery as a continuous variable.	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	Plasma malondialdehyde will be measured using a validated thiobarbituric acid reactive substances assay. Blood is collected up to 24 hours prior to surgery (baseline), and at 6 hours and 24 hours after surgery; plasma is processed within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). The area under the concentration-time curve from baseline to 24 hours after surgery will be calculated using the linear trapezoidal method based on the values at the three time points, and analyzed as a continuous variable.	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	Superoxide dismutase activity will be measured using a validated enzymatic activity kit. Blood collection and processing as per Outcome 5. The AUC from baseline to 24 hours will be calculated and analyzed separately as a continuous variable.	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	Glutathione peroxidase activity will be measured using a validated enzymatic activity kit. Blood collection and processing as per Outcome 5. The AUC from baseline to 24 hours will be calculated and analyzed separately as a continuous variable.	Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.
Number of participants with surgical site infection within 30 days	Infection at the flap or donor site meeting CDC criteria (e.g., purulent drainage, positive culture, or surgeon diagnosis requiring treatment). Data will be captured prospectively from medical records and follow-up visits.	From surgery to postoperative day 30

Collaborators and Investigators

• Sponsor: Hubei Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 27, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ischemia-reperfusion injury; Free tissue transfer; Autologous breast reconstruction; Deep inferior epigastric perforator (DIEP) flap
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Inflammation; Postoperative Complications; Reperfusion Injury
• Other Study ID Numbers: LLHBCH2025YN-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to patient privacy and ethical considerations, absence of consent for data sharing, institutional/regulatory restrictions, and limited resources for secure de-identification and data hosting. Aggregate results will be available in publications or upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No