MedTrace Logo

DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes

NCT07263347 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-04-03

No results posted yet for this study

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. 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.

Conditions

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

Sponsors & Collaborators

  • Hubei Cancer Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263347 on ClinicalTrials.gov