Actively Recruiting
Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction
Led by Hubei Cancer Hospital · Updated on 2026-04-03
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand ischemia-reperfusion (I/R) injury, a common challenge in DIEP flap breast reconstruction surgery for breast cancer patients. I/R injury occurs when blood flow to the flap is temporarily stopped and then restored, potentially causing inflammation, oxidative stress, fat necrosis, or partial flap loss. The study focuses on measuring markers of inflammation and oxidative stress during the surgery and early recovery period to map normal and abnormal healing patterns. Participants are women aged 18 to 70 undergoing immediate DIEP flap breast reconstruction after mastectomy. The study is observational, meaning no experimental drugs or devices are used. Blood samples will be collected before surgery and at 0, 6, 24, and 72 hours after surgery to measure various markers such as interleukin-6 (IL-6) and others related to inflammation and oxidative stress. Researchers will also record clinical data including age, BMI, surgery details, flap outcomes, and any complications. During the hospital stay, participants will have five blood draws totaling about 50 mL. Their clinical information will be collected from medical records without changing their usual care. The primary outcomes include measuring the viable flap area at 7 days after surgery and plasma IL-6 concentration at 24 hours. Secondary outcomes involve other plasma markers and surgical site infections within 30 days. There is no additional follow-up after discharge, and participation involves no extra cost.
CONDITIONS
Brief Title
DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18-70 years old
- Diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy
- Able to understand and voluntarily sign written informed consent
You will not qualify if you...
- Severe cardiac, liver, or kidney dysfunction or severe blood clotting problems
- Active infection, autoimmune disease, or long-term use of immunosuppressants or anti-inflammatory drugs
- Pregnant or breastfeeding
- Prior breast surgery or radiotherapy on the same side affecting blood flow assessment
- Any condition the investigator judges unsuitable, such as poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants undergo immediate autologous breast reconstruction with a DIEP free flap followed by standard peri-operative care. Serial blood samples are collected at baseline (up to 24 hours before surgery) and at 0, 6, 24, and 72 hours after surgery to measure biomarkers related to inflammation and oxidative stress.
1 surgery visit and multiple blood draws during hospital stay
Duration - 30 days
Participants are monitored for surgical site infections and flap viability up to 30 days after surgery.
Follow-up visits as per standard care up to 30 days post-surgery
Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
Research Team
X
Xinhong Wu Principal Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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