Actively Recruiting
Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
Led by Xijing Hospital · Updated on 2026-01-26
25
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
CONDITIONS
Official Title
Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients aged 18 to 70 years
- Histopathologically confirmed invasive breast cancer according to latest ASCO/NCCN guidelines
- Unable or unwilling to have breast-conserving surgery and opting for total mastectomy with immediate implant-based reconstruction
- ECOG performance status between 0 and 1
- Voluntary participation with signed informed consent
You will not qualify if you...
- Age over 70 years
- Metastatic breast cancer (Stage IV) at initial diagnosis
- Multicentric, extensive, diffuse lesions, or inflammatory breast cancer
- Tumor involving the nipple-areolar complex
- Breast cancer diagnosed during pregnancy
- History of other malignancies within the past 5 years, except cured cervical carcinoma in situ or non-melanoma skin cancer
- Abnormal heart, lung, liver, or kidney function or poorly controlled diabetes making surgery unsafe
- Patients considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
J
Ju Liang Zhang, Prof.
CONTACT
M
Mei Ling Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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