Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Breast Reconstruction After Mastectomy, 3D-Printed Biodegradable Biological Mesh

In brief

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.

Key facts

Study ID

NCT07365267

Run by

Xijing Hospital

People needed

25

Starts

2026-01-15

Expected to finish

2028-12-01

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female breast cancer patients aged 18 to 70 years.
• Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
• Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
• ECOG performance status of 0-1.
• Voluntary participation in the study and signing of the written informed consent form.

You may not qualify if…

• Age >70 years.
• Metastatic breast cancer (Stage IV) at initial diagnosis.
• Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
• Tumor involvement of the nipple-areolar complex.
• Breast cancer during pregnancy.
• History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer.
• Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery.
• Patients deemed unsuitable for participation by the investigator.

Where it is running

• the First Affiliated Hospital of the Air Force Medical University — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.