Clinical Trial

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

Recruiting
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Summary
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.
Trial Details
NCT Number NCT07365267
Lead Sponsor Xijing Hospital
Conditions Breast Cancer, Breast Reconstruction After Mastectomy, 3D-Printed Biodegradable Biological Mesh
Enrollment 25 participants
Start Date 2026-01-15
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-26