RecruitingNot ApplicableNCT07365267

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

Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study


Sponsor

Xijing Hospital

Enrollment

25 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and cosmetic outcomes of using a 3D-printed biodegradable biological mesh during immediate implant-based breast reconstruction following mastectomy for breast cancer. The mesh is designed to support the implant and break down naturally over time. **You may be eligible if...** - You are a woman aged 18 to 70 with confirmed invasive breast cancer - You are unable to have or are choosing to have a full mastectomy rather than breast-conserving surgery - You want immediate breast reconstruction with an implant at the time of mastectomy - You are in good overall physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your breast cancer has already spread to other parts of the body (Stage IV) - You have inflammatory breast cancer or cancer in multiple areas of the breast - You have had another cancer in the past 5 years - You are pregnant - You have had prior radiation to the chest area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREImplantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh

Nipple-sparing subcutaneous mastectomy combined with an implant for immediate breast reconstruction will be performed according to standard clinical practice. The choice of incision will be at the surgeon's discretion. Intraoperatively, tissue from behind the nipple will be sent for frozen section histopathological examination. If the margin is positive, the nipple-areolar complex will be resected following safety principles. The 3D-printed biodegradable biological mesh will be used to wrap the silicone implant, which is then placed in the subcutaneous tissue. The wound will be soaked and irrigated with sterile distilled water and normal saline. After achieving thorough hemostasis, a drain will be placed, and the skin will be closed in layers.


Locations(1)

the First Affiliated Hospital of the Air Force Medical University

Xi'an, Shaanxi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07365267


Related Trials