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

Breast Cancer Breast Reconstruction After Mastectomy 3D-Printed Biodegradable Biological Mesh

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

Inclusion Criteria5

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.

Exclusion Criteria8

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.

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.