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

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…

ClinicalTrials.gov IDNCT07365267

PhaseNA

Enrollment25

SponsorXijing Hospital

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Procedure: Implantation 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.

Primary outcomes

postoperative cosmetic results and safety (At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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.

Study locations

the First Affiliated Hospital of the Air Force Medical University, Xi'an, Shaanxi 710032 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.