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

NCT07365267 | Recruiting DMC

• 1 other identifier: KY20252568-F-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

3D-Printed Biodegradable Biological Mesh; breast reconstruction

Outcome Measures

Primary Outcomes (1)

• postoperative cosmetic results and safety

  Postoperative Cosmetic Outcome and Safety: Patient satisfaction will be scored using the reconstruction module of the Breast-Q questionnaire, which includes satisfaction with breasts, satisfaction with surgical outcome, and satisfaction with treatment. Satisfaction with breasts will be the primary endpoint of this study. After the BREAST-Q questionnaire is completed, its score, known as the Q-SCORE, will be calculated. The specific evaluation requires the use of Q-SCORE scoring software. The Breast-Q scale also includes scores for satisfaction with surgery, satisfaction with treatment, and health-related quality of life (QOL), covering physical, psychosocial, and sexual well-being. For all dimensions, a higher patient-reported score indicates higher satisfaction and better quality of life.In outcome of BREAST-Q questionnaire, BREAST-Q scales (domains) are scored on a 0-100 range, with higher scores indicating greater satisfaction or better health-related quality of life.

  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.

Secondary Outcomes (4)

• Recurrence-Free Survival (RFS)

  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.

• Disease-Free Survival (DFS)

  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.

• Overall Survival (OS)

  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.

• Surgical Technical Safety (Complication Rate)

  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.

Study Arms (1)

3D printing patient

EXPERIMENTAL

immediate breast reconstruction using 3D-Printed Biodegradable Biological Mesh combined with a silicone breast prosthesis

Procedure: Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh

Interventions

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

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.

3D printing patient

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

the First Affiliated Hospital of the Air Force Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ju Liang Zhang, Prof.

CONTACT

029-84775271; vascularzhang@163.com

Mei Ling Huang, MD

CONTACT

029-84775271; huangmeiling@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 26, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-12

Locations

CN (1)