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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

NCT07365267 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2028-06-30
Completion
2028-12-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07365267 on ClinicalTrials.gov