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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

RecruitingNAAges 18 Years - 70 YearsFemaleXijing Hospital
NCT07365267 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
the First Affiliated Hospital of the Air Force Medical University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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