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

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

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.

Conditions4

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