RecruitingPhase 2NCT06993714

3D-printed Biodegradable Breast Implants for Breast Restoration

A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration

Sponsor

Xijing Hospital

Enrollment

120 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Reconstruction

Summary

The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is: Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction? Participants will: Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
ECOG performance status score: 0-1.
If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.

Exclusion Criteria9

Age \> 70 years.
Newly diagnosed stage IV metastatic breast cancer.
Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
Tumor invasion of the papillary areola complex.
Inability to accept/tolerate radiotherapy.
Breast cancer during pregnancy.
History of other malignant tumors within the past five years (except cured cervical carcinoma in situ and non-melanoma skin cancer).
Abnormal functions of vital organs (heart, lungs, liver, kidneys), poorly controlled diabetes, or other conditions that preclude surgery tolerance.
Patients deemed unsuitable for participation by the researchers.

Interventions

PROCEDUREBreast restoration surgery based on 3D printed degradable biological implants

In the experimental group, the surgeon makes an incision on the skin and creates an electrosurgical free flap with a thickness of approximately 3mm. Based on the tumor size simulated by the computer and combined with real-time exploration during the operation, the tumor is resected. The incision margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the resected specimen. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are excluded from the clinical trial). Corresponding surgical treatment is provided. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The wound is soaked and rinsed, hemostasis is thoroughly achieved, the designed 3D printed filler is implanted, and sutured and fixed. After placing the drainage, the skin is sutured layer by layer. The corresponding operation time is recorde.

PROCEDURETraditional breast-conserving surgery

In the control group undergoing traditional breast - saving surgery, tumor segment resection is performed according to the clinical routine. The resection margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the circumferential specimens after resection. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative resection margin. The volume of the resected part during the intraoperative section is replaced by autologous tissue. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The corresponding operation time is recorded.

PROCEDURETraditional silicone prosthesis breast reconstruction

In the control group of traditional prosthesis reconstruction, subcutaneous gland resection with nipple and areola preservation combined with prosthesis for concurrent breast reconstruction is carried out according to the clinical routine. The incision method is selected by the surgeon. During the operation, the tissue behind the nipple is sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are considered out of the clinical trial and given corresponding surgical treatment), and the surgeon decides whether to use the patch in combination. The corresponding operation time is recorded.