3D-printed Biodegradable Breast Implants for Breast Restoration

Condition(s) studied

Investigational drug(s) / intervention(s)

Breast 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.

Traditional 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.

Traditional 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.

Study 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

Primary outcome measure(s)

• Postoperative cosmetic effects and quality of life — One year after the operation
  Patient satisfaction in the reconstruction module of the BREAST-Q scale is used for scoring, including: satisfaction with the breast, satisfaction with the surgical outcome, and satisfaction with the treatment. Among them, the breast satisfaction score is the main endpoint of this study. After the BREAST-Q questionnaire is completed, its score is calculated and called Q-SCORE. The specific assessment requires the aid of the Q-SCORE scoring software. The surgical satisfaction score, treatment satisfaction score, and health-related quality of life (QOL) score in the Breast-Q scale include: physical, psychosocial, and sexual health. For all dimensions, the higher the score reported by patients, the higher their satisfaction and the better their quality of life.

Trial sites (1)

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