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

Arms (1)

1. type

   EXPERIMENTAL

   label

   3D printing patient

   description

   immediate breast reconstruction using 3D-Printed Biodegradable Biological Mesh combined with a silicone breast prosthesis

   interventionNames

   1. Procedure: Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh

Primary outcomes (1)

1. measure

   postoperative cosmetic results and safety

   timeFrame

   At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.

   description

   Postoperative Cosmetic Outcome and Safety: Patient satisfaction will be scored using the reconstruction module of the Breast-Q questionnaire, which includes satisfaction with breasts, satisfaction with surgical outcome, and satisfaction with treatment. Satisfaction with breasts will be the primary endpoint of this study. After the BREAST-Q questionnaire is completed, its score, known as the Q-SCORE, will be calculated. The specific evaluation requires the use of Q-SCORE scoring software. The Breast-Q scale also includes scores for satisfaction with surgery, satisfaction with treatment, and health-related quality of life (QOL), covering physical, psychosocial, and sexual well-being. For all dimensions, a higher patient-reported score indicates higher satisfaction and better quality of life.In outcome of BREAST-Q questionnaire, BREAST-Q scales (domains) are scored on a 0-100 range, with higher scores indicating greater satisfaction or better health-related quality of life.