Study of Platelet-rich Fibrin-Based Lipobolus for Immediate Breast Reconstruction After Breast-Conserving Surgery in Women with Breast Cancer

What this Trial Is About

Researchers are studying a new approach to repair breast shape defects after breast cancer surgery using a special fat graft called lipobolus, which combines a persons own fat with platelet-rich fibrin PRF, a substance from their blood rich in growth factors. This method aims to improve how well the fat graft survives and integrates after surgery and radiation. The study focuses on women with early-stage, estrogen receptor-positive breast cancer who are undergoing breast-conserving surgery. Participants will have standard breast-conserving surgery to remove their tumor and, during the same operation, will receive liposuction to collect fat from their belly or thighs. This fat is mixed with platelet-rich plasma and calcium chloride to create the lipobolus, which is then placed into the breast defect to restore volume immediately. The procedure is a single surgery combining tumor removal and fat grafting, aiming to reduce the need for multiple fat graft sessions. During the 12-month follow-up, participants will have ultrasound scans, physical exams, and complete questionnaires about their satisfaction and quality of life. Researchers will measure how much of the lipobolus volume remains 3 months after radiotherapy, monitor any complications, and track cancer recurrence. This careful monitoring will help evaluate the safety and effectiveness of the lipobolus graft over time.

Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)