Evaluation of Autologous Fat Transfer Breast Reconstruction Using the EVEBRA Device Compared to Standard Fat Transfer in Women After Mastectomy

What this Trial Is About

This trial focuses on female breast cancer patients who are scheduled for or have already undergone mastectomy. The study evaluates a new breast reconstruction method called autologous fat transfer AFT using the EVEBRA external vacuum expansion device compared to the standard AFT approach without the device. The goal is to assess differences in breast volume, quality of life, aesthetic outcomes, complications, and oncological safety. Participants are randomized into two groups one group receives AFT combined with the EVEBRA device, which requires wearing the device for 200 hours before surgery over two weeks and then 10 hours daily for two weeks after surgery. After this, they wear a PexyBra over the reconstructed breast. The other group receives AFT without using the EVEBRA device. Reconstruction is performed with three fat grafting sessions. During the study, participants undergo MRI to measure breast volume and tissue quality, complete the Breast-Q questionnaire to assess satisfaction, have breast sensation tested with monofilaments, and have photographic evaluations at 12 months. Researchers will also measure chest circumference and bra cup size changes. The total study period includes follow-up at one year to monitor outcomes, safety, and patient experiences with the reconstruction methods.

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery