Blossom Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction

What this Trial Is About

Researchers are evaluating the Blossom Smart Expander Technology for two-staged tissue expander/implant-based breast reconstruction or augmentation. This study compares the clinical effectiveness of this new device, which aims to reduce the discomfort of frequent saline injections required by standard tissue expanders, by slowly and continuously injecting small amounts of saline based on pressure and volume. The goal is to tailor the expansion process to each patient's physiology. Participants will be randomly assigned to one of two groups: the intervention group will receive the Mentor Spectrum tissue expander combined with the Blossom Syringe Assist device, while the control group will receive the standard tissue expander without this device. Both devices are placed above the pectoralis major muscle during the first stage surgery. Follow-up visits will occur weekly to monitor progress and document clinical data until expansion is complete and surgical scars stabilize, followed by monthly visits as needed until the second stage surgery replaces the expander with a permanent implant. During the study, participants will attend regular postoperative visits starting within one week of surgery. Researchers will assess the time until tissue expansion completion, monitor any complications, and gather patient feedback on satisfaction and pain using surveys at various postoperative time points. The study expects expansion to complete between three and six months after the initial surgery, with complication monitoring continuing until device removal. Overall participation may last up to six months until the second surgery.

Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction