Minimally Invasive Two-Stage Craniofacial Reconstruction Using Fresh and Cryopreserved Autologous Fat Grafting for Post-Traumatic Facial Defects

What this Trial Is About

Researchers are evaluating a two-stage minimally invasive method for reconstructing soft tissue in the face using a patients own fat, focusing on wounded service members and veterans with post-traumatic craniofacial deformities. The study aims to compare fresh fat grafts with cryopreserved fat grafts stored at -80C, assessing improvements in facial tissue regeneration, volume retention, and appearance. It also investigates how factors like cellular makeup of the graft, patient demographics, and medical conditions affect outcomes. The treatment involves an initial fat grafting procedure using freshly harvested fat to correct the facial deformity. Extra fat is collected and cryopreserved for a second procedure performed three months later, avoiding the need for another fat harvest. Small test injections are given behind each ear for research analysis. This approach is designed to improve tissue regeneration while reducing patient discomfort and costs associated with multiple fat harvests. Participants will undergo follow-up examinations over approximately six months, including CT scans and facial volume and appearance assessments at three months after each procedure. Researchers will track safety by monitoring treatment-related adverse events and study facial volume changes using high-resolution imaging. The study also collects patient data on demographics and medical history to correlate with treatment outcomes, with all procedures conducted under medical supervision.

Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting