No phaseRecruiting
Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
Minimally Invasive Post-Traumatic Craniofacial Soft Tissue Regeneration: Validation of Safety and Efficacy of Staged Approach Using Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
- Sponsor
- University of Pittsburgh (Academic or other)
- Enrolment
- 22 planned
- Conditions
- Facial Defect
- Interventions
- Serial Fat Grafting Fresh followed by Cryopreserved Fat
- Ages
- adults, older adults
- Registry
- NCT06747715
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to validate the safety and effectiveness of a two-stage approach for minimally invasive craniofacial soft tissue reconstruction using autologous fat grafting in wounded service members and veterans. The main questions it aims to answer are: 1. Will treating subjects with post-traumatic craniofacial deformities using fresh fat grafts, followed by a second treatment 3 months later with cryopreserved fat stored at -80°C, improve facial tissue regeneration and appearance? 2. How do volume retention and tissue health change between fresh and cryopreserved grafts in humans? 3. How do factors such as cellular composition of the graft, patient demographics, and medical conditions (including diabetes, tobacco use, medications, age, and BMI) affect fat graft volume retention and overall outcomes? Researchers will compare results from the second-stage cryopreserved fat grafting to fresh fat grafting to assess outcomes like volume retention, patient recovery, and cost reduction. Participants will: Undergo an initial fat grafting procedure. Have additional…
Primary outcomes
- Facial volume and appearance scale
History
Primary completion expected
Last registry update
Started
Registered