Actively Recruiting
Minimally Invasive Post-Traumatic Craniofacial Soft Tissue Regeneration Using Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
Led by University of Pittsburgh · Updated on 2025-10-22
22
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
A
Armed Forces Institute of Regenerative Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a two-stage minimally invasive method for reconstructing soft tissue in the face using a patient's 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 -80°C, 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.
CONDITIONS
Brief Title
Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and able to provide informed consent
- Have craniofacial volume defects from injury or surgery treatable with 3 to 150 cc of fat graft
- At least 3 months post-injury or surgery with resolved swelling
- Facial defects covered by intact skin, not communicating with oral cavity or sinuses
- Volume defects suitable for fat grafting based on 3D geometry
- Sufficient donor fat tissue for grafting and cryopreservation
- Willing and able to comply with follow-up exams including CT scans
You will not qualify if you...
- Younger than 18 years
- Unable to provide informed consent
- Craniofacial defects with open wounds or communicating with oral cavity or sinuses
- Active infection anywhere in the body
- Medical conditions making fat harvest or anesthesia unsafe
- History of radiation to treatment or harvest areas
- Medications impairing wound healing or posing anesthesia risk
- Active narcotic abuse
- Known bleeding disorders or clotting problems
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the first surgical procedure involving autologous fat grafting using freshly harvested adipose tissue to treat craniofacial volume defects.
1 surgery visit (in-person)
Duration - Up to 1 week after the first surgery
Participants receive immediate post-operative care following the first fat grafting procedure.
Approximately 3 post-operative visits
Duration - 1 day
Participants undergo a second surgical procedure using autologous adipose tissue that was cryopreserved during the first procedure, performed approximately 3 months after the first surgery.
1 surgery visit (in-person)
Duration - Up to 1 week after the second surgery
Participants receive immediate post-operative care following the second fat grafting procedure.
Approximately 3 post-operative visits
Duration - 3 months after second surgery
Participants are monitored for safety, tolerability, and treatment outcomes including facial volume and appearance, with follow-up lasting up to 3 months after the second treatment.
Regular follow-up visits including CT scans to assess facial volume changes
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Actively Recruiting
Research Team
E
Eleanor Shirley, MA, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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