Fat Grafting for Facial Defect

Overseen By Eleanor Shirley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Immunosuppressants, Steroids, Chemotherapy, others

Disqualifiers: Active infection, Radiation history, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

22 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that significantly impact wound healing, like immunosuppressive agents, chronic steroids, or chemotherapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment Autologous Cryopreserved Fat Grafting and Autologous Fresh Fat Grafting for facial defects?

Research shows that autologous fat grafting (using a person's own fat) is popular for facial rejuvenation and body contouring, helping to restore volume and improve appearance. It is commonly used alongside facelift surgeries to address age-related volume loss in the face. ^{1 2 3 4 5}

Is fat grafting for facial defects safe?

Fat grafting for facial defects is generally considered safe, but there are risks of serious complications like arterial embolism (blockage of an artery) and fat embolism (fat entering the bloodstream and blocking blood vessels). Proper surgical techniques can help minimize these risks. ^{2 6 7 8 9}

How is the treatment Autologous Fresh Fat Grafting unique for facial defects?

Autologous Fresh Fat Grafting is unique because it uses a person's own fat, harvested through liposuction, to fill in facial defects, offering a natural and biocompatible option. Unlike synthetic fillers, this method can provide longer-lasting results and is less likely to cause allergic reactions. ^{1 3 5 10 11}

What is the purpose of this trial?

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 fat harvested and cryo-stored for use in a second-stage procedure. Receive the cryopreserved fat in a later stage without the need for a second fat harvest. Receive small test injections behind each ear for later analysis. Provide data on demographics and medical conditions for correlation with outcomes.

Research Team

Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

Principal Investigator

Director, Operations and Administration

J. Peter Rubin

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for wounded service members and veterans with post-traumatic craniofacial deformities. Participants must be willing to undergo two fat grafting procedures: one with fresh fat and another with previously harvested and cryopreserved fat. They should also agree to provide medical and demographic data.

Inclusion Criteria

Willing and able to comply with follow up examinations, including radiographic studies (i.e. CT scans)

I have enough donor fat tissue for grafting and storage.

My facial injury can be treated with fat grafting.

Exclusion Criteria

I have a condition that increases my risk of bleeding.

I am under 18 years old.

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants undergo an initial fat grafting procedure using freshly harvested adipose tissue.

1 day

1 visit (in-person)

Second Treatment

Participants receive a second fat grafting procedure 3 months after the first, using cryopreserved adipose tissue.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the second treatment.

3 months

Multiple visits (in-person)

Treatment Details

Interventions

• Autologous Cryopreserved Fat Grafting
• Autologous Fresh Fat Grafting

Trial Overview The study tests a two-stage facial reconstruction technique using autologous (from the patient) fat grafts. The first stage involves fresh fat grafting, followed by a second treatment after 3 months using cryopreserved (-80°C) fat, aiming to improve tissue regeneration and appearance.

Participant Groups

Group I: Clinical Intervention Experimental Treatment 1 Intervention

The therapeutic intervention is a two stage surgical procedure (with a third stage biopsy for research purposes in this trial) in which a primary traumatic or post-surgical craniofacial deformity is treated first with autologous fat grafting using freshly harvested adipose tissue. A second fat grafting procedure is performed at 3.0 months after the first procedure using autologous adipose tissue that had been cryopreserved during the first procedure.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Armed Forces Institute of Regenerative Medicine

Collaborator

Trials

7

Recruited

220+

Findings from Research

A review of 396 patients undergoing autologous fat grafting from January 2015 to July 2018 showed that this technique is effective for volumization of the breasts and face, with an average of 124.4 grams of fat grafted per procedure.

While 27.8% of patients experienced complications, most were minor, and no life-threatening issues were reported, indicating that fat grafting is generally safe despite some risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Fat Grafting: An Institutional Retrospective Review. Fang, HA., Soto, E., Pigg, R., et al.[2023]

Doppler-ultrasound (DUS) imaging was successfully used in a study of 20 female patients (average age 57.9 years) to safely guide the harvesting and injection of autologous fat for facial lipofilling, helping to visualize and avoid the temporal artery during the procedure.

The study reported only one case of edema and nodules, indicating a favorable safety profile for DUS-guided lipofilling, suggesting that DUS should be considered an essential part of the procedure to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. Kadouch, J., Schelke, LW., Swift, A.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Fat Grafting to Improve Results of Facelift: Systematic Review of Safety and Effectiveness of Current Treatment Paradigms. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Safety of Fat Grafting: An Institutional Retrospective Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Current Thoughts on Fat Grafting: Using the Evidence to Determine Fact or Fiction. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Integrated autologous fat graft in face recontouring]. [2019]

5. Bulgaria pubmed.ncbi.nlm.nih.gov

Our experience in the application of lipofilling. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Arterial Embolism After Facial Fat Grafting: A Systematic Literature Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Fat Embolism After Autologous Facial Fat Grafting. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Autogenous Fat Grafting to the Breast and Gluteal Regions: Safety Profile Including Risks and Complications. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Syringe aspiration and fat concentration: a simple technique for autologous fat injection. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Autologous fat grafting]. [2018]