Facial Fat Grafting for Skin Appearance

Overseen By Anne Lindsey, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Aspirin, Warfarin, Corticosteroids, others

Disqualifiers: Pregnancy, Active infection, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

26 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that individuals taking substances affecting bleeding time or impairing the immune system may be excluded. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Autologous facial fat graft injection for improving skin appearance?

Research shows that autologous fat grafting is effective for restoring volume in the aging face and is commonly used in facial rejuvenation. It is considered a safe and lasting method for soft tissue augmentation, helping to improve facial appearance. ^{1 2 3 4 5}

Is facial fat grafting generally safe for humans?

Facial fat grafting is generally considered safe, but there are risks of serious complications like arterial embolism (blockage of blood vessels) and fat embolism (fat entering the bloodstream), which can be severe or even fatal. Other complications include prolonged swelling, irregularities, and in rare cases, infections. The overall complication rate is not well-defined, but it can range widely, and more research is needed to fully understand the risks. ^{2 6 7 8 9}

How is autologous facial fat graft injection different from other treatments for improving skin appearance?

Autologous facial fat grafting is unique because it uses a person's own fat, harvested from another part of their body, to enhance facial volume and improve skin appearance, reducing the risk of foreign body reactions. Unlike synthetic fillers, this method can provide more natural and lasting results, although it may require multiple sessions for optimal effects. ^{2 4 10 11 12}

What is the purpose of this trial?

The goal of this study is to specifically examine changes in facial skin appearance after facial fat grafting with autologous fat tissue that has either been washed with sterile saline before injecting, or left unwashed. This will be testing two variations of a standard of care surgical procedure, in two cohorts of subjects. One group will receive washed fat, and one group will receive unwashed fat, to both sides of the face. There are no experimental devices, drugs, or biological agents being used in this study. All fat tissue is autologous from the subjects treated. Significance: This study will provide evidence that may directly impact clinical practice for a common procedure in plastic surgery. Regardless of whether the null hypotheses is accepted or rejected, the data will be of direct clinical use and impact practice in the operating room.

Research Team

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

Principal Investigator

University of Pittsburgh

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Healthy women aged 35-70 with moderate to severe facial aging signs, such as wrinkles and uneven skin tone. They must be willing to follow study procedures, not pregnant or breastfeeding, have a Fitzpatrick Skin Type Scale score <3, and avoid certain cosmetic treatments for 6 months. Exclusions include recent cosmetic procedures on the face, contraindications to fat grafting like infections at harvest site, bleeding disorders, uncontrolled diseases affecting safety or healing.

Inclusion Criteria

My walking ability is moderately affected or worse.

I can provide enough fat tissue for donation (up to 1 liter).

I understand and can give consent for my treatment.

Exclusion Criteria

I have not taken Accutane in the last year.

I have a history of immune system problems or healing issues.

I haven't had facial cosmetic procedures like laser, Botox, or fillers in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Autologous fat graft injections performed on Day 0 after eligibility determination and baseline data collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in facial skin characteristics and safety over a 12-month period

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Autologous facial fat graft injection

Trial Overview The trial is testing the effects of autologous facial fat grafting on skin appearance by comparing two methods: one using washed fat tissue and another using unwashed fat. This non-experimental procedure involves injecting patients' own harvested fat into their faces to see if there's a difference in outcomes between the two techniques.

Participant Groups

Group I: Autologous facial fat graft injection-unwashed fat Experimental Treatment 1 Intervention

Unwashed fat injected into both the left and right sides of the face.

Group II: Autologous facial fat graft injection- washed fat Experimental Treatment 1 Intervention

Washed fat injected into both the left and right sides of the face.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

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. England pubmed.ncbi.nlm.nih.gov

Periorbital lipogranuloma: a previously unknown complication of autologous fat injections for facial augmentation. [2011]

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

Fat Grafting in Patients With Extensive Unilateral Facial Deficiency: Three-Dimensional Computer-Assisted Planning, Implementation, and Outcome Assessment. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Comparison of fat maintenance in the face with centrifuge versus filtered and washed fat. [2022]

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

Autologous Fat Transfer Harvest-site Complications: Incidence, Risk Factors, and Management. [2023]

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

Fat Embolism After Autologous Facial Fat Grafting. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Facial Fat Grafting (FFG): Worth the Risk? A Systematic Review of Complications and Critical Appraisal. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

[Autologous fat grafting]. [2018]

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

Massive Cerebral Infarction Following Facial Fat Injection. [2017]