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Clinical Trial: Facial Fat Grafting

ClinicalTrials.gov ID: NCT05482425

Title: Autologous Facial Fat Grafting Study

PI: J. Peter Rubin, MD

Description:  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.

Primary & Secondary Objectives:  Primary Objective: Evaluate changes in skin appearance between groups, including texture and pigmentation, following autologous fat grafting using two different preparations (washed versus unwashed).

Secondary Objectives: Assess the following outcomes following autologous fat grafting using two different preparations (washed versus unwashed).

  1. Assess rates of infection, local inflammation, and other adverse reactions between groups
  2. Compare the biological characterizations of the fat graft used between two preparations across subjects.
  3. Compare Patient Reported Outcomes between washed and unwashed groups
  4. Assess skin rejuvenation characteristics based on blinded expert grading of VISIA CR and VECTRA 3D images between washed and unwashed groups.

Measurement/Outcomes: 

  1. Clinical assessment to include cutometer measurements of skin rejuvenation efficacy and questionnaires to include FWAS, SQA, SSA, SESS, GAIS and subject self-assessment will be used to assesses skin quality. (Baseline, Weeks 4, 12, 24, 36, and 52)
  2. Investigator’s overall assessment of fat grafting results, supported by blinded evaluator’s imaging assessments. (Baseline/pre fat graft injection, Weeks 4, 12, 24, 36, and 52)
  3. Safety: Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent signature date until the end of the study.

Numbers of subjects to undergo intervention: 26

For more information, please contact:

Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM 
Director, Operations and Administration
Center for Innovation in Restorative Medicine (CIRM)
University of Pittsburgh, Department of Plastic Surgery
6B Scaife Hall, room 664
3550 Terrace Street 
Pittsburgh, PA 15261 
Phone: 412-648-9207  
simonpa@upmc.edu​