Effect of Concentrating Endogenous Stromal Cells in the Fat Graft

Stopped early

Conditions studied: Facial Injuries, Adipose Tissue

In brief

Traumatic facial injuries, especially those sustained in military combat, are characterized by destruction of bone and soft tissue. While the bony structures of the face can be reconstructed, it is difficult to return the soft tissue back to its original form. Many times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat is taken from areas throughout the body, usually the thighs or abdomen, with a small liposuction tube. The fat is then transferred into the area that has lost volume or fullness. The fullness of the soft tissue area may decrease over time because the transferred fat can be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft procedure. We are conducting this research study to help us improve the surgical treatment of people who have suffered facial soft tissue loss as a result of trauma. The goal of this research study is to see how each person's fat grafts will maintain the fat over time and to measure the quality of life during a 9 month post-surgical follow-up period. The total duration of participation is approximately 11 months. In this study, we will concentrate the fat in the fat grafting procedure to determine whether this process will maintain the fat over time. The areas treated with enhanced fat grafts will be compared with areas treated with standard of care fat grafts. At least two areas of your face will be treated with fat grafts, (standard of care fat grafts and concentrated fat grafts).

Key facts

Study ID: NCT01564524
Run by: University of Pittsburgh
People needed: 3
Starts: 2011-04-01
Expected to finish: 2013-08-01
Last updated by the study team: 2016-10-25

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Aged 18 years or older and able to provide informed consent
Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate
Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
The three dimensional geometry of the volume defects would allow for treatment with lipoaspirate injection so that at least two distinct treated areas could be discerned on gross examination and radiographically (e.g. treated regions are on opposite sides of the face, on lower face versus upper face, or separated by a bony landmark such as zygoma. This would include the ability to treat an uninjured regions with fat grafts in order to obtain symmetry or balance.
Willing and able to comply with follow up examinations, including radiographic studies

You may not qualify if…

Age less than 18 years
Inability to provide informed consent
Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: presence of such a defect in the setting of another defect(s) that meets treatment criteria will not exclude the patient from participating).
Active infection anywhere in the body
Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
Known coagulopathy
Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
Pregnancy
Diagnosis of Schizophrenia or Bipolar Disorder

Where it is running

University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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