Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material

Clinical use of autologous fat grafting in humans was described as early as 1893, when Neuber
published his report of transferring multiple small particles of fat to fill a soft tissue
depression. Over the past three decades, autologous fat grafting has become a common
procedure in clinical plastic surgery, and is also employed by clinicians in other
specialties. The refinement of liposuction techniques in the 1980's made it possible to
harvest the adipose grafts with low risk and without the need for a significant incision. The
liposuction aspirate could simply be reinjected at a different site. Specialized equipment
has been developed for fat grafting and is commercially available from a number of sources.
The American Society of Plastic Surgeons 2007 procedural statistics show that over 65,000 fat
grafting procedures were performed in the United States (www.plasticsurgery.org) during the
previous year.

Fat grafting may represent a superior method of facial reconstruction after severe trauma,
but the results can be impacted by resorption of fat volume over time. The specific aims of
the study are:

1. Assess facial appearance and soft tissue volume before and after autologous fat grafting
using CT scans and 3D photography.

2. Assess cellular properties of the cells within the fat graft

3. Comparison of cotton rolling to centrifugation method of autologous fat grafting

4. Measure of quality of life in patients before and after autologous fat grafting using
validated psychosocial measures.

Ten (10) subjects 18 years of age and older will be enrolled to this trial.

Inclusion Criteria:

- Aged 18 years or older and able to provide informed consent

- Who are post injury and/or post surgery (e.g. tx of aneurism, intercranial bleed, and
tumor resections that do not involve radiation and would be analogous to trauma
population requiring craniotomy) resulting in craniofacial volume defect which could
be treated with a graft volume of between 5 and 150 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 that in a manner that at least two distinct treated areas could
be discerned on gross examination

- Willing and able to comply with follow up examinations, including radiographic studies

Exclusion Criteria:

- 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

- Pregnancy

- Subjects with an Axis I DSM-IV diagnosis (e.g., Schizophrenia, Bipolar disorder) who
are found to be clinically (i.e. medically) unstable at baseline. Individuals who
manifest either: 1) evidence of currently active alcohol or psychoactive drug abuse or
dependence on the SCID interview, or 2) a GAF score of 40 or lower due to any acute
psychiatric symptomatology (e.g. suicidality, psychosis, severe depression or mania)
will be reviewed by the Co-I for Psychosocial Assessment with the PI for determination
of possible medical instability. Final determination of medically unstable status will
be made by the PI on the basis of overall medical status and appropriateness for
medical procedures; the patient may be considered ineligible for study participation
per the Physician's discretion