A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury

The purpose of this research is to evaluate how well the filling effect of the fat remains
over time. A person's own fat may be used to improve the appearance of the body by moving it
from an area where it is less needed. This is called fat grafting, and it is a common
procedure, performed approximately 65,000 times by plastic surgeons in the United State last
year. The fat is usually taken from the thighs or abdomen with a small liposuction tube and
then moved to an area that has lost volume or fullness due to aging, trauma, surgery, birth
defects, or other causes. Typically, the transferred fat results in an increase in volume of
the body site being treated.

Fat grafting is a minimally invasive surgical procedure in which a person's own fat may be
used to improve the appearance of the body by moving it from an area where it is less
needed. The fat is usually taken from the thighs or abdomen with a small liposuction tube
and then moved to an area that has lost shape or fullness due to injury. This procedure is
performed through very small incisions that allow a hollow tube to pass through.

Fat grafting is a common cosmetic and reconstructive procedure. It was performed
approximately 65,000 times by plastic surgeons in the United States last year. Typically,
the transferred fat results in an increase in volume and shape of the body site being
treated. The investigators believe this clinical technique of fat grafting could be of
significant benefit to patients with facial injuries. The fat grafting procedure being
performed in this trial is considered to be research, but not an experimental procedure.

Inclusion Criteria:

1. Aged 18 years or older and able to provide informed consent

2. Have suffered injury resulting in craniofacial volume defects which could be treated
with a graft volume of between 5 and 150 cc of lipoaspirate

3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that
acute edema is resolved

4. Volume defects are covered by intact skin and do not communicate with oral cavity or
sinuses

5. 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 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
contralateral region with lipoaspirate in order to obtain symmetry.

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

Exclusion Criteria:

1. Age less than 18 years

2. Inability to provide informed consent

3. 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).

4. Active infection anywhere in the body

5. Diagnosed with cancer within the last 12 months and /or presently receiving
chemotherapy or radiation treatment

6. Known coagulopathy

7. Pregnancy -