Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
Fat grafting represents a technique with great potential to improve outcomes in minimally
 invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and
 minimally invasive technique over decades of widespread practice in plastic surgery. In our
 current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9
 subjects without adverse event and all have had a significant improvement. Since all methods
 of treatment and evaluation are the same in this study, we will be able to use the data in
 our prior study as additional control data.

 We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts
 will enable successful restoration of tissue volume and craniofacial form. Additionally, we
 hypothesize that the results will be durable and subject quality of life improved.

 Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to
 this single center University of Pittsburgh site research study.
Facial trauma injuries, especially those sustained in military combat and severe automobile
 crashes, are characterized by destruction of bone and soft tissue anatomy. While the bony
 skeleton can often be reconstructed, the overlying soft tissue is difficult to restore.

 Importantly, it is the structure of the soft tissue that imparts the normal human form, and
 adequate reconstruction of soft tissue defects allows trauma victims to reintegrate into
 society. Accepted procedures for soft tissue reconstruction of the face involve tissue flap
 reconstruction procedures and autologous fat grafting. Tissue flap operations are extensive,
 often including microvascular surgery, and do not precisely correct the deformities. Fat
 grafting is a less invasive technique that allows for more precise shaping of the
 reconstructed tissues. However, autologous fat grafts may undergo resorption that can affect
 the appearance of the reconstruction over time. The degree of change in appearance after fat
 grafting has not been well studied for facial trauma patients.

 We hypothesize that subjects who have successfully completed participation in the study
 (PRO09060101) and experienced graft resorbtion will have improved outcomes with an additional
 fat graft treatment. We anticipate that additional fat graft treatment will fully restore the
 facial features and overcome fat loss from the initial fat graft treatment. Additionally, we
 hypothesize that the cellular properties of the fat precursor cells (preadipocytes) may
 correlate with fat graft retention
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 lipaspirate in order to obtain symmetry.

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

 7. Have completed participation in IRB# PRO09060101.

 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. Systemic disease that would render the fat harvest and injection procedure, along with
 associated anesthesia, unsafe to the patient.

 8. Pregnancy

 9. Subjects with Schizophrenia, Bipolar Disorder. (Subjects who are found to be stable on
 medication and receive psychiatric clearance could be eligible for study participation
 per the Physician's discretion.)