Adipose Tissue Clinical Trial
Official title:
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
;
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