Facial Injuries Clinical Trial
— BTI++Official title:
Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
Verified date | June 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine the impact of the fat grafting procedure on facial appearance and
quality of life over time by precisely measuring soft tissue volume with CT scans, assessing
appearance with 2D and 3D photography and standard photography and evaluating quality of life
through various validated psychosocial measures. This study will be a very important
evaluation of the effectiveness of this therapy, and will help guide clinicians in applying
this technique. Additionally, laboratory testing of the injected fat material will be
performed so that the results may be correlated with clinical outcomes in the future.
The study endpoints include the analysis of the graft site via study procedures at different
time points, the comparison of cotton rolling to centrifugation method of autologous fat
grafting, as well as the correlation of cell behavior of the laboratory assays with clinical
outcomes.
Status | Completed |
Enrollment | 15 |
Est. completion date | June 21, 2017 |
Est. primary completion date | June 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. | Assessed at 7-21 days, 3 months, 9 months | ||
Primary | Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. | Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance. | screen, 7-21 days, 3, and 9 months post-operative | |
Secondary | Assessment of Cellular Properties of the Cells Within the Fat Graft | Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft. | Assessed at time of operative procedure |
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