Status:
COMPLETED
Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
United States Department of Defense
Conditions:
Facial Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 2...
Detailed Description
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. Ove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02267187
Start Date
October 22 2014
End Date
June 21 2017
Last Update
July 24 2018
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213