N/A
N=15
Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
Facial Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02267187 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. — 11.4; 7.4; 6.5 milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fat Grafting (Procedure); General Anesthesia (Drug); Coleman Cannulas (Device); Tefla non-adherent gauze pad (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. |
11.4; 7.4; 6.5 | — |
| PRIMARY Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. |
1.0; 2.6; 2.2; 2.2 | — |
| SECONDARY Assessment of Cellular Properties of the Cells Within the Fat Graft |
27.9 | — |
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 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02267187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.