At a glance
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Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
In Brief
A clinical study evaluating Fat Grafting, General Anesthesia, and 2 other interventions for Facial Injuries. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Fat Grafting is a procedure that involves moving a person's own fat from an area of the body where it is less needed to another area of the body to improve its appearance. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost volume or fullness due to aging, trauma, surgery, birth defects, or other causes.
A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.
The plastic surgeon, will use small narrow tube-like instruments called cannulas, will remove fat from various places throughout the body (commonly the abdomen and thighs). The plastic surgeon will then use the Coleman cannulas (specialized smaller cannulas with varied shapes and tip sizes specifically made to deliver smaller amounts of fat) to fill the desired area.
The processing of the fat graft material is done using a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component.