Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material (BTI++)
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|ClinicalTrials.gov Identifier: NCT02267187|
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : May 17, 2018
Last Update Posted : July 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Facial Injuries||Procedure: Fat Grafting Drug: General Anesthesia Device: Coleman Cannulas Other: Tefla non-adherent gauze pad||Not Applicable|
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. Over the past three decades, autologous fat grafting has become a common procedure in clinical plastic surgery, and is also employed by clinicians in other specialties. The refinement of liposuction techniques in the 1980's made it possible to harvest the adipose grafts with low risk and without the need for a significant incision. The liposuction aspirate could simply be reinjected at a different site. Specialized equipment has been developed for fat grafting and is commercially available from a number of sources. The American Society of Plastic Surgeons 2007 procedural statistics show that over 65,000 fat grafting procedures were performed in the United States (www.plasticsurgery.org) during the previous year.
Fat grafting may represent a superior method of facial reconstruction after severe trauma, but the results can be impacted by resorption of fat volume over time. The specific aims of the study are:
- Assess facial appearance and soft tissue volume before and after autologous fat grafting using CT scans and 3D photography.
- Assess cellular properties of the cells within the fat graft
- Comparison of cotton rolling to centrifugation method of autologous fat grafting
- Measure of quality of life in patients before and after autologous fat grafting using validated psychosocial measures.
Ten (10) subjects 18 years of age and older will be enrolled to this trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material|
|Actual Study Start Date :||October 22, 2014|
|Actual Primary Completion Date :||June 21, 2017|
|Actual Study Completion Date :||June 21, 2017|
Experimental: Fat Graftting
For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.
Procedure: Fat Grafting
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.
Drug: General Anesthesia
A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.
Device: Coleman Cannulas
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.
Other: Tefla non-adherent gauze pad
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.
- Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. [ Time Frame: Assessed at 7-21 days, 3 months, 9 months ]
- Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. [ Time Frame: 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.
- Assessment of Cellular Properties of the Cells Within the Fat Graft [ Time Frame: Assessed at time of operative procedure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267187
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Joseph P Rubin, MD||Professor of Plastic Surgery at the University of Pittsburgh|