A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury (BTI)
Injuries resulting in facial trauma are common, and can have devastating consequences on your quality of life. While the facial bones can often be reconstructed, physicians strive to find better ways to accurately restore injured facial features.
In this clinical trial funded by the Department of Defense, the investigators are evaluating how effectively fat grafting can restore facial features, and how the filling effect of the fat graft lasts over time in participants with visible facial injuries. All procedures for this research study will be performed at the University of Pittsburgh Medical Center.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Structural Fat Grafting for Craniofacial Trauma|
- The volume and contour of the fat graft site. [ Time Frame: as assessed 7-21 days, 3 months and 9 months post op. ] [ Designated as safety issue: Yes ]
- Quality of life measures [ Time Frame: as assessed by 7-21 days, 3 months and 9 months post op. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
During the Fat grafting reconstructive surgery the PI and /or Co-investigator will obtain a portion of the fat (lipoaspirate) approximately 20-30 ccs specimen will be collected as a research sample. If the participant refuses to give consent for this sample, they will not be able to participate in the main clinical trial. The sample will remain under the oversight of Plastic Surgery Lab Co-Investigator and examined for cellular information in the Plastic surgery lab at the University of Pittsburgh.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
The purpose of this research is to evaluate how well the filling effect of the fat remains over time. A person's own fat may be used to improve the appearance of the body by moving it from an area where it is less needed. This is called fat grafting, and it is a common procedure, performed approximately 65,000 times by plastic surgeons in the United State last year. 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. Typically, the transferred fat results in an increase in volume of the body site being treated.
Fat grafting is a minimally invasive surgical procedure in which a person's own fat may be used to improve the appearance of the body by moving it from an area where it is less needed. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost shape or fullness due to injury. This procedure is performed through very small incisions that allow a hollow tube to pass through.
Fat grafting is a common cosmetic and reconstructive procedure. It was performed approximately 65,000 times by plastic surgeons in the United States last year. Typically, the transferred fat results in an increase in volume and shape of the body site being treated. The investigators believe this clinical technique of fat grafting could be of significant benefit to patients with facial injuries. The fat grafting procedure being performed in this trial is considered to be research, but not an experimental procedure.
|Contact: Carlynn Jackson Graves, BSfirstname.lastname@example.org|
|Contact: Nancy E McCormick, MSemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Carlynn R. Jackson Graves, BS 412-864-2581 firstname.lastname@example.org|
|Contact: Nancy E McCormick, MS 412-864-2583 email@example.com|
|Principal Investigator: J. Peter Rubin, MD|
|Sub-Investigator: Kacey Marra, PhD|
|Sub-Investigator: Christine Fisher, MD|
|Sub-Investigator: Barton Branstetter, MD|
|Sub-Investigator: Gretchen Haas, PhD|
|Sub-Investigator: Patsy Simon, RN, BS|
|Sub-Investigator: Carlynn Jackson, BS|
|Sub-Investigator: Nancy McCormick, BS, MS|
|Sub-Investigator: Diana Ross, MSN, RN|
|Sub-Investigator: Tara Grahavoc, MD|
|Sub-Investigator: Diana Mermon, MS|
|Sub-Investigator: Chad Purnell, BS|
|Sub-Investigator: Ronald Bossert, MD|
|Sub-Investigator: Sydney Coleman, MD|
|Sub-Investigator: Spencer A Brown, PhD|
|Principal Investigator:||Joseph Peter Rubin, MD||Associate Professor of Plastic Surgery at the University of Pittsburgh, Faculty appointment-McGowan Institute of Regenerative Medicine|