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NCT01564524 · ClinicalTrials.gov registry record
Effect of Concentrating Endogenous Stromal Cells in the Fat Graft
A clinical trial, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- 3
- Enrollment target
NCT01564524: Clinical Trial study, sponsored by University of Pittsburgh.
NCT01564524 is a clinical trial that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01564524 was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
Traumatic facial injuries, especially those sustained in military combat, are characterized by destruction of bone and soft tissue. While the bony structures of the face can be reconstructed, it is difficult to return the soft tissue back to its original form. Many times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat is taken from areas throughout the body, usually the thighs or abdomen, with a small liposuction tube. The fat is then transferred into the area that has lost volume or fullness. The fullness of the soft tissue area may decrease over time because the transferred fat can be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft procedure. We are conducting this research study to help us improve the surgical treatment of people who have suffered facial soft tissue loss as a result of trauma. The goal of this research study is to see how each person's fat grafts will maintain the fat over time and to measure the quality of life during a 9 month post-surgical follow-up period. The total duration of participation is approximately 11 months. In this study, we will concentrate the fat in the fat grafting procedure to determine whether this process will maintain the fat over time. The areas treated with enhanced fat grafts will be compared with areas treated with standard of care fat grafts. At least two areas of your face will be treated with fat grafts, (standard of care fat grafts and concentrated fat grafts).
Primary Outcome
Facial appearance and persistence of graft volume will be assessed using aesthetic grading scales, state of the art 3D photography, and high resolution CT scanning with 3D reconstruction. Subjects will be followed for 9 months after graft procedure to define long term outcomes.
Interventions
- PROCEDURE Fat graft surgical procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-08 |
Why NCT01564524 stopped before completion
NCT01564524 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Fat graft surgical procedure is the first listed.
NCT01564524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01564524 about?
NCT01564524 is a clinical study titled "Effect of Concentrating Endogenous Stromal Cells in the Fat Graft". Traumatic facial injuries, especially those sustained in military combat, are characterized by destruction of bone and soft tissue. While the bony structures of the face can be reconstructed, it is difficult to return the soft tissue back to its original form. Many times, fat grafting, a common cosm...
What is the current status of trial NCT01564524?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2011-04. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01564524?
The interventions under investigation include: Fat graft surgical procedure (PROCEDURE).
Who is sponsoring clinical trial NCT01564524?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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