Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (BTIPlusUp)
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|ClinicalTrials.gov Identifier: NCT01822301|
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : May 12, 2017
Last Update Posted : July 11, 2017
Fat grafting represents a technique with great potential to improve outcomes in minimally invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and minimally invasive technique over decades of widespread practice in plastic surgery. In our current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9 subjects without adverse event and all have had a significant improvement. Since all methods of treatment and evaluation are the same in this study, we will be able to use the data in our prior study as additional control data.
We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts will enable successful restoration of tissue volume and craniofacial form. Additionally, we hypothesize that the results will be durable and subject quality of life improved.
Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to this single center University of Pittsburgh site research study.
|Condition or disease||Intervention/treatment||Phase|
|Facial Injuries Adipose Tissue||Procedure: Repeat Fat grafting||Not Applicable|
Facial trauma injuries, especially those sustained in military combat and severe automobile crashes, are characterized by destruction of bone and soft tissue anatomy. While the bony skeleton can often be reconstructed, the overlying soft tissue is difficult to restore.
Importantly, it is the structure of the soft tissue that imparts the normal human form, and adequate reconstruction of soft tissue defects allows trauma victims to reintegrate into society. Accepted procedures for soft tissue reconstruction of the face involve tissue flap reconstruction procedures and autologous fat grafting. Tissue flap operations are extensive, often including microvascular surgery, and do not precisely correct the deformities. Fat grafting is a less invasive technique that allows for more precise shaping of the reconstructed tissues. However, autologous fat grafts may undergo resorption that can affect the appearance of the reconstruction over time. The degree of change in appearance after fat grafting has not been well studied for facial trauma patients.
We hypothesize that subjects who have successfully completed participation in the study (PRO09060101) and experienced graft resorbtion will have improved outcomes with an additional fat graft treatment. We anticipate that additional fat graft treatment will fully restore the facial features and overcome fat loss from the initial fat graft treatment. Additionally, we hypothesize that the cellular properties of the fat precursor cells (preadipocytes) may correlate with fat graft retention
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
|Experimental: Repeat Facial fat grafting||
Procedure: Repeat Fat grafting
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 considered a standard of care procedure in plastic surgery. In brief, fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula in the operating room. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the facial deformity using specialized injection cannulas. In this study, we will treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) with be used for comparison.
- Facial Volume Score [ Time Frame: assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op ]the facial volume and appearance grading scale evaluates each aesthetic region in the face based on both physical examination and 3D photography by the clinician. scale ranges from 1-3 where a score of 1 indicates an obvious contour defect; 2 shows a noticeable improvement in contour but not sufficient to impart a normal appearance; 3 represents a normal appearance and/or close approximation with a normal uninjured contralateral structure.
- Serial Computed Tomography Imaging [ Time Frame: assessed at 7-21 days, 3 months and 9 months post op. ]serial computed tomography images were collected to evaluate the volume of the defect
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): NCT01822301
|United States, Pennsylvania|
|Unversity of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Joseph P Rubin, MD||University of Pittsburgh|