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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat Grafting | Experimental | Twenty (20) subjects who have had severe facial trauma, 18 years of age and older enrolled to clinical trial will receive Fat grafting intervention procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat Grafting | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume | fat graft volume | 3 months and 9 months post op. |
| Measure | Description | Time Frame |
|---|---|---|
| SWAP, COPE and CSQ-8 | three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Rubin, MD | Associate Professor of Plastic Surgery at the University of Pittsburgh, Faculty appointment-McGowan Institute of Regenerative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16936550 | Background | Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7. | |
| 16230558 | Background | Burnouf M, Buffet M, Schwarzinger M, Roman P, Bui P, Prevot M, Deleuze J, Morini JP, Franck N, Gorin I, Dupin N. Evaluation of Coleman lipostructure for treatment of facial lipoatrophy in patients with human immunodeficiency virus and parameters associated with the efficiency of this technique. Arch Dermatol. 2005 Oct;141(10):1220-4. doi: 10.1001/archderm.141.10.1220. |
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It is the Principal Investigator's intention to make stored samples and subject information de-identified available to secondary investigators (investigators not listed on the front page of this consent document) after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fat Grafting | fat grafting for facial trauma |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fat Grafting | Fat Grafting for facial trauma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume | fat graft volume | Posted | Mean | Standard Deviation | milliliters | 3 months and 9 months post op. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fat Grafting | fat grafting for facial trauma |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bruising | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Peter Rubin | University of Pittsburgh | 412-624-9703 | rubipj@upmc.edu |
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| ID | Term |
|---|---|
| D005151 | Facial Injuries |
| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| as assessed at baseline, 7-21 days, 3 months and 9 months post op. |
| 17255689 | Background | Kaufman MR, Bradley JP, Dickinson B, Heller JB, Wasson K, O'Hara C, Huang C, Gabbay J, Ghadjar K, Miller TA. Autologous fat transfer national consensus survey: trends in techniques for harvest, preparation, and application, and perception of short- and long-term results. Plast Reconstr Surg. 2007 Jan;119(1):323-331. doi: 10.1097/01.prs.0000244903.51440.8c. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| volume | Mean | Standard Deviation | milliliters |
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| tissue thickness | Mean | Standard Deviation | milliliters |
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| Secondary | SWAP, COPE and CSQ-8 | three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction. | Posted | Mean | Standard Deviation | units on a scale | as assessed at baseline, 7-21 days, 3 months and 9 months post op. |
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| 0 |
| 20 |
| 20 |
| 20 |
| swelling at injection site | Surgical and medical procedures |
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| warmth | Vascular disorders |
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| redness at injection site | Surgical and medical procedures |
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| COPE |
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| CSQ-8 |
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