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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeat Facial fat grafting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repeat Fat grafting | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Facial Volume Score | 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. | assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Serial Computed Tomography Imaging | serial computed tomography images were collected to evaluate the volume of the defect | assessed at 7-21 days, 3 months and 9 months post op. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Rubin, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16936551 | Background | Moseley TA, Zhu M, Hedrick MH. Adipose-derived stem and progenitor cells as fillers in plastic and reconstructive surgery. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):121S-128S. doi: 10.1097/01.prs.0000234609.74811.2e. | |
| 17653684 | Background | Cardenas JC, Carvajal J. Refinement of rhinoplasty with lipoinjection. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):501-5. doi: 10.1007/s00266-006-0136-2. Epub 2007 Jul 25. |
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It is the Principal Investigator's intention to make stored samples and subject de-identified information available to secondary investigators after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.
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Recruitment will come from subjects who have successfully completed IRB# PRO09060101 entitled "Structural Fat Grafting for Craniofacial Trauma". These subjects have expressed a strong desire to participate in this study and have been asked to sign the Research Registry IRB#PRO07050333.
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| ID | Title | Description |
|---|---|---|
| FG000 | Repeat Facial Fat Grafting | Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Repeat Facial Fat Grafting | 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. We treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 18 years or older |
| 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 | Facial Volume Score | 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. | Posted | Mean | Standard Deviation | units on a scale | assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, 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 | Repeat Facial Fat Grafting | Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time. |
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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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|
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| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Serial computer tomography imaging | Count of Participants | Participants |
|
facial volume score at 7-21 days post-operation
| OG002 | Facial Volume Score at 3 Month PO | facial volume score at 3 months post-operation |
| OG003 | Facial Volume Score at 9 Months PO | facial volume score at 3 months post-operation |
|
|
| Secondary | Serial Computed Tomography Imaging | serial computed tomography images were collected to evaluate the volume of the defect | Posted | Mean | Standard Deviation | volume, mL | assessed at 7-21 days, 3 months and 9 months post op. |
|
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| 0 |
| 5 |
| 5 |
| 5 |
| swelling | Surgical and medical procedures |
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| pain | Surgical and medical procedures |
|
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