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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study will examine the impact of the fat grafting procedure on facial appearance and quality of life over time by precisely measuring soft tissue volume with CT scans, assessing appearance with 2D and 3D photography and standard photography and evaluating quality of life through various validated psychosocial measures. This study will be a very important evaluation of the effectiveness of this therapy, and will help guide clinicians in applying this technique. Additionally, laboratory testing of the injected fat material will be performed so that the results may be correlated with clinical outcomes in the future.
The study endpoints include the analysis of the graft site via study procedures at different time points, the comparison of cotton rolling to centrifugation method of autologous fat grafting, as well as the correlation of cell behavior of the laboratory assays with clinical outcomes.
Clinical use of autologous fat grafting in humans was described as early as 1893, when Neuber published his report of transferring multiple small particles of fat to fill a soft tissue depression. Over the past three decades, autologous fat grafting has become a common procedure in clinical plastic surgery, and is also employed by clinicians in other specialties. The refinement of liposuction techniques in the 1980's made it possible to harvest the adipose grafts with low risk and without the need for a significant incision. The liposuction aspirate could simply be reinjected at a different site. Specialized equipment has been developed for fat grafting and is commercially available from a number of sources. The American Society of Plastic Surgeons 2007 procedural statistics show that over 65,000 fat grafting procedures were performed in the United States (www.plasticsurgery.org) during the previous year.
Fat grafting may represent a superior method of facial reconstruction after severe trauma, but the results can be impacted by resorption of fat volume over time. The specific aims of the study are:
Ten (10) subjects 18 years of age and older will be enrolled to this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat Graftting | Experimental | For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental 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 known as a filler providing an accurate means to restoring facial soft tissue structure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat Grafting | Procedure | Fat Grafting is a procedure that involves moving a person's own fat from an area of the body where it is less needed to another area of the body to improve its appearance. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. | Assessed at 7-21 days, 3 months, 9 months | |
| Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. | Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance. | screen, 7-21 days, 3, and 9 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Cellular Properties of the Cells Within the Fat Graft | Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft. | Assessed at time of operative procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Rubin, MD | Professor of Plastic Surgery at the University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985369 | Derived | Bourne DA, Bliley J, James I, Donnenberg AD, Donnenberg VS, Branstetter BF 4th, Haas GL, Radomsky E, Meyer EM, Pfeifer ME, Brown SA, Marra KG, Coleman S, Rubin JP. Changing the Paradigm of Craniofacial Reconstruction: A Prospective Clinical Trial of Autologous Fat Transfer for Craniofacial Deformities. Ann Surg. 2021 May 1;273(5):1004-1011. doi: 10.1097/SLA.0000000000003318. |
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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 | Cotton Rolling Fat Grafting | For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental 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 known as a filler providing an accurate means to restoring facial soft tissue structure. The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cotton Rolling Fat Grafting | For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental 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 known as a filler providing an accurate means to restoring facial soft tissue structure. The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. | Posted | Mean | Standard Deviation | milliliters | Assessed at 7-21 days, 3 months, 9 months |
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7-21 days, 3 months, 9 months post-operatively.
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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 | Cotton Rolling Fat Grafting | For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental 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 known as a filler providing an accurate means to restoring facial soft tissue structure. The processing of the fat graft material is done using a cotton rolling technique via a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patsy Simon | University of Pittsburgh | 412-648-9207 | simonpa@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2017 | Apr 18, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2017 | Apr 18, 2018 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| General Anesthesia | Drug | A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure. |
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| Coleman Cannulas | Device | The plastic surgeon, will use small narrow tube-like instruments called cannulas, will remove fat from various places throughout the body (commonly the abdomen and thighs). The plastic surgeon will then use the Coleman cannulas (specialized smaller cannulas with varied shapes and tip sizes specifically made to deliver smaller amounts of fat) to fill the desired area. |
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| Tefla non-adherent gauze pad | Other | The processing of the fat graft material is done using a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. | Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance. | Posted | Mean | Standard Deviation | units on FVAS scale | screen, 7-21 days, 3, and 9 months post-operative |
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| Secondary | Assessment of Cellular Properties of the Cells Within the Fat Graft | Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft. | Posted | Mean | Standard Deviation | percentage of ASCs within the SVF | Assessed at time of operative procedure |
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| 10 |
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| 10 |
| 10 |
| 10 |
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| Title | Measurements |
|---|---|
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| 9 months |
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