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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this research study is to find out if it is safe and feasible to improve the appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken from other parts of your body and injected, or transplanted into a scar. This procedure is called autologous fat transfer (AFT). The main goal of this study is to see if AFT is safe and can improve the quality and appearance of scar tissue. Another main goal is to determine how much tissue should be transplanted to get the best results.
Before you begin study treatment, you will have the following tests and procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo procedure |
|
| Autologous Fat Transfer (AFT) group | Experimental | Subjects will be registered in the context of either the Early AFT subgroup, or the Delayed AFT subgroup based on the timing of their wound closure: early AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 2-4 weeks of definitive closure (STSG) or healing (secondary closure) and the delayed AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 6 months or more of definitive closure (STSG) or healing (secondary closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Fat Transfer | Procedure | one site will be treated with AFT For placebo treated (control) sites, an equal number of empty cannula passes will be administered using a similar technique described for the AFT. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and feasibility of using AFT in early and delayed treatment settings to positively enhance the quality and appearance of overlying scar and to determine the safety and impact of AFT "dose" on scar quality and appearance. | If no Dose Limiting Toxicity (DLT) is observed ,dose escalation will occur. Study sites/scars will be delineated by tracings, digital photography,scar assessment scale,and measures of scar elasticity and color. To correlate efficacy with graft quality, a sample of each adipose harvest will be sent to the laboratory for quantitative analysis of the stromal vascular fraction (SVF) with the adipose sample. | 4 times for a year |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the correlation of subjective and objective scar assessment tools for serial, prospective scar analysis. | 4 times for a year |
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Inclusion Criteria:
At least 2 separate (i.e. non-contiguous) wounds/scars previously healed by placement of a STSG and/or by secondary intention ("study sites"), each ≤ 50cm2 in size (area).
o The study sites should be similar in size and anatomical location (e.g. upper arms; trunk; legs) to the extent practically possible
Adequate adipose depot for tissue harvest
For Early AFT Subgroup:
o medically stable such that study sites are amenable to AFT within 2-4 weeks after definitive closure(STSG) or healing (secondary closure)
For Delayed AFT Subgroup:
o medically stable such that study sites are amenable to AFT at least 6 months after definitive closure(STSG) or healing (secondary closure)
Age range: 18-65 years
Negative pregnancy test
Able and willing to provide verbal and written informed consent.
Subject should begin protocol initiation within 2 weeks of being enrolled.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Katz, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Institute of Surgical Research (ISR)/Brooke Army Medical Center (BAMC) |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Fort Sam Houston |
| Texas |
| 78234 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |