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PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.
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| Name | Class |
|---|---|
| AlloSource | INDUSTRY |
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The purpose of this research study is to look at how the body's immune system reacts to temporary skin grafts from deceased donors.
Some burns will heal best with the use of temporary skin grafts from cadavers before covering the burns with grafts of the patient's own skin. This is the usual care for these types of burn injuries recommended by burn surgeons. This skin is applied in the operating room and removed after several days. During that time, the body's immune system will make antibodies to the skin. Normally, these antibodies are harmless. However, extra antibodies can make it difficult to find donors for transplants. The results of this study will be used to better understand how to treat a subset of burn patients with very severe burns in a way that allows them to receive tissue transplants (e.g. face transplants, hand transplants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One donor | Experimental | Participants will receive skin allograft from 1 distinct cadavers. |
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| Two donors | Experimental | Participants will receive skin allograft from 2 distinct cadavers. |
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| Three donors | Experimental | Participants will receive skin allograft from 3 distinct cadavers. |
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| Control | No Intervention | Participants will be burned patients with wounds that do not require skin allografts, but are instead reconstructed with their own skin (skin autografts) in a single stage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin allograft | Biological | Participants will receive skin allograft from either 1, 2 or 3 distinct cadavers. This skin allograft will be applied in a routine fashion, with no deviation from the typical clinical course of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant's panel reactive antibody (PRA) score at 1 month | Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample. | Baseline to 1 month |
| Change in participant's panel reactive antibody (PRA) score at 6 months | Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample. | Baseline to 6 months |
| Change in participant's panel reactive antibody (PRA) score at 12 month | Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Feldman | Virginia Commonwealth University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25683513 | Background | Duhamel P, Suberbielle C, Grimbert P, Leclerc T, Jacquelinet C, Audry B, Bargues L, Charron D, Bey E, Lantieri L, Hivelin M. Anti-HLA sensitization in extensively burned patients: extent, associated factors, and reduction in potential access to vascularized composite allotransplantation. Transpl Int. 2015 May;28(5):582-93. doi: 10.1111/tri.12540. Epub 2015 Feb 26. | |
| 29929900 |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Klein HJ, Lehner F, Schweizer R, Rusi-Elsener B, Nilsson J, Plock JA. Screening of HLA sensitization during acute burn care. Burns. 2018 Aug;44(5):1330-1335. doi: 10.1016/j.burns.2018.01.010. Epub 2018 Mar 7. |
| 26392022 | Background | Klein HJ, Schanz U, Hivelin M, Waldner M, Koljonen V, Guggenheim M, Giovanoli P, Gorantla VS, Fehr T, Plock JA. Sensitization and desensitization of burn patients as potential candidates for vascularized composite allotransplantation. Burns. 2016 Mar;42(2):246-57. doi: 10.1016/j.burns.2015.05.019. Epub 2015 Sep 29. |