The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients

Conditions
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Burns

Intervention / Treatment
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* Biological: Skin allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 years or older Burns of deep partial thickness or full thickness depth totaling less than or equal to 10% total body surface area. Injury requiring staged reconstruction with allograft skin (experimental group) Injury requiring reconstruction with autograft skin (i.e. no cadaver skin; control group) Exclusion Criteria: Burns exceeding 10% total body surface area. Pre-existing allosensitization at time of injury Blood or blood product transfusion requirement Pregnancy at the time of injury or during study period History of solid organ transplant during study period History of autoimmune disorder (systemic lupus erythematosus, etc.) History of mechanical circulatory support (extracorporeal membrane oxygenation, ventricular assist device, total artificial heart) during study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One donor<br>Participants will receive skin allograft from 1 distinct cadavers. | Biological: Skin allograft<br>* 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.<br>|
| Experimental: Two donors<br>Participants will receive skin allograft from 2 distinct cadavers. | Biological: Skin allograft<br>* 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.<br>|
| Experimental: Three donors<br>Participants will receive skin allograft from 3 distinct cadavers. | Biological: Skin allograft<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |