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

Phase 4

Withdrawn

• Conditions: Burns
• Interventions: Biological: Skin allograft

• Registration Number: NCT04162639
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Study Start: 2021-02
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-19
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One donor	Skin allograft	Participants will receive skin allograft from 1 distinct cadavers.
Three donors	Skin allograft	Participants will receive skin allograft from 3 distinct cadavers.
Two donors	Skin allograft	Participants will receive skin allograft from 2 distinct cadavers.

Primary Outcome Measures

Name	Time	Method
Change in participant's panel reactive antibody (PRA) score at 6 months	Baseline to 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.
Change in participant's panel reactive antibody (PRA) score at 12 month	Baseline to 12 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.
Change in participant's panel reactive antibody (PRA) score at 1 month	Baseline to 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.