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

Virginia Commonwealth University (VCU)

Status and phase: Withdrawn; Phase 4

Conditions: Burns

Treatments: Biological: Skin allograft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04162639

HM20015249

Details and patient eligibility

About

The purpose of this research study is to look at how the body's immune system reacts to temporary skin grafts from deceased donors.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

One donor

Experimental group

Description:

Participants will receive skin allograft from 1 distinct cadavers.

Treatment:

Biological: Skin allograft

Two donors

Experimental group

Description:

Participants will receive skin allograft from 2 distinct cadavers.

Treatment:

Biological: Skin allograft

Three donors

Experimental group

Description:

Participants will receive skin allograft from 3 distinct cadavers.

Treatment:

Biological: Skin allograft

Control

No Intervention group

Description:

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.