NCT04162639

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Burns

Interventions

Type	Name	Description
BIOLOGICAL	Skin allograft	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2019-11-14
• Last updated: 2021-03-19

Regulatory

• FDA-regulated drug study