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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04162639
• Other study ID #: HM20015249
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2021
• Est. completion date: February 2023

Study information

• Verified date: March 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	AlloSource

References & Publications (3)

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. — View Citation

Klein HJ, Lehner F, Schweizer R, Rüsi-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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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