Clinical trial NCT04162639: The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients
Official title: The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Burns
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: AlloSource
First posted: 2019-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in participant's panel reactive antibody (PRA) score at 1 month
timeFrame: Baseline to 1 month
measure: Change in participant's panel reactive antibody (PRA) score at 6 months
timeFrame: Baseline to 6 months
measure: Change in participant's panel reactive antibody (PRA) score at 12 month
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Michael Feldman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Klein HJ, Lehner F, Schweizer R, Rusi-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.
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.