Study Stopped
PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.
The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMarch 19, 2021
March 1, 2021
2 years
November 11, 2019
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (4)
One donor
EXPERIMENTALParticipants will receive skin allograft from 1 distinct cadavers.
Two donors
EXPERIMENTALParticipants will receive skin allograft from 2 distinct cadavers.
Three donors
EXPERIMENTALParticipants will receive skin allograft from 3 distinct cadavers.
Control
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- AlloSourcecollaborator
Related 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.
PMID: 25683513BACKGROUNDKlein 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.
PMID: 29929900BACKGROUNDKlein 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.
PMID: 26392022BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Feldman
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2019
First Posted
November 14, 2019
Study Start
February 1, 2021
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share