The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients
NCT ID: NCT04162639
Last Updated: 2021-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-02-28
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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One donor
Participants will receive skin allograft from 1 distinct cadavers.
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.
Two donors
Participants will receive skin allograft from 2 distinct cadavers.
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.
Three donors
Participants will receive skin allograft from 3 distinct cadavers.
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.
Control
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AlloSource
INDUSTRY
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Michael Feldman
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
References
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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.
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.
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.
Other Identifiers
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HM20015249
Identifier Type: -
Identifier Source: org_study_id
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