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

Primary Purpose

Burns

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Skin allograft
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    One donor

    Two donors

    Three donors

    Control

    Arm Description

    Participants will receive skin allograft from 1 distinct cadavers.

    Participants will receive skin allograft from 2 distinct cadavers.

    Participants will receive skin allograft from 3 distinct cadavers.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2019
    Last Updated
    March 16, 2021
    Sponsor
    Virginia Commonwealth University
    Collaborators
    AlloSource
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04162639
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University
    Collaborators
    AlloSource

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    One donor
    Arm Type
    Experimental
    Arm Description
    Participants will receive skin allograft from 1 distinct cadavers.
    Arm Title
    Two donors
    Arm Type
    Experimental
    Arm Description
    Participants will receive skin allograft from 2 distinct cadavers.
    Arm Title
    Three donors
    Arm Type
    Experimental
    Arm Description
    Participants will receive skin allograft from 3 distinct cadavers.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Skin allograft
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in participant's panel reactive antibody (PRA) score at 1 month
    Description
    Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample.
    Time Frame
    Baseline to 1 month
    Title
    Change in participant's panel reactive antibody (PRA) score at 6 months
    Description
    Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample.
    Time Frame
    Baseline to 6 months
    Title
    Change in participant's panel reactive antibody (PRA) score at 12 month
    Description
    Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample.
    Time Frame
    Baseline to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Feldman
    Organizational Affiliation
    Virginia Commonwealth University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25683513
    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.
    Results Reference
    background
    PubMed Identifier
    29929900
    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.
    Results Reference
    background
    PubMed Identifier
    26392022
    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.
    Results Reference
    background

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

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