BurnsPhase 4NCT04162639
The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients
A Phase 4 study testing Skin allograft in people with Burns, run by Virginia Commonwealth University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Skin allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients
The purpose of this research study is to look at how the body's immune system reacts to temporary skin grafts from deceased donors.
Read the 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).
- Conditions
- Burns
- Being tested
- Skin allograft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin allograftBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| One donor | Experimental | Participants will receive skin allograft from 1 distinct cadavers. Receives: Biological: Skin allograft |
| Two donors | Experimental | Participants will receive skin allograft from 2 distinct cadavers. Receives: Biological: Skin allograft |
| Three donors | Experimental | Participants will receive skin allograft from 3 distinct cadavers. Receives: Biological: Skin allograft |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study startFeb 2021 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- AlloSource
- Responsible party
- Sponsor
- Investigators
- Michael Feldman, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162639
- Sponsor's protocol ID
- HM20015249
- Status last verified
- Mar 2021
- First submitted
- 11 Nov 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25683513Klein 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.
PubMed 29929900Klein 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.
PubMed 26392022
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients
- ClinicalTrials.gov ID
- NCT04162639
- Acronym / sponsor ID
- HM20015249
- Conditions
- Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- AlloSource
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One donor | Experimental | Biological: Skin allograftParticipants will receive skin allograft from 1 distinct cadavers. |
| Two donors | Experimental | Biological: Skin allograftParticipants will receive skin allograft from 2 distinct cadavers. |
| Three donors | Experimental | Biological: Skin allograftParticipants will receive skin allograft from 3 distinct cadavers. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin allograftParticipants 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. | Biological | One donor, Three donors, Two donors |
Primary outcome
Change in participant's panel reactive antibody (PRA) score at 1 month
Time frame: Baseline to 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
Time frame: Baseline to 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
Time frame: Baseline to 12 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 25683513Duhamel 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.
- Background: PubMed 29929900Klein 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.
- Background: PubMed 26392022Klein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Feldman principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin allograft in people with Burns, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's panel reactive antibody (PRA) score at 1 month (time frame: Baseline to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162639, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.