BurnsQuadNCT00676013
Comparison of Skin Substitutes Used in Burn Care
A study testing Integra, AlloDerm and Homograft in people with Burns, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts: 1. will reduce scar formation of skin grafts 2. will reduce burn wound contractures 3. will improve functional outcome of joints requiring grafts Compare scarring outcome of Dermal products Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Burns
- What is being tested?
- Integra, AlloDerm and Homograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 1997to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn injury requiring grafting
- 0 years-90 years
Who cannot join
- Partial thickness burns only
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:
- will reduce scar formation of skin grafts
- will reduce burn wound contractures
- will improve functional outcome of joints requiring grafts
Compare scarring outcome of Dermal products
Read the detailed description
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.
- Conditions
- Burns
- Being tested
- Integra, AlloDerm, Homograft, Autograft
- Keywords
- Burns, Skin grafting, AlloDerm, Integra, Homograft, Autograft, Burn Scar
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntegraProcedure or surgery
Also called Artificial dermis
Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.
AlloDermProcedure or surgery
Also called Cadaver skin
Grafting using the commercial product AlloDerm as a skin substitute
HomograftProcedure or surgery
Also called Cadaver Skin
Grafting using homograft as a skin substitute
AutograftProcedure or surgery
grafting using patients own skin from a separate donor site
| Study group | Role | What they receive |
|---|---|---|
| Alloderm, Integra, Homograft, Autograft | Experimental | Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient Receives: Procedure: Integra; Procedure: AlloDerm; Procedure: Homograft; Procedure: Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burn Scar Comparison
Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.
Measured: 2 years post burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startDec 1997
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Unable to continue study following Hurricane Ike.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676013
- Sponsor's protocol ID
- 97-286
- Acronym
- Quad
- Status last verified
- Aug 2018
- First submitted
- 26 Dec 2007
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction
- ClinicalTrials.gov ID
- NCT00676013
- Acronym / sponsor ID
- Quad / 97-286
- Conditions
- Burns
- Keywords
- Burns, Skin grafting, AlloDerm, Integra, Homograft, Autograft, Burn Scar
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue study following Hurricane Ike.
- Enrolment
- 158 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Dec 1997
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 16 Dec 2019
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 study is to determine if using a DERMAL LAYER under skin grafts:
- will reduce scar formation of skin grafts
- will reduce burn wound contractures
- will improve functional outcome of joints requiring grafts
Compare scarring outcome of Dermal products
Detailed description
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alloderm, Integra, Homograft, Autograft | Experimental | Procedure: Integra, Procedure: AlloDerm, Procedure: Homograft, Procedure: AutograftBurn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Burn injury requiring grafting
- 0 years-90 years
Key exclusion criteria (1 listed)
- Partial thickness burns only
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 |
|---|---|---|
| IntegraAlso: Artificial dermisGrafting using the Commercial product Integra as a skin substitute over full thickness burn following excision. | Procedure or surgery | Alloderm, Integra, Homograft, Autograft |
| AlloDermAlso: Cadaver skinGrafting using the commercial product AlloDerm as a skin substitute | Procedure or surgery | Alloderm, Integra, Homograft, Autograft |
| HomograftAlso: Cadaver SkinGrafting using homograft as a skin substitute | Procedure or surgery | Alloderm, Integra, Homograft, Autograft |
| Autograftgrafting using patients own skin from a separate donor site | Procedure or surgery | Alloderm, Integra, Homograft, Autograft |
Primary outcome
Burn Scar Comparison
Time frame: 2 years post burn injury
Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David N Herndon, MD principal investigator
University of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integra, AlloDerm and Homograft in people with Burns, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Burn Scar Comparison (time frame: 2 years post burn injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2019.