BurnPhase 2/3DonorsNCT00591916
New Treatment for Donor Sites
A Phase 2/3 study testing Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Blood sample and Biopsy in people with Burn, run by The University of Texas Medical Branch, Galveston.
Trial summary
Primary research questions/Purpose of the Research. 1. Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and… Read more about this study
- Who is it for?
- Ages 1 day to 90 years
- Conditions the study is for
- Burn
- What is being tested?
- Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Blood sample and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Nov 2010
- Phase
- Phase 2/3
- 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 1 day to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 0-90 years.
- Any patient admitted to the hospital with burn injury requiring grafting and a donor site.
Who cannot join
- Patient with severe burn injuries expected to die.
About this study
Primary research questions/Purpose of the Research.
- Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).
- Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.
- Describe the importance of the knowledge that you expect to gain from the research. To find a donor site dressing that has outcomes equal or better than that of scarlet red.
- Conditions
- Burn
- Being tested
- Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Blood sample, Biopsy
- Keywords
- burn, donor site, grafting, scar
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]Drug
Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).
Blood sampleProcedure or surgery
Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
BiopsyProcedure or surgery
Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Microbial Nanocellulose (NC), an inert material produced by Acetobacter xylinum is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery. Receives: Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]; Procedure: Blood sample; Procedure: Biopsy |
| 2 | Experimental | fine mesh gauze impregnated with hyaluronan and thrombin (HT) is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery. Receives: Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]; Procedure: Blood sample; Procedure: Biopsy |
| 3 | Active comparator | Scarlet Red is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery. Receives: Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]; Procedure: Blood sample; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidermal regeneration (donor site healing)
Measured: Days 3-14 post surgery
Secondary outcomes (4)
Infection
Measured: Days 0-21 post surgery
reduction in pain of donor site
Measured: Day 0-21 post surgery
Scarring
Measured: Day 7 post surgery to 2 years post surgery
Costs
Measured: Admission post burn injury to 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 posted11 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Donor site material (scarlet red ) came back on the market, therefore new treatements for donor sites was not needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00591916
- Sponsor's protocol ID
- 06-388
- Acronym
- Donors
- Status last verified
- Dec 2012
- First submitted
- 26 Dec 2007
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Treatment for Donor Sites
- ClinicalTrials.gov ID
- NCT00591916
- Acronym / sponsor ID
- Donors / 06-388
- Conditions
- Burn
- Keywords
- burn, donor site, grafting, scar
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Donor site material (scarlet red ) came back on the market, therefore new treatements for donor sites was not needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Jan 2008 (estimated)
- 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.
Primary research questions/Purpose of the Research.
- Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).
- Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.
- Describe the importance of the knowledge that you expect to gain from the research. To find a donor site dressing that has outcomes equal or better than that of scarlet red.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Procedure: Blood sample, Procedure: BiopsyMicrobial Nanocellulose (NC), an inert material produced by Acetobacter xylinum is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery. |
| 2 | Experimental | Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Procedure: Blood sample, Procedure: Biopsyfine mesh gauze impregnated with hyaluronan and thrombin (HT) is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery. |
| 3 | Active comparator | Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Procedure: Blood sample, Procedure: BiopsyScarlet Red is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery. |
Who may qualify
- Ages
- 1 day to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 0-90 years.
- Any patient admitted to the hospital with burn injury requiring grafting and a donor site.
Key exclusion criteria (1 listed)
- Patient with severe burn injuries expected to die.
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 |
|---|---|---|
| Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT). | Drug | 1, 2, 3 |
| Blood sampleObtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery | Procedure or surgery | 1, 2, 3 |
| BiopsyTissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn. | Procedure or surgery | 1, 2, 3 |
Primary outcome
epidermal regeneration (donor site healing)
Time frame: Days 3-14 post surgery
4 secondary outcomes
Infection
Time frame: Days 0-21 post surgery
reduction in pain of donor site
Time frame: Day 0-21 post surgery
Scarring
Time frame: Day 7 post surgery to 2 years post surgery
Costs
Time frame: Admission post burn injury to 2 years post burn injury
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 11 Dec 2012.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)], Blood sample and Biopsy in people with Burn, run by The University of Texas Medical Branch, Galveston.
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: withdrawn, as of the sponsor's last update on 11 Dec 2012. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
epidermal regeneration (donor site healing) (time frame: Days 3-14 post surgery). 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 11 Dec 2012.