BurnsNCT01067729
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
A study testing AWBAT Wound Dressing and AWBAT™, Biobrane® in people with Burns, run by Aubrey Inc. at 3 sites in United States.
Trial summary
The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings. Read more about this study
- Who is it for?
- Ages 1 year to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- AWBAT Wound Dressing and AWBAT™, Biobrane®
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Nov 2009to Jun 2011
- Phase
- Interventional
- 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 year to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Superficial partial thickness burns
- Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
- One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
- Burn wounds measuring >2% - <40% TBSA
- Patient age: >1 - 70 years
Who cannot join
- Ventilator dependence
- Pregnancy/Lactation
- Mechanism of injury was electrical, chemical or frostbite
- Co-morbidity which may compromise healing
- Known allergy to porcine or porcine products
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Missouri Health Care
Columbia, Missouri, 65212
Shriners Hospitals for Children
Galveston, Texas, 77550
UC Irvine Burn Center
Irvine, California, 92868
About this study
Official title: A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®
The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.
Read the detailed description
The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.
- Conditions
- Burns
- Being tested
- AWBAT Wound Dressing, AWBAT™, Biobrane®
- Keywords
- Burn, Superficial burns, Partial thickness burns, Rate of healing, Infection rate, Pain perception, Non adherence, Scarring
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWBAT Wound DressingDevice
Also called Biobrane
AWBAT™, Biobrane®Device
Comparison of burn dressings on randomized body sites using patient as own control
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healing
Measured: Day 14
Secondary outcomes (1)
Scarring
Measured: 6 months, 1 year, 18 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Aubrey Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067729
- Sponsor's protocol ID
- #AW-101508MC
- Status last verified
- Feb 2010
- First submitted
- 10 Feb 2010
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®
- ClinicalTrials.gov ID
- NCT01067729
- Acronym / sponsor ID
- #AW-101508MC
- Conditions
- Burns
- Keywords
- Burn, Superficial burns, Partial thickness burns, Rate of healing, Infection rate, Pain perception, Non adherence, Scarring
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Aubrey Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- First posted
- 12 Feb 2010 (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.
The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.
Detailed description
The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Superficial partial thickness burns
- Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
- One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
- Burn wounds measuring >2% - <40% TBSA
- Patient age: >1 - 70 years
Key exclusion criteria (5 listed)
- Ventilator dependence
- Pregnancy/Lactation
- Mechanism of injury was electrical, chemical or frostbite
- Co-morbidity which may compromise healing
- Known allergy to porcine or porcine products
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 |
|---|---|---|
| AWBAT Wound DressingAlso: Biobrane | Device | – |
| AWBAT™, Biobrane®Comparison of burn dressings on randomized body sites using patient as own control | Device | – |
Primary outcome
Rate of healing
Time frame: Day 14
1 secondary outcome
Scarring
Time frame: 6 months, 1 year, 18 months and 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWBAT Wound Dressing and AWBAT™, Biobrane® in people with Burns, run by Aubrey Inc. at 3 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 5 inclusion and 5 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was stopped early. Results are not available in the source record.
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?
Rate of healing (time frame: Day 14). 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 26 Jan 2015.