Burn SurgeryNCT00974597
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
A study testing AWBAT™-D and Mepilex® Ag dressings in people with Burn Surgery, run by Aubrey Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Surgery
- What is being tested?
- AWBAT™-D and Mepilex® Ag dressings
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2010
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Burn wounds requiring skin grafting
- Matched donor sites available
- 1-30% TBSA
Who cannot join
- Severe inhalation injury
- Pregnancy
- Co-morbidity which may compromise healing
- Known allergy to pork or pork products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.
- Conditions
- Burn Surgery
- Being tested
- AWBAT™-D and Mepilex® Ag dressings
- Keywords
- burn, donor site, treatment of burns, Treatment of Donor Sites
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWBAT™-D and Mepilex® Ag dressingsDevice
Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare rate of healing of donor sites
Measured: 6 month follow-up
Secondary outcomes (3)
Compare complication rates
Measured: 6 month follow-up
Compare patient reported perception of pain
Measured: 6 month follow-up
Compare clinical outcome (scarring)
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010 (estimated)
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn SurgeryStudies 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aubrey Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974597
- Sponsor's protocol ID
- #AW-101008DS
- Status last verified
- Dec 2009
- First submitted
- 8 Sep 2009
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
- ClinicalTrials.gov ID
- NCT00974597
- Acronym / sponsor ID
- #AW-101008DS
- Conditions
- Burn Surgery
- Keywords
- burn, donor site, treatment of burns, Treatment of Donor Sites
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management Decision
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aubrey Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (estimated)
- First posted
- 10 Sep 2009 (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 study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burn wounds requiring skin grafting
- Matched donor sites available
- 1-30% TBSA
Key exclusion criteria (4 listed)
- Severe inhalation injury
- Pregnancy
- Co-morbidity which may compromise healing
- Known allergy to pork or pork 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™-D and Mepilex® Ag dressingsComparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery. | Device | – |
Primary outcome
Compare rate of healing of donor sites
Time frame: 6 month follow-up
3 secondary outcomes
Compare complication rates
Time frame: 6 month follow-up
Compare patient reported perception of pain
Time frame: 6 month follow-up
Compare clinical outcome (scarring)
Time frame: 6 month follow-up
Results and safety
The study was stopped early (reason given: Management Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWBAT™-D and Mepilex® Ag dressings in people with Burn Surgery, run by Aubrey Inc. at 1 site 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 3 inclusion and 4 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 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (reason given: Management Decision). 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?
Compare rate of healing of donor sites (time frame: 6 month follow-up). 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 22 Jun 2010.