Treatment of Donor Site BurnsAWBAT-DNCT00964470
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
A study testing AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings in people with Treatment of Donor Site Burns, run by Aubrey Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Donor Site Burns
- What is being tested?
- AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Dec 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 measuring 1% - 30% TBSA requiring skin grafting
- Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen
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, 3 recruiting
- Recruiting
The University Hospital Burn Center Cincinnati
Cincinnati, Ohio, 45219
J. Kevin Bailey, MD, 513-558-4361, baileyj4@ucmail.uc.edu
Rich Branson, MD, 513-558-6785, richard.branson@uc.edu
- Recruiting
Wishard Health Services Burn Center
Indianapolis, Indiana, 46204
Rajiv Sood, MD, 317-278-1022, rsood@iupui.edu
Rajiv Sood, MD
- Recruiting
Firefighter's Regional Burn Center
Memphis, Tennessee, 38103
William Hickerson, MD, 901-448-2579, bhickerson@mac.com
Lisa K Mason-Sutton, BSN, 901-448-2525, lmasonsu@utmem.edu
About this study
The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.
Read the detailed description
The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery.
Primary Study Goals:
- To compare the rate of healing of donor sites.
- To compare patient reported perception of pain
- To compare the potential clinical complication rates of:
- non-adherence,
- seroma
- hematoma
- infection
Secondary Study Goal:
- To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.
- Conditions
- Treatment of Donor Site Burns
- Being tested
- AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
- Keywords
- Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™
- 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 XEROFORM™ OR GLUCAN II™ dressingsDevice
Also called AWBAT™-D and XEROFORM™ OR GLUCAN II™ donor site dressings
Dressing, donor site dressings
What is being measured
The primary outcome is the main question the study is designed to answer.
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection
Measured: 2 year follow-up
Secondary outcomes (1)
• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Donor Site 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aubrey Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964470
- Sponsor's protocol ID
- #AW-101008MC-DS
- Acronym
- AWBAT-D
- Status last verified
- Sep 2009
- First submitted
- 23 Aug 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
- Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
- ClinicalTrials.gov ID
- NCT00964470
- Acronym / sponsor ID
- AWBAT-D / #AW-101008MC-DS
- Conditions
- Treatment of Donor Site Burns
- Keywords
- Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aubrey Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 25 Aug 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 compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.
Detailed description
The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery.
Primary Study Goals:
- To compare the rate of healing of donor sites.
- To compare patient reported perception of pain
- To compare the potential clinical complication rates of:
- non-adherence,
- seroma
- hematoma
- infection
Secondary Study Goal:
- To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.
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 (2 listed)
- Burn wounds measuring 1% - 30% TBSA requiring skin grafting
- Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen
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™-D and XEROFORM™ OR GLUCAN II™ dressingsAlso: AWBAT™-D and XEROFORM™ OR GLUCAN II™ donor site dressingsDressing, donor site dressings | Device | – |
Primary outcome
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection
Time frame: 2 year follow-up
1 secondary outcome
• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.
Time frame: 2 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
Related trials for Treatment of Donor Site Burns
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Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
Recruiting
Blue Light for Donor Site Healing in Burn Patients
Donor Site Complication, Burn
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.
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™-D and XEROFORM™ OR GLUCAN II™ dressings in people with Treatment of Donor Site 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 2 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: status not confirmed, 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Moss (760-602-8300, smoss@aubreyinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection (time frame: 2 year 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.