Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery (AWBAT-D)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Aubrey Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Aubrey Inc.
Information provided by:
Aubrey Inc.
ClinicalTrials.gov Identifier:
NCT00964470
First received: August 23, 2009
Last updated: June 21, 2010
Last verified: September 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 23, 2009 | ||||||||
| Last Updated Date | June 21, 2010 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
• 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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00964470 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale. [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery | ||||||||
| Official Title ICMJE | Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery | ||||||||
| Brief 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. |
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| 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:
Secondary Study Goal: • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Treatment of Donor Site Burns | ||||||||
| Intervention ICMJE | Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
Dressing, donor site dressings
Other Name: AWBAT™-D and XEROFORM™ OR GLUCAN II™ donor site dressings |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00964470 | ||||||||
| Other Study ID Numbers ICMJE | #AW-101008MC-DS | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Stephen Moss/President, Aubrey Inc. | ||||||||
| Study Sponsor ICMJE | Aubrey Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Aubrey Inc. | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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