Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2006-01-31
2010-11-30
Brief Summary
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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 thrombin (HT).
2. Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.
b. 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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.
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).
Blood sample
Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
Biopsy
Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
2
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.
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).
Blood sample
Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
Biopsy
Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
3
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.
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).
Blood sample
Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
Biopsy
Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
Interventions
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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).
Blood sample
Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
Biopsy
Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
Eligibility Criteria
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Inclusion Criteria
* Any patient admitted to the hospital with burn injury requiring grafting and a donor site.
Exclusion Criteria
1 Day
90 Years
ALL
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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David N Herndon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Countries
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Other Identifiers
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06-388
Identifier Type: -
Identifier Source: org_study_id