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Donor site material (scarlet red ) came back on the market, therefore new treatements for donor sites was not needed.
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Primary research questions/Purpose of the Research.
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
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| 2 | Experimental | 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. |
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| 3 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)] | Drug | Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT). |
| Measure | Description | Time Frame |
|---|---|---|
| epidermal regeneration (donor site healing) | Days 3-14 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Days 0-21 post surgery | |
| reduction in pain of donor site | Day 0-21 post surgery | |
| Scarring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Herndon, MD | University of Texas | Principal Investigator |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C009213 | Scarlet Red |
| D006820 | Hyaluronic Acid |
| D013917 | Thrombin |
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D012697 | Serine Endopeptidases |
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| Blood sample | Procedure | Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery |
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| Biopsy | Procedure | Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn. |
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| Day 7 post surgery to 2 years post surgery |
| Costs | Admission post burn injury to 2 years post burn injury |
| D010450 |
| Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |