New Treatment for Donor Sites

Study Overview
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Brief Summary
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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.

Official Title
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New Treatment for Donor Sites

Conditions
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Burn

Intervention / Treatment
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* Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]
* Procedure: Blood sample
* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 0-90 years. Any patient admitted to the hospital with burn injury requiring grafting and a donor site. Exclusion Criteria: Patient with severe burn injuries expected to die.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]<br>* Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).<br>Procedure: Blood sample<br>* Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery<br>Procedure: Biopsy<br>* Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.<br>|
| Experimental: 2<br>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. | Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]<br>* Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).<br>Procedure: Blood sample<br>* Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery<br>Procedure: Biopsy<br>* Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.<br>|
| Active Comparator: 3<br>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. | Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]<br>* Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).<br>Procedure: Blood sample<br>* Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery<br>Procedure: Biopsy<br>* Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidermal regeneration (donor site healing) |  | Days 3-14 post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection |  | Days 0-21 post surgery | 
| reduction in pain of donor site |  | Day 0-21 post surgery | 
| Scarring |  | Day 7 post surgery to 2 years post surgery | 
| Costs |  | Admission post burn injury to 2 years post burn injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn, donor site, grafting, scar