New Treatment for Donor Sites (Donors)

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Burn

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00591916

06-388

Details and patient eligibility

About

Primary research questions/Purpose of the Research.

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.

Sex: All

Ages: 1 day to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

1

Experimental group

Description:

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.

Treatment:

Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]

Procedure: Biopsy

Procedure: Blood sample

2

Experimental group

Description:

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.

Treatment:

Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]

Procedure: Biopsy

Procedure: Blood sample

3

Active Comparator group

Description:

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.

Treatment:

Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]

Procedure: Biopsy

Procedure: Blood sample