New Treatment for Donor Sites

Phase 2

Withdrawn

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

• Registration Number: NCT00591916
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]	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.
1	Blood sample	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.
1	Biopsy	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.
3	Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]	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.
3	Blood sample	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.
3	Biopsy	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.
2	Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]	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.
2	Blood sample	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.
2	Biopsy	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.

Primary Outcome Measures

Name	Time	Method
epidermal regeneration (donor site healing)	Days 3-14 post surgery

Secondary Outcome Measures

Name	Time	Method
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