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New Treatment for Donor Sites (Donors)

This study has been withdrawn prior to enrollment.
(Donor site material (scarlet red ) came back on the market, therefore new treatements for donor sites was not needed.)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00591916
First received: December 26, 2007
Last updated: December 10, 2012
Last verified: December 2012
History of Changes

December 26, 2007
December 10, 2012
January 2006
November 2010   (final data collection date for primary outcome measure)
epidermal regeneration (donor site healing) [ Time Frame: Days 3-14 post surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00591916 on ClinicalTrials.gov Archive Site
  • Infection [ Time Frame: Days 0-21 post surgery ] [ Designated as safety issue: Yes ]
  • reduction in pain of donor site [ Time Frame: Day 0-21 post surgery ] [ Designated as safety issue: No ]
  • Scarring [ Time Frame: Day 7 post surgery to 2 years post surgery ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: Admission post burn injury to 2 years post burn injury ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
New Treatment for Donor Sites
New Treatment for Donor Sites

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn
  • Drug: 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).
  • Procedure: Blood sample
    Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
  • Procedure: Biopsy
    Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
  • Experimental: 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.
    Interventions:
    • Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]
    • Procedure: Blood sample
    • Procedure: Biopsy
  • Experimental: 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.
    Interventions:
    • Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]
    • Procedure: Blood sample
    • Procedure: Biopsy
  • Active Comparator: 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.
    Interventions:
    • Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]
    • Procedure: Blood sample
    • Procedure: Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
up to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00591916
06-388
No
The University of Texas, Galveston
The University of Texas, Galveston
Not Provided
Principal Investigator: David N Herndon, MD University of Texas
The University of Texas, Galveston
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP