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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Burn
Drug: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]
Procedure: Blood sample
Procedure: Biopsy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Treatment for Donor Sites

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • epidermal regeneration (donor site healing) [ Time Frame: Days 3-14 post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591916

Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00591916     History of Changes
Other Study ID Numbers: 06-388
Study First Received: December 26, 2007
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
burn
donor site
grafting
scar

Additional relevant MeSH terms:
Thrombin
Hyaluronic Acid
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014