New Treatment for Donor Sites (Donors)

December 10, 2012 updated by: The University of Texas Medical Branch, Galveston

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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