NCT00591916

Brief Summary

Primary research questions/Purpose of the Research.

  1. 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. 2.Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

4.8 years

First QC Date

December 26, 2007

Last Update Submit

December 10, 2012

Conditions

Burn

Keywords

burndonor sitegraftingscar

Outcome Measures

Primary Outcomes (1)

  • epidermal regeneration (donor site healing)

    Days 3-14 post surgery

Secondary Outcomes (4)

  • 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

Study Arms (3)

1

EXPERIMENTAL

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)]Procedure: Blood sampleProcedure: Biopsy

2

EXPERIMENTAL

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)]Procedure: Blood sampleProcedure: Biopsy

3

ACTIVE COMPARATOR

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)]Procedure: Blood sampleProcedure: Biopsy

Interventions

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

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

123
Blood samplePROCEDURE

Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery

123
BiopsyPROCEDURE

Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.

123

Eligibility Criteria

Age1 Day - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 0-90 years.
  • Any patient admitted to the hospital with burn injury requiring grafting and a donor site.

You may not qualify if:

  • Patient with severe burn injuries expected to die.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BurnsCicatrix

Interventions

Scarlet RedHyaluronic AcidThrombinBlood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

Wounds and InjuriesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological FactorsSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • David N Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

January 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 11, 2012

Record last verified: 2012-12