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Use of Amnion on Partial Thickness Burns (Amnion)

Primary Purpose

Burn

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Amnion
Amnion
Polysporin/Bacitracin/Mycostatin
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn focused on measuring Burn, Partial thickness burn

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Partial thickness burn injury.
  • >2% burn injury.
  • Ages 0-100 years.

Exclusion Criteria:

  • Patients not expected to survive

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)

    Amnion with processing procedures involving the use of Dispase II

    Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin

    Outcomes

    Primary Outcome Measures

    Length of time to 95% healing of treated burn wounds

    Secondary Outcome Measures

    Length of hospital stay
    Incidence of infection
    Amount of daily pain until wound is healed with different treatments.
    Amount of scaring with different treatments

    Full Information

    First Posted
    December 26, 2007
    Last Updated
    November 13, 2012
    Sponsor
    The University of Texas Medical Branch, Galveston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00674999
    Brief Title
    Use of Amnion on Partial Thickness Burns
    Acronym
    Amnion
    Official Title
    Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Hurricane- terminated study due to skin bank being destroyed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    September 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burn
    Keywords
    Burn, Partial thickness burn

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Amnion with processing procedures involving the use of Dispase II
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin
    Intervention Type
    Biological
    Intervention Name(s)
    Amnion
    Intervention Description
    Application of Amnion with processing procedures involving the use of trypsin-EDTA
    Intervention Type
    Biological
    Intervention Name(s)
    Amnion
    Intervention Description
    Application of Amnion with processing procedures involving the use of Dispase II
    Intervention Type
    Drug
    Intervention Name(s)
    Polysporin/Bacitracin/Mycostatin
    Intervention Description
    Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined
    Primary Outcome Measure Information:
    Title
    Length of time to 95% healing of treated burn wounds
    Time Frame
    Assessment daily until 95 % healed
    Secondary Outcome Measure Information:
    Title
    Length of hospital stay
    Time Frame
    Measured at hospital discharge
    Title
    Incidence of infection
    Time Frame
    Measure daily until complete wound healing
    Title
    Amount of daily pain until wound is healed with different treatments.
    Time Frame
    Daily until wound is completely healed.
    Title
    Amount of scaring with different treatments
    Time Frame
    From injury to 2 years post burn

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Partial thickness burn injury. >2% burn injury. Ages 0-100 years. Exclusion Criteria: Patients not expected to survive
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David N Herndon, MD
    Organizational Affiliation
    University of Texas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Use of Amnion on Partial Thickness Burns

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