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Use of Pressure Garments for Burn Scars (Jobst)

Primary Purpose

Burns

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Jobst Pressure Garment
Medical Z pressure garment
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 Burns focused on measuring Burn, Scar, Pressure garments, Wound healing, Burn Injury

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
  • at least 1 year of age and no more than 17 years of age
  • Wound closure
  • No evidence of deep venous thrombosis or other vascular compromise.
  • No concomitant conflicting study protocols.

Exclusion Criteria:

  • Burn injuries not bilateral to upper and/or lower extremities.
  • Evidence of vascular compromise.
  • Conflicting protocols.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    Pressure garment therapy

    No pressure garment therapy

    Outcomes

    Primary Outcome Measures

    Differences in scarring between pressure garment therapy and no pressure garment therapy

    Secondary Outcome Measures

    Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.
    Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy

    Full Information

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

    Unique Protocol Identification Number
    NCT00675974
    Brief Title
    Use of Pressure Garments for Burn Scars
    Acronym
    Jobst
    Official Title
    Prospective Randomized Study of the Effectiveness of Prospective Randomized Study on the Effectiveness of Pressure Garment Therapy for the Prevention of Hypertrophic Scarring in Burned Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston
    Collaborators
    U.S. Department of Education

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy. How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity. Will Pressure Garment Therapy diminish discomfort due to pruritus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns
    Keywords
    Burn, Scar, Pressure garments, Wound healing, Burn Injury

    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
    Pressure garment therapy
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    No pressure garment therapy
    Intervention Type
    Device
    Intervention Name(s)
    Jobst Pressure Garment
    Other Intervention Name(s)
    Jobst pressure garments, Medical Z pressure garments, Pressure garments
    Intervention Description
    Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.
    Intervention Type
    Device
    Intervention Name(s)
    Medical Z pressure garment
    Other Intervention Name(s)
    Pressure garment, Jobst pressure garment
    Intervention Description
    Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.
    Primary Outcome Measure Information:
    Title
    Differences in scarring between pressure garment therapy and no pressure garment therapy
    Time Frame
    Time of burn to 2 years post burn
    Secondary Outcome Measure Information:
    Title
    Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.
    Time Frame
    Time of burn to 2 years post burn
    Title
    Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy
    Time Frame
    Time of burn to 2 years post burn

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities. at least 1 year of age and no more than 17 years of age Wound closure No evidence of deep venous thrombosis or other vascular compromise. No concomitant conflicting study protocols. Exclusion Criteria: Burn injuries not bilateral to upper and/or lower extremities. Evidence of vascular compromise. Conflicting protocols.
    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 Pressure Garments for Burn Scars

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