Use of Pressure Garments for Burn Scars (Jobst)

November 13, 2012 updated by: The University of Texas Medical Branch, Galveston

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

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

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Withdrawn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

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
Pressure garment therapy
Device: Jobst Pressure Garment
Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.
Other Names:
  • Jobst pressure garments
  • Medical Z pressure garments
  • Pressure garments
Device: Medical Z pressure garment
Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.
Other Names:
  • Pressure garment
  • Jobst pressure garment
No Intervention: 2
No pressure garment therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in scarring between pressure garment therapy and no pressure garment therapy
Time Frame: Time of burn to 2 years post burn
Time of burn to 2 years post burn

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time of burn to 2 years post burn
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
Time of burn to 2 years post burn

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

U.S. Department of Education

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

August 1, 2005

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 12, 2008

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-126
  • NIDRR

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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