Use of Pressure Garments for Burn Scars (Jobst)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00675974
First received: December 26, 2007
Last updated: November 13, 2012
Last verified: November 2012
  Purpose
  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.

Condition Intervention Phase
Burns
Device: Jobst Pressure Garment
Device: Medical Z pressure garment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Differences in scarring between pressure garment therapy and no pressure garment therapy [ Time Frame: Time of burn to 2 years post burn ] [ Designated as safety issue: No ]

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. [ Time Frame: Time of burn to 2 years post burn ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Medical Z pressure garment
  • Jobst pressure garment
No Intervention: 2
No pressure garment therapy

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675974

Sponsors and Collaborators
The University of Texas, Galveston
U.S. Department of Education
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00675974     History of Changes
Other Study ID Numbers: 05-126, NIDRR
Study First Received: December 26, 2007
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Burn
Scar
Pressure garments
Wound healing
Burn Injury

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 20, 2014