Use of Pressure Garments for Burn Scars - Full Text View

Use of Pressure Garments for Burn Scars (Jobst)

This study is currently recruiting participants.

Verified by The University of Texas, Galveston, February 2009

First Received: December 26, 2007 Last Updated: February 17, 2009 History of Changes

Sponsors and Collaborators:	The University of Texas, Galveston National Institute of Disability and Rehabilitation Research
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00675974

Purpose

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.

Condition	Intervention	Phase
Burns	Device: Jobst Pressure Garment Device: Medical Z pressure garment	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Project 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:

MedlinePlus related topics: Burns Scars

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 pruitis compared to no pressure garment therapy [ Time Frame: Time of burn to 2 years post burn ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. 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.
2: No Intervention No pressure garment therapy

Eligibility

Criteria

Inclusion Criteria:

At least 30% 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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675974

Contacts

Contact: David N Herndon, MD	409-770-6731	dherndon@utmb.edu
Contact: Deb A Benjamin, RN, MSN	409-770-6731	dbenjami@utmb.edu

Locations

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Deb A Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu
Contact: Carole J Miller 409-770-6728 cmiller@utmb.edu
Principal Investigator: David N Herndon, MD

Sponsors and Collaborators

The University of Texas, Galveston

National Institute of Disability and Rehabilitation Research

Investigators

Principal Investigator:

David N Herndon, MD

University of Texas

More Information

No publications provided

Responsible Party:	University of Texas Medical Branch, Galveston ( David N. Herndon, MD )
Study ID Numbers:	05-126, NIDRR
Study First Received:	December 26, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00675974 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

Burn
Scar
Pressure garments
Wound healing
Burn Injury

Study placed in the following topic categories:

Burns
Hypertrophy
Cicatrix

ClinicalTrials.gov processed this record on September 10, 2009