Effectiveness of Pressure Garment Therapy After Burns

Effectiveness of Pressure Garment Therapy After Burns

Sponsors

Lead Sponsor: University of Washington

Source University of Washington
Brief Summary

Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns. Background - Approximately one million people are burned each year in the United States. The most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that interferes with work and all other aspects of life. Pressure garment therapy is routinely used to minimize hypertrophic scarring even though there is no scientifically valid data that this therapy is efficacious. Pressure garments are extremely unattractive, expensive and uncomfortable and their use needs to be based upon valid data. Goals and Objectives - The investigators plan to determine the effectiveness of pressure garment therapy in the control of hypertrophic scarring in healed burns. Methods - The I-Scan® device was designed to measure pressure at the body/environment interface and allows clinicians to deal with pressure-related problems for at-risk patients. It has been widely used in rehabilitation medicine but not with burn survivors. The investigators will use this device to measure the pressure at the garment/skin interface. 2) Furthermore, the few studies that have been attempted to determine efficacy have used between subjects designs. Since burn depth is extremely variable from patient to patient and since hypertrophic scarring is greatly influenced by age and race/origin, the between subjects design requires very large numbers of subjects. The investigators will use a within wounds design studying forearm burns and applying pressure to half of the wound and no pressure to the other half. The investigators will then compare hardness, color, thickness and clinical appearance.

Overall Status Completed
Start Date 1995-11-01
Completion Date 2009-09-01
Primary Completion Date 2009-09-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pressure Under Compression Garment Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Secondary Outcome
Measure Time Frame
Durometer (Hardness) of Wound Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Color of Wound Approximately12 months (follow-up visits 5)
Thickness of Wound Approximately 12 months (follow-up visit 5)
Clinical Appearance of Wound Approximately 12 months (follow-up visit 5)
Compliance With Wearing Compression Garment About 12 months (follow-up visit 5)
Enrollment 67
Condition
Intervention

Intervention Type: Device

Intervention Name: Custom fabricated pressure garments

Description: Cloth garments designed to apply 17-24 mmHg pressure to the 1/2 the burn wound and <5 mmHg to the other half, to be worn 23 hours per day until wounds mature, approximately 12 months

Other Name: Medical Z (Medical Z, San Antonio, TX)

Eligibility

Criteria:

Inclusion Criteria: - Treated from time of burn at the University of Washington Burn Center during the first two years of the grant period - Burns covering the majority of the forearm that healed spontaneously in three or more weeks. Patients will be entered into the study within 4 weeks of injury. - Age 7-65 years. Patients younger than 7 years will be excluded given the cooperation required during follow-up evaluations. Patients over 65 years will be excluded since the incidence of hypertrophic scarring in persons over 65 is too low to warrant pressure garment trials. - Patients of any race, ethnicity, or skin color. - Informed, written consent in accord with the rules of the Human Subjects Committee of the University of Washington and the Health Insurance Portability and Accountability Act (HIPAA). Exclusion Criteria: - Incarcerated patients - Homeless patients - Patients with substance abuse - Patients with psychiatric diagnosis - Patients unavailable to return regularly for follow-up evaluations

Gender:

All

Minimum Age:

7 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Loren Engrav Principal Investigator University of Washington
Location
Facility: University of Washington Burn Center
Location Countries

United States

Verification Date

2011-04-01

Responsible Party

Name Title: Dr. Loren Engrav

Organization: University of Washington

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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