Effectiveness of Pressure Garment Therapy After Burns

NCT ID: NCT01005732

Last Updated: 2011-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-11-30
• Study Completion Date: 2009-09-30

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.

Conditions

Hypertrophic Scarring After Burn Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Custom fabricated pressure garments

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

Intervention Type: DEVICE

Other Intervention Names

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Loren Engrav

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Burn Center

Seattle, Washington, United States

Countries

United States

References

Engrav LH, Heimbach DM, Rivara FP, Moore ML, Wang J, Carrougher GJ, Costa B, Numhom S, Calderon J, Gibran NS. 12-Year within-wound study of the effectiveness of custom pressure garment therapy. Burns. 2010 Nov;36(7):975-83. doi: 10.1016/j.burns.2010.04.014. Epub 2010 Jul 1.

Reference Type: BACKGROUND

PMID: 20537469 (View on PubMed)

Other Identifiers

H133G050022

Identifier Type: -

Identifier Source: secondary_id

NIDRR_UWashingtonBMS_pgarment

Identifier Type: -

Identifier Source: secondary_id

30336-B

Identifier Type: -

Identifier Source: org_study_id