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Effectiveness of Pressure Garment Therapy After Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005732
Recruitment Status : Completed
First Posted : November 1, 2009
Results First Posted : April 4, 2011
Last Update Posted : April 4, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertrophic Scarring After Burn Injury Device: Custom fabricated pressure garments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Pressure Garment Therapy After Burns
Study Start Date : November 1995
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

Intervention Details:
  • Device: 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
    Other Name: Medical Z (Medical Z, San Antonio, TX)

Primary Outcome Measures :
  1. Pressure Under Compression Garment [ Time Frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5) ]
    Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits.

Secondary Outcome Measures :
  1. Durometer (Hardness) of Wound [ Time Frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5) ]
    A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in "durometer units" (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.

  2. Color of Wound [ Time Frame: Approximately12 months (follow-up visits 5) ]
    A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L*a*b* color space was described by The Commission Internationale de I'Eclairage (CIE)(L=brightness [100=white,0=black], a=red-green[red=60,green=-60], b=yellow-blue[yellow=60,blue=-60])

  3. Thickness of Wound [ Time Frame: Approximately 12 months (follow-up visit 5) ]
    Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.

  4. Clinical Appearance of Wound [ Time Frame: Approximately 12 months (follow-up visit 5) ]
    Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or "no difference") that the indicated zone had the better appearance.

  5. Compliance With Wearing Compression Garment [ Time Frame: About 12 months (follow-up visit 5) ]
    The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005732

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United States, Washington
University of Washington Burn Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
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Principal Investigator: Loren Engrav University of Washington
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Responsible Party: Dr. Loren Engrav, University of Washington Identifier: NCT01005732    
Other Study ID Numbers: 30336-B
First Posted: November 1, 2009    Key Record Dates
Results First Posted: April 4, 2011
Last Update Posted: April 4, 2011
Last Verified: April 2011
Keywords provided by University of Washington:
Additional relevant MeSH terms:
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Cicatrix, Hypertrophic
Wounds and Injuries
Pathological Conditions, Anatomical
Pathologic Processes