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NCT01005732 · ClinicalTrials.gov registry record · NA
Effectiveness of Pressure Garment Therapy After Burns
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT01005732 is a NA study that has completed, run by University of Washington. The registered enrollment target is 67 participants.
The verdict
NCT01005732, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Custom fabricated pressure garments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 1995-11 |
| Est. Completion | 2009-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01005732
The ClinicalTrials.gov registry entry for NCT01005732 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Custom fabricated pressure garments is the first listed.
NCT01005732 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01005732 about?
NCT01005732 is a clinical study titled "Effectiveness of Pressure Garment Therapy After Burns". 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, hype...
What is the current status of trial NCT01005732?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 1995-11. Estimated completion is 2009-09.
What interventions are being tested in trial NCT01005732?
The interventions under investigation include: Custom fabricated pressure garments (DEVICE).
Who is sponsoring clinical trial NCT01005732?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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