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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: Completed NA study, sponsored by University of Washington.

NCT01005732 is a NA study that has completed, run by University of Washington. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

Interventions

  • DEVICE Custom fabricated pressure garments

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 1995-11
Est. Completion 2009-09
Phase NA
University of Washington

1,048 total trials

What the finished NCT01005732 record still lists

NCT01005732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Custom fabricated pressure garments is the first listed.

NCT01005732 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01005732's enrollment target sits among peer trials

67 1139th of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01005732, the US trial registry maintained by the National Library of Medicine. NCT01005732 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.