Edema

Water Retention

Clinical Trial: Hand Edema in Burn Patients

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Purpose
Eligibility
Location Information
More Information

This study is no longer recruiting patients.

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00137228

Purpose

To determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. Establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.

Condition	Intervention
Edema	Procedure: figure-of-eight hand measurements Procedure: water volumetry hand measurements

MedlinePlus related topics: Edema

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title: The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries

Further Study Details:

Primary Outcomes: The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.
Expected Total Enrollment: 33

Study start: January 2005; Study completion: February 2006
Last follow-up: February 2006; Data entry closure: February 2006

A prospective study involving 33 burn patients admitted to the US Army Burn Center. Two raters will perform three separate blinded measurements for hand edema using the figure-of-eight measurement technique. A third rater will then perform two blinded measurements using water volumetry. All measurements will be read and recorded by an independent recorder. The three measurements of rater 1 and 2 will be analyzed to determine intratester reliability. The average of the three figure-of-eight measurements will be compared to measure intertester reliability. The two volumetry measurements will be compared to determine intratester reliability. The average of the 2 volumetry measurements and the average fo the three figure-of-eight measurements will be used to determine concurrent validity.

Eligibility

Ages Eligible for Study: 18 Years - 89 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

male or female 18-89 years old
Admitted to the US Army Burn ICU or ward with burn injury and the presence of bilateral or unilateral hand edema

Exclusion Criteria:

Subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician that precludes the safe use of volumetry.
Subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing.
Subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement

Location Information

Texas
U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas, 78234, United States

Study chairs or principal investigators

Scott Dewey, PT, CHT, OCS, Principal Investigator, US Army Institute of Surgical Research

More Information

Publications

Leard JS, Breglio L, Fraga L, Ellrod N, Nadler L, Yasso M, Fay E, Ryan K, Pellecchia GL. Reliability and concurrent validity of the figure-of-eight method of measuring hand size in patients with hand pathology. J Orthop Sports Phys Ther. 2004 Jun;34(6):335-40.

Study ID Numbers: H-04-030
Last Updated: August 26, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00137228
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13

Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Hand Edema in Burn Patients - Article

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Edema

Water Retention

Clinical Trial: Hand Edema in Burn Patients

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Location Information

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Hand Edema in Burn Patients - Article

General Topics A-Z

Edema

Water Retention

Clinical Trial: Hand Edema in Burn Patients

Jump to Section

Purpose

Eligibility

Location Information

More Information

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