Measuring Hand Edema in Burn Patients

Not Applicable

Completed

• Conditions: Edema

• Registration Number: NCT00137228
• Lead Sponsor: United States Army Institute of Surgical Research

Brief Summary

The purpose of this study is 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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Study Completion: 2006-11
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-24
• Last Update Posted: 2008-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female 18-89 years old
• Admitted to the United States (U.S.) Army Burn Intensive Care Unit (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.	24 hours

Trial Locations

Locations (1)

U.S. Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States