Measuring Hand Edema in Burn Patients

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137228
• Other study ID #: H-04-030
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: December 24, 2007
• Start date: January 2005
• Est. completion date: November 2006

Study information

• Verified date: December 2007
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Edema

Intervention

Procedure:
• figure-of-eight hand measurements

• water volumetry hand measurements

Locations

Country	Name	City	State
United States	U.S. Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.		24 hours