Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137228
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2005-08-25
Brief Title:
Measuring Hand Edema in Burn Patients
Sponsor:
United States Army Institute of Surgical Research
Organization:
United States Army Institute of Surgical Research
Study Overview
Official Title:
The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None