Trial Outcomes & Findings for Measuring Wounds Found on the Outside of the Body Surface (NCT NCT01869439)
NCT ID: NCT01869439
Last Updated: 2017-12-06
Results Overview
Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
90 Days
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
Wounds Measures of LxW Ruler & Software LxW, Area & Perimeter
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
"gold standard" LxW manual ruler measurement technique: Currently, the "gold standard" LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).
WMMS ImageReview software's LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).
WMMS ImageReview software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measuring Wounds Found on the Outside of the Body Surface
Baseline characteristics by cohort
| Measure |
External Wounds Measured for Length by Width Using a Ruler
n=40 Participants
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
"gold standard" LxW manual ruler measurement technique: The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).
LxW measurement technique: This software measurement technique measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).
Visual External Wound Trace: This software measurement enables the user to trace the perimeter edge of the wound's visual image.
External Wound Trace Overlay: This software measurement utilizes the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, data such as the differences in the thermal intensities (gradiency), mean, and the mode of the thermal wound bed can be measured.
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|---|---|
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Age, Customized
>18 years
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40 Participants
n=5 Participants
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Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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20 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 90 DaysPopulation: 40 wounds captured in an inpatient and outpatient population.
Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.
Outcome measures
| Measure |
Wounds Measured for Length by Width Using a Ruler and Software
n=40 Participants
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
The "gold standard" LxW manual ruler measurement technique: Currently, the "gold standard" LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).
Software LxW measurement technique: This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).
Software's Visual External Wound Trace: This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.
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|---|---|
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Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Between Reader Software LxW Area
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20.07 percentage of CV
Geometric Coefficient of Variation 16.71
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Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Between Reader Software Trace Area
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16.28 percentage of CV
Geometric Coefficient of Variation 16.10
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Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Between Reader Software Perimeter
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16.28 percentage of CV
Geometric Coefficient of Variation 5.82
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Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Within Reader Software Trace Area
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20.07 percentage of CV
Geometric Coefficient of Variation 8.68
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Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Within Reader Area by Software Measurement
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16.28 percentage of CV
Geometric Coefficient of Variation 6.46
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Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Within Reader Software Perimeter
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16.28 percentage of CV
Geometric Coefficient of Variation 3.32
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Adverse Events
External Wounds Measured for Length by Width Using a Ruler
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60