The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury
NCT ID: NCT00664235
Last Updated: 2008-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2008-02-29
2008-06-30
Brief Summary
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Detailed Description
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Subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. Subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. The intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. The subjects who already have an ulcer will only be scanned on non ulcerated tissue. The areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. The device will be held approximately 36 inches from the area of interest in order to obtain an image. The subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. The subject's routinely recorded Braden scores (By on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the Imaging system. The nurse conducting the imaging will also record a Braden score.
All subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Trillennium Medical Imaging, Inc.
INDUSTRY
Responsible Party
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Duke University Medical Center
Principal Investigators
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Claude S. Burton, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Health System
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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David W. Judy, D.O.
Role: primary
Other Identifiers
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Pro00003228
Identifier Type: -
Identifier Source: org_study_id