The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury
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|ClinicalTrials.gov Identifier: NCT00664235|
Recruitment Status : Unknown
Verified April 2008 by Trillennium Medical Imaging, Inc..
Recruitment status was: Recruiting
First Posted : April 22, 2008
Last Update Posted : April 22, 2008
|Condition or disease|
|Pressure Ulcers Tissue Injury|
The Trillennium Medical Imaging system will be used to gather skin temperature data on 100 subjects. The subjects will be enrolled from Duke North floors 8100 or 8300 in a prospective controlled trial. All eligible patients who have signed a consent form will be assessed using the Long Wave Infrared imaging.
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Study of Thermal Imaging as an Objective RISK Indicator; The Evaluation of Skin Blood Flow and Temperature by Long Wave Infra-Red Imaging to Determine Effectiveness as a Predictor of Pressure Ulcer or Non-Visible Deep Tissue Damage|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||April 2008|
|Estimated Study Completion Date :||June 2008|
- Each time a pattern of injury is identified by the device, we will correlate this occurrence with the Braden scale to see whether or not it suggested an injury potential. [ Time Frame: 90 days ]
- It is our hypothesis that the pattern of injury will develop without warning from the Braden scores. [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664235
|Contact: David W Judy, D.O.||firstname.lastname@example.org|
|Contact: Edna E Atwateremail@example.com|
|United States, North Carolina|
|Duke University Health System||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: David W. Judy, D.O. 919-668-0145 firstname.lastname@example.org|
|Principal Investigator: Claude S. Burton, M.D.|
|Principal Investigator:||Claude S. Burton, M.D.||Duke University Health System|