An observational study in Pressure Ulcers and Tissue Injury, sponsored by Trillennium Medical Imaging, Inc.. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-04-22.
Sponsored by Trillennium Medical Imaging, Inc. · Observational
Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.
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.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's planned enrollment of 100 is below the median of 154 across 97 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →This is the only study on the registry with Trillennium Medical Imaging, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from Duke North inpatient unit 8100 or 8300. All patients admitted to the above floor will be evaluated for willingness to participate.
Exclusion Criteria:
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
This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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