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EVALUATION OF A NOVEL DEVICE USING CAPACITANCE OF THE DETECTION OF EARLY PRESSURE ULCERS (PU), A MULTI-SITE LONGITUDINAL STUDY

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Evaluation of a novel device using capacitance of the detection of early pressure ulcers (PU), a multi-site longitudinal study

Henry Okonkwo(1), Jeanette Milne(2) Ruth Bryant(3)

1 Skilled Wound Care, Los Angeles, United States

2 Northumbria Healthcare NHS Foundation Trust, Northumberland, United Kingdom

3 Washington State University, College of Nursing, Spokane, United States

 

 

Clinical Trial Design: How to determine validity in the absence of an objective gold standard  

 

Challenge 1- All of the current Gold Standard tests are subjective.
Challenge 2- Intervention complexities: It is difficult to create a control study because practitioners have to intervene when PUs are deemed to have occurred or when patients are at risk.  Interventions are facility specific and not completely standardized. 
Challenge 3- Clinical study design options are limited.  A true randomized controlled trial, for example, is unfeasible.
 
•SEM is a novel device that can accurately detect developing pressure ulcers, even when there are no visible signs of damage at the surface.
• SEM can detect damage, on average, 5 days, but up to 12 days before nurse visual assessment.
• With early detection,  within the window of prevention, interventions can be applied to reverse or halt progression of damage. 
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