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.