Pressure Ulcer Clinical Trial
Official title:
Effectiveness of a Pressure-sensing System to Reduce the Risk of Pressure Ulcer Formation by Lowering Interface Pressure in Vulnerable Patient Populations: A Parallel-two-group Randomized Controlled Trial
Pressure ulcers are prevalent conditions that result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. This study is a parallel two-group randomized controlled trial that aims to study how the use of a pressure sensing device with continuous visual feedback of pressure imaging may potentially decrease the interface pressure of patients who are at risk of pressure ulcers in an acute hospital setting.
Background: Pressure ulcers result in substantial financial costs to the healthcare system as
well as significant distress to affected patients and their families. As interface pressure
is a key risk factor in the development of pressure ulcers, continuous visual feedback of
continuous pressure imaging (CPI) between the body and support surface could inform
healthcare providers on repositioning strategies and play a key role in an overall strategy
for the prevention and management of pressure ulcers. This randomized, controlled trial aims
to study the effect of CPI on the reduction of interface pressure, and the incidence of
pressure ulcers in vulnerable hospital patients.
Methods: A parallel two-group randomized controlled clinical trial will be conducted. A total
of 678 eligible consenting inpatients at high risk of pressure ulcer development in a
tertiary acute care institution will be randomly allocated to either have the ForeSite PT™
system with the liquid-crystal display ("LCD") monitor turned on to provide visual feedback
through CPI to healthcare providers while also collecting continuous interface pressure data
(intervention group), or have the ForeSite PT™ system with the LCD monitor turned off,
therefore not providing visual feedback or CPI to healthcare providers, while collecting
continuous interface pressure data in the background (control group), in a ratio of 1:1. Data
will be collected on both groups for three days (72 hours). The primary outcome will be the
differences in the two groups' interface pressure analysis. The interface pressure readings
will be collected through hourly sampling of continuous interface pressure recordings taken
throughout this study period. Clinical outcomes will be the differences in the two groups'
pressure-related skin and soft tissue change in areas at risk of pressure ulcer. It will be
obtained at baseline (within 24 hours of admission) and on the third day of the trial.
Perceptions of intervention patients and healthcare providers will be obtained on the third
day.
Discussion: This will be the first randomized controlled trial to investigate the effect of
CPI on interface pressure of vulnerable hospital patients, and the association between
interface pressure and development of pressure-related skin and soft tissue changes. The
results could provide important information to guide clinical practice in the prevention and
management of pressure ulcers.
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