Pressure Ulcer Clinical Trial
Official title:
Pressure Ulcer Prevention Using Static Air Support Devices (Repose®) Versus Alternating-Pressure Devices in a High Risk Population in Nursing Homes: A Multi-Center Prospective Randomized Controlled Trial and Qualitative Study
Maintaining and improving skin health are major goals in acute and long-term care. Patients
at the extremes of age, the critically ill, medically compromised and those with immobility
are at risk for developing several skin disorders, with pressure ulcers (PUs) as one of the
most common and mostly preventable ones. Prevalence figures of PUs vary between 6.4% and
31.4%. PUs are described as localised injuries to the skin and/or underlying tissue, usually
over a bony prominence, as a result of pressure or pressure combined with shear. Prevention
of PUs is internationally seen to be a key quality indicator of care. To prevent PUs,
reducing both the amount and the duration of pressure and shear at the pressure points of the
body is strongly recommended. One of the interventions to achieving this, is the use of
pressure-reducing devices (mattresses, cushions, etc.). Studies that compare the (cost-)
effectiveness of different pressure-reducing devices are needed.
The primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer
prevention in high risk patients using static air support devices (Repose®) versus
alternating-pressure devices. The second aim is to get insight in patients' experiences and
perceptions of comfort using static air support devices and alternating-pressure devices. The
third aim is to get insight in caretakers' perceptions of barriers and facilitators of the
use of static air support devices and alternating-pressure devices and to reveal how these
perceptions influence the readiness to use the products in clinical practice.
This randomized controlled trial will be performed in ca. 25 nursing homes in a random sample
of 306 residents who are at high risk of developing pressure ulcers. Residents will be
included in the study for a period of 14 days. Skin assessment and risk factor registration
will be done on a daily basis by the nurses. Reliability checks and time measurements will be
completed by the researcher.
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