Pressure Ulcer Clinical Trial
Official title:
A Total Body Wash Wipe Combined With a Genital Wipe Versus Standard Care (Water and pH Neutral Soap) for Washing of Incontinent Residents in a Long- Term Care Setting: a Multicenter Prospective Randomised Controlled Clinical Trial and Health Economical Analysis in Nursing Homes
Incontinence is a widespread problem in all health care setting. One of the main
complications of incontinence is inflammation of the skin in the genital and anal region,
also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of
pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.
The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe
versus standard care (traditional water and soap) for the prevention of IAD. The second aim
is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care,
and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for
total body wash. Other outcomes are the comfort and tolerance of both the nurses and
participants.
In this Randomized Controlled Trial, performed in 13 long-term care settings, the
participants will undergo a 30 day study period. In the experimental intervention, the
participants will be washed with body wash wipes and genital wipes. In the control group,
the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be
monitored. Subjective and objective time measurements will be performed.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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