The prevalence of incontinence and inability to maintain personal perineal hygiene increases
with higher levels of nursing care. While more than 75% of those in assisted living and home
care settings are able to independently care for themselves after toileting, up to 75% of
nursing home residents have regular episodes of urinary or fecal incontinence and require aid
with toileting. This implies that whereas incontinence is a primary diagnosis in only 10% of
nursing home admissions, it represents a major contributor to morbidity among all nursing
home residents, and with that, an important target for efforts at cost containment.
Inadequate independent perineal hygiene and dependence on caregivers for effective toileting
raises global costs and adversely affects well-being for those in assisted living and
dependent living environments. It is also associated with an increase in incontinence and
incontinence associated dermatitis, which carries higher risks of urinary tract infection and
skin infection. Finally, in many institutions, loss of toileting independence mandates a
shift to a higher intensity environment, and with that incurs significant cost.
Water-based toileting has been evaluated as a potential intervention for nursing home
residents with impaired toileting capacity. In that study, while investigators found
significant overall improvement those using the device, less than half were neither
effectively cleaned nor dry at the end of use. Because of this limited reliability, currently
available devices are not thought to offer enough significant advantages for routine use in
nursing home settings.
Incontinence and incontinence associated dermatitis (IAD) is common among residents with
impaired perineal hygiene and toileting. Adherence to prescribed medications and therapies
directed at the perineum is a major barrier to regular use among those with fecal or urinary
incontinence. Difficulty in accessing the perineum make adherence challenging to those with
both full and limited mobility, often requiring assistance from a caregiver. The associated
loss of independence and dignity are major detriments to quality of life. Novel formulations
of zinc oxide, using aerosol based spray application, facilitate use and improve patient
acceptance. In a 2014 nursing home based industry study, spray based zinc oxide was preferred
by 80% of patients and caregivers, and improved treatment and prevention of IAD in 70% of the
study participants.
Adequate cleansing and drying prior to the application of barrier products is key to
effective prevention of skin breakdown. Water-based cleaning of the perineum after toileting
has been demonstrated to improve hygiene over standard mechanical, paper-based cleansing,
especially in those with limited mobility or incontinence. Evidence further demonstrates that
the addition of pH balanced cleansers, applied without mechanical abrasion from cloths or
wipes, advances hygiene and minimizes risk of secondary infection.
Study Aims
The aims of this study are to evaluate whether an automated delivery system for cleansing the
perineum can keep subjects who would normally move to higher levels of assistance at lower
levels of nursing care. A secondary aim will be to evaluate whether an automated hands-free
application of zinc oxide barrier spray effectively treats and prevents incontinence
associated dermatitis in a population with active or recurrent IAD. Finally, the study aims
to demonstrate cost savings through a cost effectiveness analysis.