Maintaining Lower Levels of Care Through Automated Perineal Hygiene
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/1/2018 |
| Start Date: | April 1, 2017 |
| End Date: | October 2018 |
| Contact: | Jacqueline Silvia |
| Email: | jsilvia@schwabcare.com |
| Phone: | (855) 239-2106 |
The inability to independently manage perineal hygiene after toileting is a common issue for
those in assisted living and nursing home environments. It is associated with skin breakdown
(dermatitis), increased nursing costs, and loss of patient self-esteem and independence.
Water-based toileting has been evaluated as a possible adjunct to patient care, but its
uptake has been limited by ineffective cleansing and drying.
40 subjects with limitations in independent capacity for perineal hygiene that require
assistance with toileting will be recruited from a continued care retirement center. Subjects
will be assessed for incontinence, and skin breakdown or irritation. Subjects will be
provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be
applied in cases of dermatitis.
Investigators hypothesize that subjects given the device will remain more independent, with
higher quality of life. Secondary hypotheses are that subjects will experience improved
relationships with their caregivers, and that active dermatitis will be treated in those
already with the condition, and prevented in those at risk.
those in assisted living and nursing home environments. It is associated with skin breakdown
(dermatitis), increased nursing costs, and loss of patient self-esteem and independence.
Water-based toileting has been evaluated as a possible adjunct to patient care, but its
uptake has been limited by ineffective cleansing and drying.
40 subjects with limitations in independent capacity for perineal hygiene that require
assistance with toileting will be recruited from a continued care retirement center. Subjects
will be assessed for incontinence, and skin breakdown or irritation. Subjects will be
provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be
applied in cases of dermatitis.
Investigators hypothesize that subjects given the device will remain more independent, with
higher quality of life. Secondary hypotheses are that subjects will experience improved
relationships with their caregivers, and that active dermatitis will be treated in those
already with the condition, and prevented in those at risk.
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.
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.
Inclusion Criteria:
- Limitation of Activity of Daily Living - Toileting, requiring assistance, beginning
stages of unmanaged incontinence. For the purposes of this study, toileting refers to
maintenance of hygiene and ability to clean the perineum after urination or defecation. It
does not include inability to transfer to a commode only.
Exclusion Criteria:
- Inability to obtain consent
- Weight over 300 pounds
- Prior pelvic radiation
- Pelvic Floor surgery within the 6 weeks prior to enrollment
- Active perineal infection
- Active chemotherapy
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