Maintaining Lower Levels of Care Through Automated Perineal Hygiene

Status unconfirmed · Not applicable

Conditions studied: Incontinence, Dermatitis

In brief

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.

Key facts

Study ID

NCT03051321

Run by

SchwabCare

People needed

40

Starts

2017-04-01

Expected to finish

2018-10-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Canterbury — Rancho Palos Verdes, California, United States (enrolling)
• The Village at Marymount — Garfield Heights, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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