Treatment of Incontinence Associated Dermatitis - Automated
Status unconfirmed · Not applicable
Conditions studied: Incontinence, Urinary, Dermatitis, Incontinence, Fecal
In brief
Incontinence and the skin irritation (dermatitis) associated with it are common problems. Treatment of dermatitis is effective, but requires effective cleaning and application of a barrier substance to prevent further contact between urine or feces and the skin. Water based cleansing with the addition of a pH balanced cleanser is more effective than standard abrasive cleansing with paper or a cloth, and is better tolerated by those with skin irritation. Zinc oxide based barriers effectively promote healing and prevent further skin damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the patient to apply independently given the challenge of accessing the perineum. 40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks 1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will be measured using a visual analog scale derived from the quality of life in incontinence scale. The investigators hypothesize that the device will 1) effectively treat incontinence associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.
Key facts
- Study ID
- NCT03046810
- Run by
- SchwabCare
- People needed
- 40
- Starts
- 2017-04-01
- Expected to finish
- 2019-09-01
- Last updated by the study team
- 2018-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to give informed consent.
- Active functional urinary or fecal incontinence
- Kennedy Scale Grade >2 with active incontinence associated dermatitis
- Willingness to have device installed in home/care center
You may not qualify if…
- Active perineal infection
- Prior pelvic radiation
- Perineal surgery within the prior 6 months
- Known allergy or sensitivity to applied agents
- Treatment for dermatitis within the prior 2 weeks.
- Pre-existing pressure ulcer stage 2-4
- Weight exceeding 300 pounds
- Known allergy or hypersensitivity to cleanser or zinc oxide barrier spray
- Home bathroom needs excessive upgrades, or needs ownership authorization
Where it is running
- Skyline Urology — Torrance, California, United States (enrolling)
Full record on ClinicalTrials.gov
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