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Behavioural Intervention

Wellness toileting system for Acneiform Dermatitis (TRIAD-A Trial)

N/A
Waitlist Available
Led By Richard S Tilson, MD MPH
Research Sponsored by SchwabCare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Acneiform Dermatitis
  • Bullous Dermatitis
  • Fecal Incontinence
  • Urinary Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment of dermatitis
Secondary study objectives
Improvement in quality of life
Prevention of recurrent dermatitis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Wellness toileting systemExperimental Treatment1 Intervention
This group will use the wellness toileting system for their perineal hygiene and treatment of dermatitis

Find a Location

Who is running the clinical trial?

SchwabCareLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Richard S Tilson, MD MPHPrincipal InvestigatorDirector of Clinical Investigation
1 Previous Clinical Trials
40 Total Patients Enrolled
~5 spots leftby Nov 2025