Treatment of Incontinence Associated Dermatitis - Automated

NCT03046810 | Unknown DMC

• 1 other identifier: SC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incontinence, Urinary; Dermatitis; Incontinence, Fecal

Outcome Measures

Primary Outcomes (1)

• Treatment of dermatitis

  Improvement in the Kennedy Score for Dermatitis

  6 weeks

Secondary Outcomes (2)

• Prevention of recurrent dermatitis

  12 weeks

• Improvement in quality of life

  12 weeks

Study Arms (1)

Wellness toileting system

EXPERIMENTAL

This group will use the wellness toileting system for their perineal hygiene and treatment of dermatitis

Device: Wellness toileting system

Interventions

Wellness toileting system DEVICE

This group will use the wash, dry, cleanse, and apply zinc oxide barrier spray routinely for all toileting.

Also known as: SchwabCare Wellness Toileting System

Wellness toileting system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• SchwabCare: lead

Study Sites (1)

Skyline Urology

Torrance, California, 90505, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Dermatitis; Fecal Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Richard S Tilson, MD MPH

  Director of Clinical Investigation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Silvia

CONTACT

+1 (855) 239-2106; jsilvia@schwabcare.com

Richard S Tilson, MD MPH

CONTACT

(978) 459-6737; mtilson2@lowellgi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: April 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)