Treatment of Incontinence Associated Dermatitis - Automated

NCT ID: NCT03046810

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-09-30

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.

Detailed Description

Incontinence and incontinence associated dermatitis (IAD) are common problems. A recent CDC study noted that up to 50% of noninstitutionalized patients aged 65 and older experienced episodes of incontinence at least monthly, and that 40% of those with incontinence develop secondary IAD The treatment of IAD is focused on effective cleaning and prevention of further exposure to irritant liquids and solids through barrier creams. Enzymatic washes have proven efficacy over soap and water, and zinc oxide is the standard of care for barrier function. Combined, effective cleansing and barrier use treats IAD in as little as 6 days, and effectively prevents recurrent skin damage. In one study, an effective preventive regimen of regularly applied skin therapy reduced the incidence of IAD in an at risk population from 25% to 5%. The combination of enzymatic skin cleanser and barrier protection is the standard of care for maintenance of skin integrity in patients with chronic urinary and fecal incontinence.

Adherence to prescribed regimens is a major barrier to regular use of substances applied to the perineum. 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 the efficacy of an automated delivery system for cleansing the perineum, and applying zinc oxide barrier spray to effectively treat and prevent incontinence associated dermatitis in a population with active or recurrent IAD. Secondary aims will be to assess preference for the automated delivery system over standard wash and manually applied barrier sprays.

Conditions

Incontinence, Urinary; Dermatitis; Incontinence, Fecal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wellness toileting system

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

Group Type: EXPERIMENTAL

Wellness toileting system

Intervention Type: DEVICE

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

Interventions

Wellness toileting system

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

Intervention Type: DEVICE

Other Intervention Names

SchwabCare Wellness Toileting System

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SchwabCare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard S Tilson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Director of Clinical Investigation

Locations

Skyline Urology

Torrance, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacqueline Silvia

Role: CONTACT

jsilvia@schwabcare.com

+1 (855) 239-2106

Richard S Tilson, MD MPH

Role: CONTACT

mtilson2@lowellgi.com

(978) 459-6737

Facility Contacts

Jacqueline Silvia

Role: primary

Other Identifiers

SC-01

Identifier Type: -

Identifier Source: org_study_id