Maintaining Lower Levels of Care Through Automated Perineal Hygiene

NCT03051321 | Unknown DMC

• 1 other identifier: SC-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Incontinence; Dermatitis

Outcome Measures

Primary Outcomes (1)

• Days Remaining in independent living environment

  Subject does not require assistance for perineal hygiene that requires change of living environment

  24 weeks

Secondary Outcomes (2)

• Improved quality of life

  24 weeks

• Treatment and prevention of incontinence associated dermatitis

  24 weeks

Study Arms (1)

Wellness toileting system

EXPERIMENTAL

Subjects given SchwabCare Wellness Toileting system

Device: Wellness toilet system

Interventions

Wellness toilet system DEVICE

Water-based toileting with capacity to apply zinc oxide barrier spray to treat incontinence associated dermatitis

Also known as: SchwabCare Wellness Toileting System

Wellness toileting system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• SchwabCare: lead

Study Sites (2)

The Canterbury

Rancho Palos Verdes, California, 90275, United States

RECRUITING

The Village at Marymount

Garfield Heights, Ohio, 44125, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard S Tilson, MD MPH

  Director of Clinical Investigation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Silvia

CONTACT

(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 7, 2017
• First Posted: February 13, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)