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Maintaining Lower Levels of Care Through Automated Perineal Hygiene

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03051321
Recruitment Status : Unknown
Verified May 2018 by SchwabCare.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : May 30, 2018
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 13, 2017
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
Days Remaining in independent living environment [ Time Frame: 24 weeks ]
Subject does not require assistance for perineal hygiene that requires change of living environment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Improved quality of life [ Time Frame: 24 weeks ]
    Subject using device will experience improved quality of life derived from the quality of life in incontinence scale
  • Treatment and prevention of incontinence associated dermatitis [ Time Frame: 24 weeks ]
    Device will treat existing, and prevent dermatitis in subjects with incontinence, evaluated using the Kennedy Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Maintaining Lower Levels of Care Through Automated Perineal Hygiene
Official Title  ICMJE Maintaining Lower Levels of Care Through Automated Perineal Hygiene
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.

Detailed Description

The prevalence of incontinence and inability to maintain personal perineal hygiene increases with higher levels of nursing care. While more than 75% of those in assisted living and home care settings are able to independently care for themselves after toileting, up to 75% of nursing home residents have regular episodes of urinary or fecal incontinence and require aid with toileting. This implies that whereas incontinence is a primary diagnosis in only 10% of nursing home admissions, it represents a major contributor to morbidity among all nursing home residents, and with that, an important target for efforts at cost containment. Inadequate independent perineal hygiene and dependence on caregivers for effective toileting raises global costs and adversely affects well-being for those in assisted living and dependent living environments. It is also associated with an increase in incontinence and incontinence associated dermatitis, which carries higher risks of urinary tract infection and skin infection. Finally, in many institutions, loss of toileting independence mandates a shift to a higher intensity environment, and with that incurs significant cost.

Water-based toileting has been evaluated as a potential intervention for nursing home residents with impaired toileting capacity. In that study, while investigators found significant overall improvement those using the device, less than half were neither effectively cleaned nor dry at the end of use. Because of this limited reliability, currently available devices are not thought to offer enough significant advantages for routine use in nursing home settings.

Incontinence and incontinence associated dermatitis (IAD) is common among residents with impaired perineal hygiene and toileting. Adherence to prescribed medications and therapies directed at the perineum is a major barrier to regular use among those with fecal or urinary incontinence. 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 whether an automated delivery system for cleansing the perineum can keep subjects who would normally move to higher levels of assistance at lower levels of nursing care. A secondary aim will be to evaluate whether an automated hands-free application of zinc oxide barrier spray effectively treats and prevents incontinence associated dermatitis in a population with active or recurrent IAD. Finally, the study aims to demonstrate cost savings through a cost effectiveness analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Incontinence
  • Dermatitis
Intervention  ICMJE Device: Wellness toilet system
Water-based toileting with capacity to apply zinc oxide barrier spray to treat incontinence associated dermatitis
Other Name: SchwabCare Wellness Toileting System
Study Arms  ICMJE Experimental: Wellness toileting system
Subjects given SchwabCare Wellness Toileting system
Intervention: Device: Wellness toilet system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 8, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03051321
Other Study ID Numbers  ICMJE SC-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SchwabCare
Study Sponsor  ICMJE SchwabCare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard S Tilson, MD MPH Director of Clinical Investigation
PRS Account SchwabCare
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP