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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):

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.

Condition or disease Intervention/treatment Phase
Incontinence Dermatitis Device: Wellness toilet system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintaining Lower Levels of Care Through Automated Perineal Hygiene
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Wellness toileting system
Subjects given SchwabCare Wellness Toileting system
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

Primary Outcome Measures :
  1. Days Remaining in independent living environment [ Time Frame: 24 weeks ]
    Subject does not require assistance for perineal hygiene that requires change of living environment

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03051321

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Contact: Jacqueline Silvia (855) 239-2106
Contact: Richard s Tilson, MD MPH (978) 459-6737

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United States, California
The Canterbury Recruiting
Rancho Palos Verdes, California, United States, 90275
Contact: Jacqualine Silvia         
United States, Ohio
The Village at Marymount Recruiting
Garfield Heights, Ohio, United States, 44125
Contact: Jacqueline Silvia         
Sponsors and Collaborators
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Principal Investigator: Richard S Tilson, MD MPH Director of Clinical Investigation
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Responsible Party: SchwabCare Identifier: NCT03051321    
Other Study ID Numbers: SC-02
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases