- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02475512
Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly
A Total Body Wash Wipe Combined With a Genital Wipe Versus Standard Care (Water and pH Neutral Soap) for Washing of Incontinent Residents in a Long- Term Care Setting: a Multicenter Prospective Randomised Controlled Clinical Trial and Health Economical Analysis in Nursing Homes
Incontinence is a widespread problem in all health care setting. One of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.
The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus standard care (traditional water and soap) for the prevention of IAD. The second aim is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.
In this Randomized Controlled Trial, performed in 13 long-term care settings, the participants will undergo a 30 day study period. In the experimental intervention, the participants will be washed with body wash wipes and genital wipes. In the control group, the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be monitored. Subjective and objective time measurements will be performed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brugge, Belgium
- Woonzorgcentrum Sint-Jozef
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Harelbeke, Belgium
- Woonzorgcentrum Ceder aan de Leie
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Kortrijk, Belgium
- Woonzorgcentrum Heilig Hart
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Kortrijk, Belgium
- Woonzorgcentrum Sint-Jozef
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Nukerke, Belgium, 9681
- Woonzorgcentrum De Samaritaan
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Oostende, Belgium
- Woonzorgcentrum de Boarebreker
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Sint-Gillis-Waas, Belgium
- Woonzorgcentrum De Kroon
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Tielt, Belgium
- Woonzorgcentrum Deken Darras
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Wakken, Belgium
- Woonzorgcentrum Onze Lieve Vrouw van Lourdes
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Wenduine, Belgium
- Woonzorgcentrum Duneroze
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Wevelgem, Belgium
- Woonzorgcentrum Sint-Camillus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- urinary incontinence, fecal incontinence or double incontinence
- depending on help for washing
- free of skin damage (without signs of pressure ulcers or IAD such as skin breakdown or redness)
Exclusion Criteria:
- not incontinent or minor incontinent (e.g. stress incontinence)
- urinary or fecal catheter
- use of incontinence wipes in the uro-genital area two weeks prior to the start of the study
- the use of a skin barrier product in the uro-genital area two weeks prior to screening
- presence of a bacterial/fungal infection in the uro-genital area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Wash wipes
Washing with water and soap (standard care) will be replaced with two wash wipes during 30 days: (1) daily total body wash (using 3M Cavilon Bathing and Cleansing wipes) and (2) Continence Care (using 3M Cavilon Continence Care Wipes).
No other preventive barrier or hydration products will be allowed in the genital-anal region.
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Other Names:
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Placebo Comparator: Standard care
Washing will be done using water and pH neutral soap.
No other preventive barrier or hydration products will be allowed in the genital-anal region.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and category of Incontinence-Associated Dermatitis
Time Frame: within the first 30 days after start of the study
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within the first 30 days after start of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and category of Pressure Ulcers
Time Frame: within the first 30 days after start of the study
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within the first 30 days after start of the study
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Comfort and tolerance of the participant
Time Frame: On baseline, at day 14 and at day 30 (the end of the study)
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Questions on comfort and tolerance of the washing method will be assessed by the caregiver.
At baseline (day 0) these questions will assess the traditional care.
In the middle (day 14) and at the end of the study (day 30) the comfort and tolerance of washing with wash wipes will be assessed in the experimental group.
In the control group, comfort and tolerance of traditional care will be assessed three times.
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On baseline, at day 14 and at day 30 (the end of the study)
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Comfort and preferences of the caregiver
Time Frame: On baseline, at day 14 and at day 30 (the end of the study)
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Questions on comfort and preferences of the washing method will be assessed.
At baseline (day 0) these questions will assess the traditional care.
In the middle (day 14) and at the end of the study (day 30) the comfort and preferences of washing with wash wipes will be assessed.
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On baseline, at day 14 and at day 30 (the end of the study)
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adverse effects of the intervention
Time Frame: within the first 30 days after start of the study
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Adverse effects such as skin irritation, rash, itching, treatment related pain, skin dryness related to the interventions under study will be monitored.
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within the first 30 days after start of the study
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Cost of the experiment (use of wash wipes) versus the standard care
Time Frame: For the duration of the study (30 days)
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For the duration of the study (30 days)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/0277 (OTHER: CEIC)
- B670201524231 (Other Identifier: Ethics Committee UZ Gent)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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