Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly
NCT ID: NCT02475512
Last Updated: 2016-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
385 participants
INTERVENTIONAL
2015-05-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Wash wipes (3M)
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.
water and pH neutral soap
Interventions
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Wash wipes (3M)
water and pH neutral soap
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* depending on help for washing
* free of skin damage (without signs of pressure ulcers or IAD such as skin breakdown or redness)
Exclusion Criteria
* 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
65 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
University Ghent
OTHER
Responsible Party
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UCVV
University Centre for Nursing and midwifery
Principal Investigators
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Dimitri Beeckman, PhD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Woonzorgcentrum Sint-Jozef
Bruges, , Belgium
Woonzorgcentrum Ceder aan de Leie
Harelbeke, , Belgium
Woonzorgcentrum Heilig Hart
Kortrijk, , Belgium
Woonzorgcentrum Sint-Jozef
Kortrijk, , Belgium
Woonzorgcentrum De Samaritaan
Nukerke, , Belgium
Woonzorgcentrum de Boarebreker
Ostend, , Belgium
Woonzorgcentrum De Kroon
Sint-Gillis-Waas, , Belgium
Woonzorgcentrum Deken Darras
Tielt, , Belgium
Woonzorgcentrum Onze Lieve Vrouw van Lourdes
Wakken, , Belgium
Woonzorgcentrum Duneroze
Wenduine, , Belgium
Woonzorgcentrum Sint-Camillus
Wevelgem, , Belgium
Countries
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References
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Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A systematic review and meta-analysis of incontinence-associated dermatitis, incontinence, and moisture as risk factors for pressure ulcer development. Res Nurs Health. 2014 Jun;37(3):204-18. doi: 10.1002/nur.21593. Epub 2014 Apr 3.
Related Links
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Website of the research group
Other Identifiers
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B670201524231
Identifier Type: OTHER
Identifier Source: secondary_id
2015/0277
Identifier Type: -
Identifier Source: org_study_id
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