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
2 other identifiers
interventional
385
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 21, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 9, 2016
February 1, 2016
7 months
May 21, 2015
February 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and category of Incontinence-Associated Dermatitis
within the first 30 days after start of the study
Secondary Outcomes (5)
Incidence and category of Pressure Ulcers
within the first 30 days after start of the study
Comfort and tolerance of the participant
On baseline, at day 14 and at day 30 (the end of the study)
Comfort and preferences of the caregiver
On baseline, at day 14 and at day 30 (the end of the study)
adverse effects of the intervention
within the first 30 days after start of the study
Cost of the experiment (use of wash wipes) versus the standard care
For the duration of the study (30 days)
Study Arms (2)
Wash wipes
EXPERIMENTALWashing 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.
Standard care
PLACEBO COMPARATORWashing will be done using water and pH neutral soap. No other preventive barrier or hydration products will be allowed in the genital-anal region.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- 3Mcollaborator
Study Sites (11)
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, 9681, 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
Related Publications (1)
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.
PMID: 24700170BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitri Beeckman, PhD
University Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Centre for Nursing and midwifery
Study Record Dates
First Submitted
May 21, 2015
First Posted
June 18, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 9, 2016
Record last verified: 2016-02