Pressure Ulcer Clinical Trial
Official title:
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
Verified date | February 2016 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 385 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | Woonzorgcentrum Sint-Jozef | Brugge | |
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 | Oostende | |
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 |
Lead Sponsor | Collaborator |
---|---|
University Ghent | 3M |
Belgium,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and category of Incontinence-Associated Dermatitis | within the first 30 days after start of the study | No | |
Secondary | Incidence and category of Pressure Ulcers | within the first 30 days after start of the study | No | |
Secondary | Comfort and tolerance of the participant | 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. | On baseline, at day 14 and at day 30 (the end of the study) | No |
Secondary | Comfort and preferences of the caregiver | 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. | On baseline, at day 14 and at day 30 (the end of the study) | No |
Secondary | adverse effects of the intervention | Adverse effects such as skin irritation, rash, itching, treatment related pain, skin dryness related to the interventions under study will be monitored. | within the first 30 days after start of the study | No |
Secondary | Cost of the experiment (use of wash wipes) versus the standard care | recording the daily consumption of towels, wash wipes,... subjective time analyses of the washing methods: Estimated time registration by the caregiver objective time analyses of the washing methods: time registration using a chronometer, conducted by researcher retrieval of overhead costs related to traditional hygienic care: washing equipment purchase costs, general water and electricity: given per institution |
For the duration of the study (30 days) | No |
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