Clinical trial NCT02475512: Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Irritant Contact Dermatitis Due to Incontinence
Diaper Rash
Pressure Ulcer
Incontinence-associated Dermatitis
Keywords: elderly
long-term care
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2015-06-18
Enrollment: 385
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and category of Incontinence-Associated Dermatitis
timeFrame: within the first 30 days after start of the study
Secondary outcomes:
measure: Incidence and category of Pressure Ulcers
timeFrame: within the first 30 days after start of the study
measure: Comfort and tolerance of the participant
timeFrame: On baseline, at day 14 and at day 30 (the end of the study)
measure: Comfort and preferences of the caregiver
timeFrame: On baseline, at day 14 and at day 30 (the end of the study)
measure: adverse effects of the intervention
timeFrame: within the first 30 days after start of the study
measure: Cost of the experiment (use of wash wipes) versus the standard care
timeFrame: For the duration of the study (30 days)
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Woonzorgcentrum Sint-Jozef
city: Harelbeke
country: Belgium
facility: Woonzorgcentrum Ceder aan de Leie
city: Kortrijk
country: Belgium
facility: Woonzorgcentrum Heilig Hart
city: Kortrijk
country: Belgium
facility: Woonzorgcentrum Sint-Jozef
city: Nukerke
country: Belgium
facility: Woonzorgcentrum De Samaritaan
city: Oostende
country: Belgium
facility: Woonzorgcentrum de Boarebreker
city: Sint-Gillis-Waas
country: Belgium
facility: Woonzorgcentrum De Kroon
city: Tielt
country: Belgium
facility: Woonzorgcentrum Deken Darras
city: Wakken
country: Belgium
facility: Woonzorgcentrum Onze Lieve Vrouw van Lourdes
city: Wenduine
country: Belgium
facility: Woonzorgcentrum Duneroze
city: Wevelgem
country: Belgium
facility: Woonzorgcentrum Sint-Camillus
Study officials:
affiliation: University Ghent
name: Dimitri Beeckman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.