Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475512
• Other study ID #: 2015/0277
• Secondary ID: B670201524231
• Status: Terminated
• Phase: N/A
• First received: May 21, 2015
• Last updated: February 8, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Diaper Rash
• Eczema
• Incontinence-associated Dermatitis
• Irritant Contact Dermatitis Due to Incontinence
• Pressure Ulcer

Intervention

Other:
• Wash wipes (3M)

• water and pH neutral soap

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	3M

Country where clinical trial is conducted

Belgium, 

References & 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. Review. — View Citation

Outcome

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

External Links

•   Website of the research group