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

Not Applicable

Terminated

• Conditions: Irritant Contact Dermatitis Due to Incontinence; Diaper Rash; Pressure Ulcer; Incontinence-associated Dermatitis
• Interventions: Other: Wash wipes (3M); Other: water and pH neutral soap

• Registration Number: NCT02475512
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 385

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wash wipes	Wash wipes (3M)	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.
Standard care	water and pH neutral soap	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.

Primary Outcome Measures

Name	Time	Method
Incidence and category of Incontinence-Associated Dermatitis	within the first 30 days after start of the study

Secondary Outcome Measures

Name	Time	Method
Comfort and tolerance of the participant	On baseline, at day 14 and at day 30 (the end of the study)	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.
Comfort and preferences of the caregiver	On baseline, at day 14 and at day 30 (the end of the study)	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.
Cost of the experiment (use of wash wipes) versus the standard care	For the duration of the study (30 days)	* 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
Incidence and category of Pressure Ulcers	within the first 30 days after start of the study
adverse effects of the intervention	within the first 30 days after start of the study	Adverse effects such as skin irritation, rash, itching, treatment related pain, skin dryness related to the interventions under study will be monitored.

Trial Locations

Locations (10)

Woonzorgcentrum Sint-Jozef; 🇧🇪 Kortrijk, Belgium

Woonzorgcentrum Heilig Hart; 🇧🇪 Kortrijk, Belgium

Woonzorgcentrum de Boarebreker; 🇧🇪 Oostende, Belgium

Woonzorgcentrum Onze Lieve Vrouw van Lourdes; 🇧🇪 Wakken, Belgium

Woonzorgcentrum De Kroon; 🇧🇪 Sint-Gillis-Waas, Belgium

Woonzorgcentrum Deken Darras; 🇧🇪 Tielt, Belgium

Woonzorgcentrum Sint-Camillus; 🇧🇪 Wevelgem, Belgium

Woonzorgcentrum Ceder aan de Leie; 🇧🇪 Harelbeke, Belgium

Woonzorgcentrum De Samaritaan; 🇧🇪 Nukerke, Belgium

Woonzorgcentrum Duneroze; 🇧🇪 Wenduine, Belgium