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

February 8, 2016 updated by: UCVV, University Ghent

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • Woonzorgcentrum Sint-Jozef
      • Harelbeke, Belgium
        • Woonzorgcentrum Ceder aan de Leie
      • Kortrijk, Belgium
        • Woonzorgcentrum Heilig Hart
      • Kortrijk, Belgium
        • Woonzorgcentrum Sint-Jozef
      • Nukerke, Belgium, 9681
        • Woonzorgcentrum De Samaritaan
      • Oostende, Belgium
        • Woonzorgcentrum de Boarebreker
      • Sint-Gillis-Waas, Belgium
        • Woonzorgcentrum De Kroon
      • Tielt, Belgium
        • Woonzorgcentrum Deken Darras
      • Wakken, Belgium
        • Woonzorgcentrum Onze Lieve Vrouw van Lourdes
      • Wenduine, Belgium
        • Woonzorgcentrum Duneroze
      • Wevelgem, Belgium
        • Woonzorgcentrum Sint-Camillus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wash wipes
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.
Other: Wash wipes (3M)
Other Names:
  • 3M Cavilon Bathing & Cleansing Wipes
  • 3M Cavilon Continence Care Wipes
Placebo Comparator: Standard care
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.
Other: water and pH neutral soap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and category of Incontinence-Associated Dermatitis
Time Frame: within the first 30 days after start of the study
within the first 30 days after start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and category of Pressure Ulcers
Time Frame: within the first 30 days after start of the study
within the first 30 days after start of the study
Comfort and tolerance of the participant
Time Frame: 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.
On baseline, at day 14 and at day 30 (the end of the study)
Comfort and preferences of the caregiver
Time Frame: 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.
On baseline, at day 14 and at day 30 (the end of the study)
adverse effects of the intervention
Time Frame: 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.
within the first 30 days after start of the study
Cost of the experiment (use of wash wipes) versus the standard care
Time Frame: 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
For the duration of the study (30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

3M

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/0277 (OTHER: CEIC)
  • B670201524231 (Other Identifier: Ethics Committee UZ Gent)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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