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

Primary Purpose

Irritant Contact Dermatitis Due to Incontinence, Diaper Rash, Pressure Ulcer

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Wash wipes (3M)
water and pH neutral soap
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Irritant Contact Dermatitis Due to Incontinence focused on measuring elderly, long-term care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Woonzorgcentrum Sint-Jozef
  • Woonzorgcentrum Ceder aan de Leie
  • Woonzorgcentrum Heilig Hart
  • Woonzorgcentrum Sint-Jozef
  • Woonzorgcentrum De Samaritaan
  • Woonzorgcentrum de Boarebreker
  • Woonzorgcentrum De Kroon
  • Woonzorgcentrum Deken Darras
  • Woonzorgcentrum Onze Lieve Vrouw van Lourdes
  • Woonzorgcentrum Duneroze
  • Woonzorgcentrum Sint-Camillus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wash wipes

Standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence and category of Incontinence-Associated Dermatitis

Secondary Outcome Measures

Incidence and category of Pressure Ulcers
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.
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.
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.
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

Full Information

First Posted
May 21, 2015
Last Updated
February 8, 2016
Sponsor
University Ghent
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT02475512
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Ghent
Collaborators
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritant Contact Dermatitis Due to Incontinence, Diaper Rash, Pressure Ulcer, Incontinence-associated Dermatitis
Keywords
elderly, long-term care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wash wipes
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Wash wipes (3M)
Other Intervention Name(s)
3M Cavilon Bathing & Cleansing Wipes, 3M Cavilon Continence Care Wipes
Intervention Type
Other
Intervention Name(s)
water and pH neutral soap
Primary Outcome Measure Information:
Title
Incidence and category of Incontinence-Associated Dermatitis
Time Frame
within the first 30 days after start of the study
Secondary Outcome Measure Information:
Title
Incidence and category of Pressure Ulcers
Time Frame
within the first 30 days after start of the study
Title
Comfort and tolerance of the participant
Description
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.
Time Frame
On baseline, at day 14 and at day 30 (the end of the study)
Title
Comfort and preferences of the caregiver
Description
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.
Time Frame
On baseline, at day 14 and at day 30 (the end of the study)
Title
adverse effects of the intervention
Description
Adverse effects such as skin irritation, rash, itching, treatment related pain, skin dryness related to the interventions under study will be monitored.
Time Frame
within the first 30 days after start of the study
Title
Cost of the experiment (use of wash wipes) versus the standard care
Description
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
Time Frame
For the duration of the study (30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Beeckman, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woonzorgcentrum Sint-Jozef
City
Brugge
Country
Belgium
Facility Name
Woonzorgcentrum Ceder aan de Leie
City
Harelbeke
Country
Belgium
Facility Name
Woonzorgcentrum Heilig Hart
City
Kortrijk
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Jozef
City
Kortrijk
Country
Belgium
Facility Name
Woonzorgcentrum De Samaritaan
City
Nukerke
ZIP/Postal Code
9681
Country
Belgium
Facility Name
Woonzorgcentrum de Boarebreker
City
Oostende
Country
Belgium
Facility Name
Woonzorgcentrum De Kroon
City
Sint-Gillis-Waas
Country
Belgium
Facility Name
Woonzorgcentrum Deken Darras
City
Tielt
Country
Belgium
Facility Name
Woonzorgcentrum Onze Lieve Vrouw van Lourdes
City
Wakken
Country
Belgium
Facility Name
Woonzorgcentrum Duneroze
City
Wenduine
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Camillus
City
Wevelgem
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24700170
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.
Results Reference
background
Links:
URL
http://www.ucvvgent.be
Description
Website of the research group

Learn more about this trial

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

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