Irritant Contact Dermatitis Due to IncontinenceNCT02475512
Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly
A study testing Wash wipes (3M) and water and pH neutral soap in people with Irritant Contact Dermatitis Due to Incontinence and Diaper Rash, run by University Ghent at 11 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritant Contact Dermatitis Due to Incontinence, Diaper Rash, Pressure Ulcer
- What is being tested?
- Wash wipes (3M) and water and pH neutral soap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 11 sitesBelgium
- Study dates
- May 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
Woonzorgcentrum Sint-Jozef
Bruges
Woonzorgcentrum Ceder aan de Leie
Harelbeke
Woonzorgcentrum Heilig Hart
Kortrijk
Woonzorgcentrum Sint-Jozef
Kortrijk
Woonzorgcentrum De Samaritaan
Nukerke, 9681
Woonzorgcentrum de Boarebreker
Ostend
Woonzorgcentrum De Kroon
Sint-Gillis-Waas
Woonzorgcentrum Deken Darras
Tielt
Woonzorgcentrum Onze Lieve Vrouw van Lourdes
Wakken
Woonzorgcentrum Duneroze
Wenduine
Woonzorgcentrum Sint-Camillus
Wevelgem
About this study
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
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.
- Conditions
- Irritant Contact Dermatitis Due to Incontinence, Diaper Rash, Pressure Ulcer, Incontinence-associated Dermatitis
- Being tested
- Wash wipes (3M), water and pH neutral soap
- Keywords
- elderly, long-term care
- Medical subject headings
- Diaper Rash, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wash wipes (3M)Other
Also called 3M Cavilon Bathing & Cleansing Wipes, 3M Cavilon Continence Care Wipes
water and pH neutral soapOther
| Study group | Role | What they receive |
|---|---|---|
| Wash wipes | Experimental | 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. Receives: Other: Wash wipes (3M) |
| Standard care | Placebo comparator | 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. Receives: Other: water and pH neutral soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and category of Incontinence-Associated Dermatitis
Measured: within the first 30 days after start of the study
Secondary outcomes (5)
Incidence and category of Pressure Ulcers
Measured: within the first 30 days after start of the study
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.
Measured: On baseline, at day 14 and at day 30 (the end of the study)
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.
Measured: On baseline, at day 14 and at day 30 (the end of the study)
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.
Measured: within the first 30 days after start of the study
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
Measured: For the duration of the study (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritant Contact Dermatitis Due to IncontinenceStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, UCVV, University Ghent
- Investigators
- Dimitri Beeckman, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475512
- Sponsor's protocol ID
- 2015/0277
- Other IDs
- B670201524231
- Status last verified
- Feb 2016
- First submitted
- 21 May 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24700170
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02475512
- Acronym / sponsor ID
- 2015/0277
- Conditions
- Irritant Contact Dermatitis Due to Incontinence, Diaper Rash, Pressure Ulcer, Incontinence-associated Dermatitis
- Keywords
- elderly, long-term care
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- 3M
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wash wipes | Experimental | Other: 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 | Placebo comparator | Other: water and pH neutral soapWashing will be done using water and pH neutral soap. No other preventive barrier or hydration products will be allowed in the genital-anal region. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wash wipes (3M)Also: 3M Cavilon Bathing & Cleansing Wipes, 3M Cavilon Continence Care Wipes | Other | Wash wipes |
| water and pH neutral soap | Other | Standard care |
Primary outcome
Incidence and category of Incontinence-Associated Dermatitis
Time frame: within the first 30 days after start of the study
5 secondary outcomes
Incidence and category of Pressure Ulcers
Time frame: 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)
Comfort and preferences of the caregiver
Time frame: 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
Cost of the experiment (use of wash wipes) versus the standard care
Time frame: For the duration of the study (30 days)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Background: PubMed 24700170Beeckman 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.
- Website of the research groupLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Beeckman, PhD principal investigator
University Ghent
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wash wipes (3M) and water and pH neutral soap in people with Irritant Contact Dermatitis Due to Incontinence and Diaper Rash, run by University Ghent at 11 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and category of Incontinence-Associated Dermatitis (time frame: within the first 30 days after start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.