Irritant Contact DermatitisNCT02996357
Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence
An observational study of Irritant Contact Dermatitis and Diaper Rash, run by University Ghent at 19 sites in Belgium.
Trial summary
This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence). 380 ICU patients suffering of fecal incontinence will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritant Contact Dermatitis, Diaper Rash, Incontinence-associated Dermatitis
- How many people
- 206 participants
- Where
- 19 sitesBelgium
- Study dates
- 4 Oct 2016to 31 May 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to intensive care unit, with fecal incontinence (a known risk for IAD Cat. 2 development) will be sampled. The presence of fecal incontinence (any type) will be used as the only variable for matching (as not to reduce the possibility to interfere with associated risk factors).
Who may be able to join
- Being admitted to the intensive care unit
- Being fecal incontinent (=unintentional loss of stool)
Who cannot join
- Being < 18 years
- No contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Belgium19 sites
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, 9300
ZiekenhuisNetwerk Antwerpen
Antwerp
AZ Monica
Deurne, 2100
Ziekenhuis Oost-Limburg
Genk, 3600
Algemeen Ziekenhuis Jan Palfijn
Ghent, 9000
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000
AZ Sint-Lucas
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
Jessa Ziekenhuis
Hasselt, 3500
Jan Yperman Ziekenhuis
Ieper, 8900
Universitair Ziekenhuis Brussel
Jette, 1090
Algemeen Ziekenhuis Groeninge
Kortrijk, 8500
Universitaire Ziekenhuizen van de K.U. Leuven
Leuven, 3000
Algemeen Ziekenhuis Sint Maarten
Mechelen, 2800
Algemeen Ziekenhuis Delta
Roeselare, 8800
AZ Nikolaas
Sint-Niklaas, 9100
Algemeen Ziekenhuis Sint-Augustinus
Veurne, 8630
O.L.V. van Lourdesziekenhuis
Waregem, 8790
De Gasthuiszusters Antwerpen
Wilrijk, 2610
About this study
Official title: Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study
This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).
380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19 possible risk factors will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.
Read the detailed description
Incontinence is a widespread problem in all health care settings. Prevalence figures of incontinence vary around 20.0% of all hospitalized patients. In acute and critical care units the proportion of patients with fecal incontinence may rise up to 33.0%.
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 defined as skin inflammation manifested as redness with or without blistering, erosion, or loss of skin barrier function that occurs as a consequence of chronically or repeated exposure of the skin to urine or faeces.
A range of skin care products and procedures for the prevention of IAD exists. In order to provide cost-effective IAD prevention, it's important to target preventive skin care interventions to patients at risk of IAD.
The aims of this study are:
- To identify specific factors associated with the development of Incontinence- Associated Dermatitis (IAD) in a recognized high risk patient population (ICU patients suffering from fecal incontinence)
- To develop and statistically validate patient profiles being associated with high risk for IAD development
This study is a matched case control study. The cases are defined as patients with IAD Cat. 2 (red skin with skin breakdown). The controls are defined as patients with IAD Cat. 0 (at risk, no redness and skin intact). The patient will be matched for fecal incontinence.
In total, 380 ICU patients suffering from fecal incontinence will be included. 19 possible risk factors will be studied.
All data will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.
Specific IAD risk factors will be determined by applying univariate and multivariate binary logistic regression modeling.
- Keywords
- Incontinence-associated dermatitis, Risk factor, Intensive care unit, Prevention
- Medical subject headings
- Dermatitis, Irritant, Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with IAD Category 2 (red skin with skin breakdown) | |
| Controls | Patients with IAD Cat. 0 (at risk, no redness and skin intact) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Physiology and Chronic Health Evaluation score (APACHE II)
Measured: 1 day
Presence of mechanical ventilation
Measured: Up to six days
Presence of dialysis
Measured: Up to six days
Presence of infection
Leucocyten count and white blood cell count
Measured: Up to six days
Presence of fever
temperature > 38.0°C
Measured: Up to six days
Presence of inadequate arterial oxygen pressure
PaO2 < 80mmHg
Measured: Up to six days
Administration of antibiotics
Measured: Up to six days
Administration of steroids
Measured: Up to six days
Presence of malnutrition
Measured by serum albumin level
Measured: Up to six days
Presence of diabetes
Measured: Up to six days
Use of continence products (diapers, underpads)
Measured: Up to six days
Use of washing without water (wipes, skin cleansers)
Measured: Up to six days
Presence of urinary incontinence
Measured: Up to six days
Presence of diarrhea
Measured by Bristol Stool Chart
Measured: Up to six days
Presence of Clostridium difficile
Measured: Up to six days
Presence of mechanical chafing
Measured: Up to six days
Presence of low hemoglobin level
Measured: Up to six days
Presence of enteral nutrition
Measured: Up to six days
Presence of diminished cognitive awareness
Measured by Glasgow Coma Scale
Measured: Up to six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start4 Oct 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritant Contact DermatitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996357
- Sponsor's protocol ID
- 2016/0883
- Status last verified
- Jul 2017
- First submitted
- 26 Aug 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
PubMed 27841440Beeckman 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 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study
- ClinicalTrials.gov ID
- NCT02996357
- Acronym / sponsor ID
- 2016/0883
- Keywords
- Incontinence-associated dermatitis, Risk factor, Intensive care unit, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 19 Dec 2016 (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.
This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).
380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19 possible risk factors will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.
Detailed description
Incontinence is a widespread problem in all health care settings. Prevalence figures of incontinence vary around 20.0% of all hospitalized patients. In acute and critical care units the proportion of patients with fecal incontinence may rise up to 33.0%.
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 defined as skin inflammation manifested as redness with or without blistering, erosion, or loss of skin barrier function that occurs as a consequence of chronically or repeated exposure of the skin to urine or faeces.
A range of skin care products and procedures for the prevention of IAD exists. In order to provide cost-effective IAD prevention, it's important to target preventive skin care interventions to patients at risk of IAD.
The aims of this study are:
- To identify specific factors associated with the development of Incontinence- Associated Dermatitis (IAD) in a recognized high risk patient population (ICU patients suffering from fecal incontinence)
- To develop and statistically validate patient profiles being associated with high risk for IAD development
This study is a matched case control study. The cases are defined as patients with IAD Cat. 2 (red skin with skin breakdown). The controls are defined as patients with IAD Cat. 0 (at risk, no redness and skin intact). The patient will be matched for fecal incontinence.
In total, 380 ICU patients suffering from fecal incontinence will be included. 19 possible risk factors will be studied.
All data will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.
Specific IAD risk factors will be determined by applying univariate and multivariate binary logistic regression modeling.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with IAD Category 2 (red skin with skin breakdown) |
| Controls | – | –Patients with IAD Cat. 0 (at risk, no redness and skin intact) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care unit, with fecal incontinence (a known risk for IAD Cat. 2 development) will be sampled. The presence of fecal incontinence (any type) will be used as the only variable for matching (as not to reduce the possibility to interfere with associated risk factors).
Key inclusion criteria (2 listed)
- Being admitted to the intensive care unit
- Being fecal incontinent (=unintentional loss of stool)
Key exclusion criteria (2 listed)
- Being < 18 years
- No contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Physiology and Chronic Health Evaluation score (APACHE II)
Time frame: 1 day
Presence of mechanical ventilation
Time frame: Up to six days
Presence of dialysis
Time frame: Up to six days
Presence of infection
Time frame: Up to six days
Leucocyten count and white blood cell count
Presence of fever
Time frame: Up to six days
temperature > 38.0°C
Presence of inadequate arterial oxygen pressure
Time frame: Up to six days
PaO2 < 80mmHg
Administration of antibiotics
Time frame: Up to six days
Administration of steroids
Time frame: Up to six days
Presence of malnutrition
Time frame: Up to six days
Measured by serum albumin level
Presence of diabetes
Time frame: Up to six days
Use of continence products (diapers, underpads)
Time frame: Up to six days
Use of washing without water (wipes, skin cleansers)
Time frame: Up to six days
Presence of urinary incontinence
Time frame: Up to six days
Presence of diarrhea
Time frame: Up to six days
Measured by Bristol Stool Chart
Presence of Clostridium difficile
Time frame: Up to six days
Presence of mechanical chafing
Time frame: Up to six days
Presence of low hemoglobin level
Time frame: Up to six days
Presence of enteral nutrition
Time frame: Up to six days
Presence of diminished cognitive awareness
Time frame: Up to six days
Measured by Glasgow Coma Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 27841440Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
- 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.
- Individual participant dataSharing planned: No
Related trials for Irritant Contact Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Recruiting
Helichrysum Italicum Extract in Irritant Contact Dermatitis
Skin Barrier Disruption and Recovery
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
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
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritant Contact Dermatitis and Diaper Rash, run by University Ghent at 19 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute Physiology and Chronic Health Evaluation score (APACHE II) (time frame: 1 day). The study lists 19 primary outcomes in all. 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 NCT02996357, which also lists 2 linked publications.
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 19 Jul 2017.