Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence
Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study
1 other identifier
observational
206
1 country
19
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2016
CompletedStudy Start
First participant enrolled
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
December 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedJuly 19, 2017
July 1, 2017
8 months
August 26, 2016
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Acute Physiology and Chronic Health Evaluation score (APACHE II)
1 day
Presence of mechanical ventilation
Up to six days
Presence of dialysis
Up to six days
Presence of infection
Leucocyten count and white blood cell count
Up to six days
Presence of fever
temperature \> 38.0°C
Up to six days
Presence of inadequate arterial oxygen pressure
PaO2 \< 80mmHg
Up to six days
Administration of antibiotics
Up to six days
Administration of steroids
Up to six days
Presence of malnutrition
Measured by serum albumin level
Up to six days
Presence of diabetes
Up to six days
Use of continence products (diapers, underpads)
Up to six days
Use of washing without water (wipes, skin cleansers)
Up to six days
Presence of urinary incontinence
Up to six days
Presence of diarrhea
Measured by Bristol Stool Chart
Up to six days
Presence of Clostridium difficile
Up to six days
Presence of mechanical chafing
Up to six days
Presence of low hemoglobin level
Up to six days
Presence of enteral nutrition
Up to six days
Presence of diminished cognitive awareness
Measured by Glasgow Coma Scale
Up to six days
Study Arms (2)
Cases
Patients with IAD Category 2 (red skin with skin breakdown)
Controls
Patients with IAD Cat. 0 (at risk, no redness and skin intact)
Eligibility Criteria
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).
You may qualify if:
- Being admitted to the intensive care unit
- Being fecal incontinent (=unintentional loss of stool)
You may not qualify if:
- Being \< 18 years
- No contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- 3Mcollaborator
Study Sites (19)
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, 9300, Belgium
ZiekenhuisNetwerk Antwerpen
Antwerp, Belgium
AZ Monica
Deurne, 2100, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Algemeen Ziekenhuis Jan Palfijn
Ghent, 9000, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000, Belgium
AZ Sint-Lucas
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
Jan Yperman Ziekenhuis
Ieper, 8900, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Algemeen Ziekenhuis Groeninge
Kortrijk, 8500, Belgium
Universitaire Ziekenhuizen van de K.U. Leuven
Leuven, 3000, Belgium
Algemeen Ziekenhuis Sint Maarten
Mechelen, 2800, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
Algemeen Ziekenhuis Sint-Augustinus
Veurne, 8630, Belgium
O.L.V. van Lourdesziekenhuis
Waregem, 8790, Belgium
De Gasthuiszusters Antwerpen
Wilrijk, 2610, Belgium
Related Publications (2)
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.
PMID: 27841440BACKGROUNDBeeckman 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.
PMID: 24700170BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitri Beeckman, PhD
University Ghent
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
December 19, 2016
Study Start
October 4, 2016
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
July 19, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share