Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 3M | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients with IAD Category 2 (red skin with skin breakdown) | ||
| Controls | Patients with IAD Cat. 0 (at risk, no redness and skin intact) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitri Beeckman, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| ZiekenhuisNetwerk Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27841440 | Background | 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. | |
| 24700170 |
| Label | URL |
|---|---|
| Website of the research group | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003963 | Diaper Rash |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
Not provided
Not provided