Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 6:21 PM
Study NCT ID:
NCT02996357
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017453', 'term': 'Dermatitis, Irritant'}, {'id': 'D003963', 'term': 'Diaper Rash'}], 'ancestors': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Physiology and Chronic Health Evaluation score (APACHE II)', 'timeFrame': '1 day'}, {'measure': 'Presence of mechanical ventilation', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of dialysis', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of infection', 'timeFrame': 'Up to six days', 'description': 'Leucocyten count and white blood cell count'}, {'measure': 'Presence of fever', 'timeFrame': 'Up to six days', 'description': 'temperature \\> 38.0°C'}, {'measure': 'Presence of inadequate arterial oxygen pressure', 'timeFrame': 'Up to six days', 'description': 'PaO2 \\< 80mmHg'}, {'measure': 'Administration of antibiotics', 'timeFrame': 'Up to six days'}, {'measure': 'Administration of steroids', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of malnutrition', 'timeFrame': 'Up to six days', 'description': 'Measured by serum albumin level'}, {'measure': 'Presence of diabetes', 'timeFrame': 'Up to six days'}, {'measure': 'Use of continence products (diapers, underpads)', 'timeFrame': 'Up to six days'}, {'measure': 'Use of washing without water (wipes, skin cleansers)', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of urinary incontinence', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of diarrhea', 'timeFrame': 'Up to six days', 'description': 'Measured by Bristol Stool Chart'}, {'measure': 'Presence of Clostridium difficile', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of mechanical chafing', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of low hemoglobin level', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of enteral nutrition', 'timeFrame': 'Up to six days'}, {'measure': 'Presence of diminished cognitive awareness', 'timeFrame': 'Up to six days', 'description': 'Measured by Glasgow Coma Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incontinence-associated dermatitis', 'Risk factor', 'Intensive care unit', 'Prevention'], 'conditions': ['Irritant Contact Dermatitis', 'Diaper Rash', 'Incontinence-associated Dermatitis']}, 'referencesModule': {'references': [{'pmid': '27841440', 'type': 'BACKGROUND', 'citation': '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': '24700170', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.ucvvgent.be', 'label': 'Website of the research group'}]}, 'descriptionModule': {'briefSummary': 'This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).\n\n380 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.', 'detailedDescription': "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%.\n\nOne 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.\n\nA 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.\n\nThe aims of this study are:\n\n1. 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)\n2. To develop and statistically validate patient profiles being associated with high risk for IAD development\n\nThis 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.\n\nIn total, 380 ICU patients suffering from fecal incontinence will be included. 19 possible risk factors will be studied.\n\nAll 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.\n\nSpecific IAD risk factors will be determined by applying univariate and multivariate binary logistic regression modeling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being admitted to the intensive care unit\n* Being fecal incontinent (=unintentional loss of stool)\n\nExclusion Criteria:\n\n* Being \\< 18 years\n* No contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)'}, 'identificationModule': {'nctId': 'NCT02996357', 'briefTitle': 'Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study', 'orgStudyIdInfo': {'id': '2016/0883'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with IAD Category 2 (red skin with skin breakdown)'}, {'label': 'Controls', 'description': 'Patients with IAD Cat. 0 (at risk, no redness and skin intact)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze-Lieve-Vrouwziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZiekenhuisNetwerk Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2100', 'city': 'Deurne', 'country': 'Belgium', 'facility': 'AZ Monica', 'geoPoint': {'lat': 51.22134, 'lon': 4.46595}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Jan Palfijn', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '8900', 'city': 'Ieper', 'country': 'Belgium', 'facility': 'Jan Yperman Ziekenhuis', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen van de K.U. Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2800', 'city': 'Mechelen', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint Maarten', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'AZ Nikolaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '8630', 'city': 'Veurne', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Augustinus', 'geoPoint': {'lat': 51.07316, 'lon': 2.66803}}, {'zip': '8790', 'city': 'Waregem', 'country': 'Belgium', 'facility': 'O.L.V. van Lourdesziekenhuis', 'geoPoint': {'lat': 50.88898, 'lon': 3.42756}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'De Gasthuiszusters Antwerpen', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}], 'overallOfficials': [{'name': 'Dimitri Beeckman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}