Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06978751
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-12
First Post:
2025-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Risk Assessment Tool for Incontinence-associated Dermatitis (IAD): a Cohort Study on the Predictive Performance of Risk Factors for IAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1037}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between prognostic factors and the development of IAD', 'timeFrame': '12 months', 'description': 'This outcome will assess the relationship between selected prognostic factors (e.g., age, sex, stool consistency, type of incontinence) and the development of incontinence-associated dermatitis (IAD) in hospitalized incontinent patients. IAD status will be assessed using the GLOBIAD (Ghent Global IAD Categorisation Tool). The association between each prognostic factor and IAD will be evaluated using multivariable logistic regression analysis.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Incontinence-Associated Dermatitis (IAD) in hospitalized incontinent patients', 'timeFrame': '12 months (during the hospital stay of each enrolled patient, over the 12-month study period)', 'description': 'The incidence of IAD will be measured as the proportion of hospitalized patients with urinary, fecal, or dual incontinence who develop IAD during their hospital stay. IAD will be assessed using the GLOBIAD (Ghent Global IAD Categorisation Tool).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dermatitis', 'Risk factors', 'Urinary incontinence', 'Fecal incontinence', 'Prognosis'], 'conditions': ['Incontinence Associated Dermatitis']}, 'referencesModule': {'references': [{'pmid': '37429690', 'type': 'BACKGROUND', 'citation': 'Deprez J, Kottner J, Eilegard Wallin A, Ohde N, Baath C, Hommel A, Hultin L, Josefson A, Beeckman D. What are the prognostic factors for the development of incontinence-associated dermatitis (IAD): a protocol for a systematic review and meta-analysis. BMJ Open. 2023 Jul 10;13(7):e073115. doi: 10.1136/bmjopen-2023-073115.'}, {'pmid': '39016196', 'type': 'BACKGROUND', 'citation': 'Deprez J, Ohde N, Eilegard Wallin A, Baath C, Hommel A, Hultin L, Josefson A, Kottner J, Beeckman D. Prognostic factors for the development of incontinence-associated dermatitis (IAD): A systematic review. Int Wound J. 2024 Jul;21(7):e14962. doi: 10.1111/iwj.14962.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The primary goal of this prospective cohort study is to collect data on specific factors, including age, sex, stool consistency, etc. and assess their association with the development of IAD. Through the compilation of this data, the study aims to determine whether the identified factors are indeed risk factors for the occurrence of IAD.\n\nStudy design: Prospective observational cohort study\n\nMethodology:\n\nThis is a multi-center, prospective cohort study in hospitals in Sweden and Belgium. Adult patients (≥18 years) who are incontinent and free of IAD at baseline will be enrolled following informed consent.\n\nData collection: Daily skin assessments of the perineal area will be conducted by trained nurses using the validated Ghent Global Incontinence-Associated Dermatitis Tool (GLOBIAD). If IAD is detected, standardized photographs will be taken for blinded central review by skin integrity experts. Clinical, demographic, and care-related data will be collected, including variables such as age, sex, stool consistency, mobility, hygiene practices, nutrition, medication use, and comorbidities.\n\nThe primary endpoint for this study is to establish an association between the identified factors and the development of IAD in the study population.', 'detailedDescription': 'Problem Statement:\n\nIncontinence-Associated Dermatitis (IAD) is a type of irritant contact dermatitis caused by prolonged skin exposure to urine and/or feces. It commonly affects individuals with incontinence. IAD is associated with decreased quality of life, increased care burden, loss of independence, and higher susceptibility to secondary infections and pressure ulcers. These complications lead to prolonged hospital stays and increased healthcare costs.\n\nDespite its clinical relevance, there is insufficient consensus regarding the most critical risk factors for IAD. Existing literature points to a wide range of potential contributors including patient demographics, comorbidities, hygiene practices, and care protocols. A comprehensive prospective study is needed to investigate these risk factors within a hospitalized population in order to inform effective prevention and management strategies.\n\nMethodology:\n\nA prospective cohort design will be conducted across multiple hospital settings in Sweden and Belgium. The study targets adult patients, aged 18 years or older, who suffer from urinary, fecal, or double incontinence upon admission to the hospital and are free of IAD at enrollment.\n\nThe primary goal of this prospective cohort study is to collect data on specific factors, including age, sex, stool consistency, etc. and assess their association with the development of IAD. Through the compilation of this data, the study aims to determine whether the identified factors are indeed risk factors for the occurrence of IAD.\n\nData Collection:\n\nData collection will be managed through an electronic case report form (eCRF) using the RedCap® platform. Nurses will conduct daily inspections of the perianal skin area for each patient, recording observations and, when signs of IAD were identified, capture photographic evidence. These images will be reviewed by a blinded expert panel from the SCENTR team at Örebro University to confirm the diagnosis.\n\nCollected variables include demographic data such as age, sex, and body weight, as well as clinical and care-related factors. These encompass comorbidities (e.g., diabetes, dermatological conditions, Clostridioides difficile infection), cognitive status, smoking habits, nutritional support (including enteral and parenteral nutrition), sedative and vasopressor use, and antibiotic therapy. Care-related variables include the frequency and type of incontinence, the number of absorbent product changes, skin cleansing and barrier product usage, and whether patients are mechanically ventilated. Additionally, functional assessments based on selected Braden Scale subscales-moisture, friction/shear, self-care ability, and mobility-will be recorded. Stool consistency will be classified using the Bristol Stool Chart, with a particular focus on types 6 and 7 (loose and watery stools), which have been previously identified as potential contributors to skin breakdown.\n\nData Analysis:\n\nStatistical analysis, conducted using SPSS statistical package version 28.0 or later, will involve presenting summary statistics for demographics and clinical characteristics. Univariate analyses will explore associations between potential risk factors and IAD development, employing appropriate tests. Variables with p ≤ 0.2 significance in bivariate analysis will undergo multivariate logistic regression. Beforehand, multicollinearity will be assessed using multiple linear regression, and variables will be removed via the backwards method with P = 0.1 cut-off. Model fit will be evaluated using Nagelkerke R2 and Hosmer-Lemeshow statistic, with significance set at α = 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes adult hospitalised patients with urinary, faecal, or double incontinence who are free of IAD at inclusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient or their legally authorized representative signed informed consent.\n* The patient is aged 18 years or older.\n* The patient suffers from incontinence\\* (urinary, faecal, double incontinence).\n* The patient is free of IAD at inclusion. \\*Incontinence is defined as involuntary loss of urine and/or stool.\n\nExclusion Criteria:\n\n* Patients admitted to emergency departments, paediatric units, maternity units, psychiatric units, and palliative care units.\n* Patients who are receiving end-of-life care.'}, 'identificationModule': {'nctId': 'NCT06978751', 'acronym': 'INCONTECT', 'briefTitle': 'Development of a Risk Assessment Tool for Incontinence-associated Dermatitis (IAD): a Cohort Study on the Predictive Performance of Risk Factors for IAD', 'organization': {'class': 'OTHER', 'fullName': 'Örebro University, Sweden'}, 'officialTitle': 'Development of a Risk Assessment Tool for Incontinence-associated Dermatitis (IAD): a Cohort Study on the Predictive Performance of Risk Factors for IAD', 'orgStudyIdInfo': {'id': 'ORU 4.2-02319/2021'}, 'secondaryIdInfos': [{'id': '2021-02653', 'type': 'OTHER_GRANT', 'domain': 'Swedish Research Council (Vetenskapsrådet)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Izegem', 'country': 'Belgium', 'facility': 'Sint-Jozefskliniek', 'geoPoint': {'lat': 50.91396, 'lon': 3.21378}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Rumbeke', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.93248, 'lon': 3.16716}}, {'city': 'Veurne', 'country': 'Belgium', 'facility': 'AZ West', 'geoPoint': {'lat': 51.07316, 'lon': 2.66803}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Dimitri Beeckman, Professor, PhD, MSc, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Centre for Skin and Wound Research (SCENTR), School of Health Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro University, Sweden', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}