Development of a Risk Assessment Tool for Incontinence-associated Dermatitis (IAD): a Cohort Study on the Predictive Performance of Risk Factors for IAD

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. Study design: Prospective observational cohort study Methodology: This 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. Data 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. The primary endpoint for this study is to establish an association between the identified factors and the development of IAD in the study population.

NCT Number	NCT06978751
Lead Sponsor	Örebro University, Sweden Collaborators: University Ghent
Conditions	Incontinence Associated Dermatitis
Enrollment	271 participants
Start Date	2025-05-13
Primary Completion	2026-05-18 (estimated)
Study Completion	2026-05-18 (estimated)
Updated on ClinicalTrials.gov	2026-05-22