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

NCT06978751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 271

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Incontinence Associated Dermatitis

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • Örebro University, Sweden

    lead OTHER

Principal Investigators

  • Dimitri Beeckman, Professor, PhD, MSc, RN · Swedish Centre for Skin and Wound Research (SCENTR), School of Health Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2026-05-18
Completion
2026-05-18

Countries

  • Belgium
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978751 on ClinicalTrials.gov