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

NCT06978751 | Enrolling By Invitation

• 2 other identifiers: ORU 4.2-02319/20212021-02653
• Study Type: observational
• Target: 1,037
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

Dermatitis; Risk factors; Urinary incontinence; Fecal incontinence; Prognosis

Outcome Measures

Primary Outcomes (1)

• Association between prognostic factors and the development of IAD

  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.

  12 months

Secondary Outcomes (1)

• Incidence of Incontinence-Associated Dermatitis (IAD) in hospitalized incontinent patients

  12 months (during the hospital stay of each enrolled patient, over the 12-month study period)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult hospitalised patients with urinary, faecal, or double incontinence who are free of IAD at inclusion.

You may qualify if:

• The patient or their legally authorized representative signed informed consent.
• The patient is aged 18 years or older.
• The patient suffers from incontinence\* (urinary, faecal, double incontinence).

You may not qualify if:

• Patients admitted to emergency departments, paediatric units, maternity units, psychiatric units, and palliative care units.
• Patients who are receiving end-of-life care.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• University Ghent: collaborator

Study Sites (7)

AZ Sint-Lucas

Ghent, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Sint-Jozefskliniek

Izegem, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

AZ Delta

Rumbeke, Belgium

Location

AZ West

Veurne, Belgium

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (2)

• 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: 37429690 BACKGROUND

• 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.

  PMID: 39016196 BACKGROUND

MeSH Terms

Conditions

Dermatitis; Urinary Incontinence; Fecal Incontinence

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 18, 2025
• Study Start: May 13, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6); SE (1)