Comparison of two skin protection regimes for the prevention of incontinence-associated dermatitis in geriatric care: an exploratory trial (PID)

Not Applicable

Recruiting

• Conditions: L24; Irritant contact dermatitis

• Registration Number: DRKS00028954
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

(1) Presence of faecal and urinary incontinence.
(2) expected length of stay of at least 14 days
(3) intact skin in the study area or intact skin with first clinical signs of IAD (category 1A)
(4) Written informed consent of the study participant (or legal representative)

Exclusion Criteria

(1) Residents/patients at the end of life
(2) Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area
(3) Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)
(4) Known hypersensitivity or allergy to silicones and/or products to stay at the skin
(5) Topical treatments in the IAD area.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Assessment of IAD on days 0,2,4,6,8,10,12,14 according to GLOBIAD classification (no IAD/IAD 1A/IAD 1B/ IAD 2A/IAD 2B) presented as number of subjects developing an IAD of all subjects (cumulative incidence)