Completed

PIDComparison of Film-forming and Lipophilic Skin Protectants for Prevention of Incontinence-associated Dermatitis in Elderly Care

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Study Aim

This study aims to compare the effectiveness of film-forming and lipophilic skin protectants in preventing Incontinence-associated Dermatitis (IAD) in the elderly, by observing the incidence and severity of IAD according to the Ghent Global IAD Categorisation Tool (GLOBIAD).

What is being tested

ESENTA™ Skin Barrier Spray (ConvaTec, UK)

+ Hydrophobes Basisgel DAC

Other
Who is being recruted

Erythema+3

+ Signs and Symptoms

+ Skin Diseases

Over 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorCharite University, Berlin, Germany
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 19, 2022

Actual date on which the first participant was enrolled.

This study focuses on a skin condition called incontinence-associated dermatitis (IAD). IAD is a skin inflammation caused by prolonged contact with urine and/or stool, commonly affecting elderly and care-dependent individuals who experience incontinence. The goal of this research is to compare the effectiveness of two different skin protection products in preventing IAD, as currently, there's no clear evidence favoring one product over another. The study involves elderly nursing home residents and geriatric patients in Berlin, Germany, who are over 65 years old and experience urinary and fecal incontinence, but do not show severe IAD symptoms. The importance of this study lies in its potential to improve skin care routines and prevent IAD in the elderly population. During the 14-day study, participants are randomly divided into two groups. Each group receives a different skin protection product, either film-forming or lipophilic, in addition to their standard skin care routine. Every other day, investigators examine the skin and measure redness using special instruments. They also assess any IAD-related pain and itching. The primary outcome of the study is to determine the number of participants who develop IAD. The severity of IAD is classified using the Ghent Global IAD Categorisation Tool (GLOBIAD), which ranges from persistent redness without infection to skin loss with infection.

Official TitleComparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)
NCT05403762
Principal SponsorCharite University, Berlin, Germany
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ErythemaSigns and SymptomsSkin DiseasesSkin ManifestationsPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
Geriatric patients or residents being incontinent of urine and stool

Expected minimum length of stay of 14 days at the care facility

Intact skin with no clinical signs of IAD OR

intact skin with early clinical signs of IAD (IAD category 1A)

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5 exclusion criteria prevent from participating
Residents/patients at the end of life

Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area

Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)

Known hypersensitivity or allergy to silicones and/or topical leave-on products

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In the intervention group I, standardized mild skin cleansing regimen and daily topical application of a film-forming skin protectant at the exposed skin areas will be applied by nursing staff.

Group II

Experimental
In the intervention group II, standardized mild skin cleansing regimen and daily topical application of a hydrophobic skin protectant at the exposed skin areas will be applied by nursing staff.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Charité Universitätsmedizin Berlin

Berlin, GermanyOpen Charité Universitätsmedizin Berlin in Google Maps
CompletedOne Study Center