Prevention of Incontinence-associated Dermatitis (PID)

February 24, 2026 updated by: Prof. Dr. Jan Kottner, Charite University, Berlin, Germany

Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)

Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged and direct contact of the skin with urine and/or stool. It may occur in all age groups but elderly and care-dependent incontinent people are often affected by this type of inflammation. Promotion of continence, use of absorbent products and structured skin care are recommended to prevent and/or treat IAD. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. Currently, there is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory randomized controlled trial in incontinent elderly nursing home residents and geriatric patients will be conducted. In the two intervention groups, a film-forming or a lipophilic skin protection product will be applied in addition to standardized skin care regimens. Every other day, investigators will perform skin inspections, including instrumental skin measurements to quantify erythema for a total study period of n= 14 days. IAD- related pain and itch will be assessed. A total of n= 210 nursing home residents and geriatric patients in Berlin, Germany, aged over 65 years, who are affected by urinary and faecal incontinence without signs of severe IAD will be included.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)
  • Written informed consent

Exclusion Criteria:

  • 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
  • Topical treatments in the IAD area.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESENTA™ Skin Barrier Spray
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.
Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)
The skin protectant will be applied on clean and dry skin exposed to urine and stool. After application, the solvent evaporates leaving a silicone film on the skin surface.
Other Names:
  • Film-forming skin protectant
Experimental: Hydrophobes Basisgel DAC
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.
Other: Hydrophobes Basisgel DAC
The skin protectant will be applied on clean and dry skin. It contains 95% paraffin oil and creates a hydrophobic layer on the skin surface.
Other Names:
  • Hydrophobic skin protectant
No Intervention: Standard Care
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Incontinence-associated Dermatitis (IAD)
Time Frame: 14 Days

Number of subjects developing IAD of all subjects (cumulative incidence).

Classification of IAD according to Ghent Global IAD Categorisation Tool (GLOBIAD) (Category 1A, 1B, 2A, 2B). The GLOBIAD categorises IAD severity based on visual inspection of the affected skin areas.

Category 1A: Persistent redness without clinical signs of infection Category 1B: Persistent redness with clinical signs of infection Category 2A: Skin loss without clinical signs of infection Category 2B: Skin loss with clinical signs of infection
14 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 14 Days
AEs and SAEs will be documented and reported according to the current regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) Article 2.
14 Days
Erythema (Instrumental Measurement)
Time Frame: 14 Days
Erythema measured with the Mexameter MX® 18 (Courage + Khazaka, Cologne, Germany). Means of two duplicate measurements per skin area are displayed in arbitrary units (AU) ranging from 0 (= no erythema) to 999 (= extreme erythema).
14 Days
Erythema (Visual Inspection)
Time Frame: 14 Days
Clinical rating of erythema is conducted according to the item 'Redness' of the incontinence-associated dermatitis and its severity (IADS) instrument. The 3-Item-Scale describes 'Redness' as (1) none, (2) pink, (3) red/ bright red.
14 Days
Incidence of Erosion
Time Frame: 14 Days
The presence (no or yes) of erosion is defined according to the latest International League of Dermatological Societies glossary of cutaneous lesions as a loss of either a portion of or the entire epidermis. Number of subjects developing erosions of all subjects (cumulative incidence).
14 Days
Incidence of Maceration
Time Frame: 14 Days
The presence (no or yes) of maceration is defined as the result of prolonged exposure (of the skin) to moisture and causes the skin to soften and breakdown so that the connective fibres can be teased apart and the skin often exhibits a white appearance. Number of subjects developing maceration of all subjects (cumulative incidence).
14 Days
IAD Related Pain
Time Frame: 14 Days
Numeric Rating Scale (NRS) pain score. The NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity. The NRS was administered only to participants without cognitive impairment (MMSE ≥24).
14 Days
Incidence of IAD Related Itch
Time Frame: 14 Days
IAD related itch will be reported directly by patients (yes or no). Number of subjects reporting itch of all subjects (cumulative incidence).
14 Days
Presence of Local Intolerances
Time Frame: 14 Days

The presence of local intolerances will be assessed with the following options:

(0) None;

  1. homogeneous redness with scattered papules;
  2. homogeneous redness and homogeneous infiltration
  3. homogeneous redness and infiltration with vesicles
  4. homogeneous redness and infiltration with coalescing vesicles
14 Days
Incidents and Serious Incidents
Time Frame: 14 Days
Incidents abd serious incidents will be documented according to the definition of the EU regulation 2017/745 MDR Article 2 and reported to the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Jan Kottner, Prof., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2022

Primary Completion (Actual)

February 6, 2025

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID
  • 01KG2020 (Other Grant/Funding Number: German Federal Ministry of Education and Research (BMBF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol will be shared as part of this trial registration.

IPD Sharing Time Frame

Anonymized IPD will be made available beginning 12 months and ending 36 months after publication of trial results.

IPD Sharing Access Criteria

IPD will be shared with researchers who submit a methodologically sound proposal. The proposal must clearly state the research objectives and the intended methods of analysis. It is planned to share the data with restricted access via zenodo.org.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incontinence-associated Dermatitis

Clinical Trials on ESENTA™ Skin Barrier Spray (ConvaTec, UK)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe