NCT05403762

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 19, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

May 23, 2022

Results QC Date

February 6, 2026

Last Update Submit

February 24, 2026

Conditions

Incontinence-associated Dermatitis

Keywords

Skin careLong-term careNursing home residentErythemaGeriatric medicine

Outcome Measures

Primary Outcomes (1)

  • Incidence of Incontinence-associated Dermatitis (IAD)

    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 Outcomes (9)

  • Erythema (Instrumental Measurement)

    14 Days

  • Erythema (Visual Inspection)

    14 Days

  • Incidence of Erosion

    14 Days

  • Incidence of Maceration

    14 Days

  • IAD Related Pain

    14 Days

  • +4 more secondary outcomes

Study Arms (3)

ESENTA™ Skin Barrier Spray

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.

Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)

Hydrophobes Basisgel DAC

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.

Other: Hydrophobes Basisgel DAC

Standard Care

NO INTERVENTION

In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.

Interventions

ESENTA™ Skin Barrier Spray (ConvaTec, UK)OTHER

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.

Also known as: Film-forming skin protectant
ESENTA™ Skin Barrier Spray
Hydrophobes Basisgel DACOTHER

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.

Also known as: Hydrophobic skin protectant
Hydrophobes Basisgel DAC

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • El Genedy-Kalyoncu M, Fastner A, Volzer B, Raeder K, Neumann K, Lahmann NA, Kottner J. Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlled pragmatic trial. BMJ Open. 2022 Sep 29;12(9):e065909. doi: 10.1136/bmjopen-2022-065909.

    PMID: 36175092DERIVED

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Dr. Jan Kottner
Organization
Charité - Universitätsmedizin Berlin
jan.kottner@charite.de
+49 30 450 529 412

Study Officials

  • Jan Kottner, Prof.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 3, 2022

Study Start

August 19, 2022

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

March 18, 2026

Results First Posted

March 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Anonymized IPD will be made available beginning 12 months and ending 36 months after publication of trial results.
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.

Locations

DE(1)