Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
210 participants
INTERVENTIONAL
2022-08-19
2025-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence
NCT02996357
Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
NCT03298113
Comparison of Barrier Products in the Prevention of Incontinence-associated Dermatitis in Hospitalized Elderly
NCT03309059
Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis
NCT04625426
How Wet Pads Affect Elderly Skin: Measuring Changes in the Skin Barrier
NCT07164898
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Standard Care
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Jan Kottner
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Kottner, Prof.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Charité Universitätsmedizin Berlin
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01KG2020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PID
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.