Comparing skin protection products for preventing incontinence-associated dermatitis
Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)
This study tests whether two different skin protection products can help prevent skin problems caused by incontinence in elderly nursing home residents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05403762 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two different skin protection products in preventing incontinence-associated dermatitis (IAD) among elderly nursing home residents and geriatric patients. Participants will be randomly assigned to receive either a film-forming or a lipophilic skin protectant, in addition to standardized skin care regimens, while a control group will receive no treatment. Over a 14-day period, skin inspections and measurements will be conducted to assess the severity of erythema and any associated pain or itch. The study will include a total of 210 participants aged over 65 years who are incontinent but do not have severe IAD.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly nursing home residents or geriatric patients aged over 65 who are incontinent of urine and stool but have intact skin or early signs of IAD.
Not a fit: Patients with severe IAD or other significant skin conditions requiring treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved skin care protocols that significantly reduce the incidence of incontinence-associated dermatitis in elderly patients.
How similar studies have performed: While there is limited evidence on the superiority of specific skin protection products for IAD, this study's comparative approach is novel and aims to fill a gap in existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Berlin
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Jan Kottner, Prof. — Charite University, Berlin, Germany
- Study coordinator: Jan Kottner, Prof.
- Email: jan.kottner@charite.de
- Phone: 0049 30 450 529411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.