Prevention of Incontinence-associated Dermatitis

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · May 31, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating ways to prevent a skin condition called incontinence-associated dermatitis (IAD), which is inflammation of the skin caused by contact with urine and stool. This condition often affects elderly people, especially those living in care facilities. The study will compare two different skin protection products to see how effective they are at preventing IAD, and it will also include a group that does not receive any treatment for comparison.

To participate in the trial, individuals must be elderly patients or nursing home residents who are incontinent of urine and stool, and they should have intact skin or only early signs of IAD. Participants need to be expected to stay in the care facility for at least 14 days and must give written consent to join. Those who are nearing the end of life, have more severe IAD, or have other skin issues will not be eligible. If someone joins the study, they will help researchers learn more about which skin protection products work best to keep the skin healthy and prevent IAD.

Gender

ALL

Eligibility 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.