Prevention of Incontinence-associated Dermatitis

Phase

N/A

Condition

Rash

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Hydrophobes Basisgel DAC

ESENTA™ Skin Barrier Spray (ConvaTec, UK)

Clinical Study ID

NCT05403762

PID

01KG2020

Ages > 65
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Residents/patients at the end of life
Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infectionin the IAD area
Any skin condition or wounds (at investigational areas of the skin) requiringadditional 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 Design

Hydrophobes Basisgel DAC

August 19, 2022

May 31, 2025

Study 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.

Connect with a study center

Charité Universitätsmedizin Berlin
Berlin, 10117
Germany
Active - Recruiting

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