Clinical trial NCT05403762: Prevention of Incontinence-associated Dermatitis
Official title: Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incontinence-associated Dermatitis
Keywords: Skin care
Long-term care
Nursing home resident
Erythema
Geriatric medicine
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

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.

Primary outcomes:
measure: Incidence of incontinence-associated dermatitis (IAD)
timeFrame: 14 Days
measure: Erythema (instrumental measurement)
timeFrame: 14 Days
measure: Erythema (visual inspection)
timeFrame: 14 Days
measure: Incidence of erosion
timeFrame: 14 Days
measure: Incidence of maceration
timeFrame: 14 Days
measure: IAD related pain
timeFrame: 14 Days
measure: Patient satisfaction
timeFrame: 14 Days
measure: Incidence of IAD related itch
timeFrame: 14 Days
measure: Presence of local intolerances
timeFrame: 14 Days
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 14 Days
measure: Incidents and serious incidents
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jan Kottner, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.