Prevention of Incontinence-associated Dermatitis (PID)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Incontinence-associated Dermatitis

Treatments: Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK); Other: Hydrophobes Basisgel DAC

Study type: Interventional

Funder types: Other

Identifiers

NCT05403762

01KG2020 (Other Grant/Funding Number)

PID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 3 patient groups

ESENTA™ Skin Barrier Spray

Experimental group

Description:

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.

Treatment:

Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)

Hydrophobes Basisgel DAC

Experimental group

Description:

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.

Treatment:

Other: Hydrophobes Basisgel DAC

Standard Care

No Intervention group

Description:

In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.