Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis

Tan Tock Seng Hospital

Status: Terminated

Conditions: Incontinence-associated Dermatitis

Treatments: Device: Conveen EasiCleanse and Conveen Critic Barrier; Device: Standard cleansing and Conveen Critic Barrier; Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant

Study type: Interventional

Funder types: Other

Identifiers

NCT04625426

SIG18037

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients

Full description

The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients.

To date, there is no conclusive evidence on the "best treatment" for patients presenting with IAD. This has led to current clinical practices tend to select IAD products based on its cost and availability, which can be heavily influenced by marketing and commercialisation efforts.

This study allows investigation of the effectiveness of IAD products to ensure the provision of optimal care.

Enrollment: 86 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 21 years and above at point of recruitment
• Diagnosed with IAD
• At regular risk of exposure to urine and faeces over their hospitalization

Exclusion criteria

• Having a known allergy to the treatment products
• Haemodynamically unstable at point of assessment for study
• Unable to tolerate lateral positioning for skin cleansing and treatment application
• Pregnancy
• Having an existing skin disease at point of study that might lead to inaccurate IAD assessment, such as herpes or scabies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 3 patient groups

3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant

Experimental group

Description:

Skin cleanser: 3M No-Rinse Cleanser. Skin protectant: 3M Cavilon Advanced Skin Protectant (liquid acrylic tetrapolymer skin protectant layer). The skin cleanser was used during every episode of incontinence and the protectant was applied every three days as recommended by the manufacturer.

Treatment:

Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant

Conveen EasiCleanse and Conveen Critic Barrier

Experimental group

Description:

Skin cleanser: Conveen EasiCleanse. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin cleanser was also first used to cleanse the skin, followed by application of the barrier cream, as per the barrier cream manufacturer's instructions.

Treatment:

Device: Conveen EasiCleanse and Conveen Critic Barrier

Soap and water / Incontinence wipes and Conveen Critic Barrier

Active Comparator group

Description:

Skin cleanser: Ordinary soap and water or incontinence wipes. Skin protectant: Conveen Critic Barrier (zinc oxide-based barrier cream). After each episode of incontinence, the skin was cleansed using soap and water or incontinence wipes, followed by application of the barrier cream.

Treatment:

Device: Standard cleansing and Conveen Critic Barrier