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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study

Conditions
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Incontinence-associated Dermatitis

Intervention / Treatment
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* Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
* Device: Conveen EasiCleanse and Conveen Critic Barrier
* Device: Standard cleansing and Conveen Critic Barrier


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomised trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant<br>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. | Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant<br>* Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant<br>|
| Experimental: Conveen EasiCleanse and Conveen Critic Barrier<br>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. | Device: Conveen EasiCleanse and Conveen Critic Barrier<br>* Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream<br>|
| Active Comparator: Soap and water / Incontinence wipes and Conveen Critic Barrier<br>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. | Device: Standard cleansing and Conveen Critic Barrier<br>* Hospital's standard care for IAD management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced IAD Healing | Total number of participants who experienced IAD healing | Up to seven days from initiation of treatment | 
| Proportion of Participants With IAD Healing | Percentage of participants who experienced IAD healing | Up to seven days from initiation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Developed Skin Loss | Examination of the development of skin loss using the Ghent Global IAD Categorisation tool (GLOBIAD). Binary scoring, 1 and 2. Higher value (2) indicates worse outcome (Development of skin loss) | Up to three days from initiation of treatment |