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

Tan Tock Seng Hospital86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Incontinence-associated Dermatitis

Interventions

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

Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant

Conveen EasiCleanse and Conveen Critic BarrierDEVICE

Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream

Standard cleansing and Conveen Critic BarrierDEVICE

Hospital's standard care for IAD management

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tan Tock Seng Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Number of Participants Who Experienced IAD Healing

Total number of participants who experienced IAD healing

Time frame: Up to seven days from initiation of treatment

Proportion of Participants With IAD Healing

Percentage of participants who experienced IAD healing

Time frame: Up to seven days from initiation of treatment

Secondary Outcomes

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)

Time frame: Up to three days from initiation of treatment

Data from ClinicalTrials.gov

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