Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis
- Conditions
- Incontinence-associated Dermatitis
- Interventions
- Device: Conveen EasiCleanse and Conveen Critic BarrierDevice: Standard cleansing and Conveen Critic BarrierDevice: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
- Registration Number
- NCT04625426
- Lead Sponsor
- Tan Tock Seng Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 86
- Aged 21 years and above at point of recruitment
- Diagnosed with IAD
- At regular risk of exposure to urine and faeces over their hospitalization
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conveen EasiCleanse and Conveen Critic Barrier Conveen EasiCleanse and Conveen Critic Barrier 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. Soap and water / Incontinence wipes and Conveen Critic Barrier Standard cleansing and Conveen Critic Barrier 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. 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant 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.
- Primary Outcome Measures
Name Time Method Proportion of Participants With IAD Healing Up to seven days from initiation of treatment Percentage of participants who experienced IAD healing
Number of Participants Who Experienced IAD Healing Up to seven days from initiation of treatment Total number of participants who experienced IAD healing
- Secondary Outcome Measures
Name Time Method Number of Participants Who Developed Skin Loss Up to three days from initiation of treatment 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)
Trial Locations
- Locations (1)
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital🇸🇬Singapore, Singapore