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

Not Applicable

Terminated

• Conditions: Incontinence-associated Dermatitis

• 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.

Study Timeline

• Study Start: 2019-04-29
• Primary Completion: 2020-01-20
• Study Completion: 2020-09-30
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-12
• Results First Submitted: 2021-03-15
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Results First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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