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

Incontinence-associated Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04625426
• Other study ID #: SIG18037
• Status: Terminated
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2021
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: September 30, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Incontinence-associated Dermatitis

Intervention

Device:
• 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
• Conveen EasiCleanse and Conveen Critic Barrier
Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
• Standard cleansing and Conveen Critic Barrier
Hospital's standard care for IAD management

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11:CD011627. Review. — View Citation

Beele H, Smet S, Van Damme N, Beeckman D. Incontinence-Associated Dermatitis: Pathogenesis, Contributing Factors, Prevention and Management Options. Drugs Aging. 2018 Jan;35(1):1-10. doi: 10.1007/s40266-017-0507-1. Review. — View Citation

Van Tiggelen H, LeBlanc K, Campbell K, Woo K, Baranoski S, Chang YY, Dunk AM, Gloeckner M, Hevia H, Holloway S, Idensohn P, Karadag A, Koren E, Kottner J, Langemo D, Ousey K, Pokorná A, Romanelli M, Santos VLCG, Smet S, Tariq G, Van den Bussche K, Van Hecke A, Verhaeghe S, Vuagnat H, Williams A, Beeckman D. Standardizing the classification of skin tears: validity and reliability testing of the International Skin Tear Advisory Panel Classification System in 44 countries. Br J Dermatol. 2020 Jul;183(1):146-154. doi: 10.1111/bjd.18604. Epub 2019 Nov 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced IAD Healing	Total number of participants who experienced IAD healing	Up to seven days from initiation of treatment
Primary	Proportion of Participants With IAD Healing	Percentage of participants who experienced IAD healing	Up to seven days from initiation of treatment
Secondary	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