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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04625426
Other study ID # SIG18037
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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