Clinical trial NCT04625426: Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis
Official title: Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incontinence-associated Dermatitis
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 86
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Experienced IAD Healing
timeFrame: Up to seven days from initiation of treatment
measure: Proportion of Participants With IAD Healing
timeFrame: Up to seven days from initiation of treatment
Secondary outcomes:
measure: Number of Participants Who Developed Skin Loss
timeFrame: Up to three days from initiation of treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Ee Yuee Chan
role: STUDY_DIRECTOR
affiliation: Tan Tock Seng Hospital
name: Cheng Cheng Goh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
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, Pokorna 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.
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.