Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis
NCT ID: NCT04625426
Last Updated: 2021-05-05
Study Results
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View full resultsBasic Information
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TERMINATED
NA
86 participants
INTERVENTIONAL
2019-04-29
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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3M No-Rinse 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.
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
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.
Conveen EasiCleanse and Conveen Critic Barrier
Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
Soap and water / Incontinence wipes 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.
Standard cleansing and Conveen Critic Barrier
Hospital's standard care for IAD management
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with IAD
* At regular risk of exposure to urine and faeces over their hospitalization
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Tan Tock Seng Hospital
OTHER
Responsible Party
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Principal Investigators
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Ee Yuee Chan
Role: STUDY_DIRECTOR
Tan Tock Seng Hospital
Cheng Cheng Goh
Role: PRINCIPAL_INVESTIGATOR
Tan Tock Seng Hospital
Locations
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Tan Tock Seng Hospital
Singapore, , Singapore
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SIG18037
Identifier Type: -
Identifier Source: org_study_id
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