Incontinence-associated Dermatitis Clinical Trial
Official title:
Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study
Verified date | May 2021 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital |
Singapore,
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
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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