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Early termination due to COVID-19 pandemic led to inability to reach planned sample size
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant | Experimental | 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. |
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| Conveen EasiCleanse and Conveen Critic Barrier | Experimental | 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. |
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| Soap and water / Incontinence wipes and Conveen Critic Barrier | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant | Device | Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced IAD Healing | Total number of participants who experienced IAD healing | Up to seven days from initiation of treatment |
| Proportion of Participants With IAD Healing | Percentage of participants who experienced IAD healing | Up to seven days from initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ee Yuee Chan | Tan Tock Seng Hospital | Study Director |
| Cheng Cheng Goh | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27841440 | Background | 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. | |
| 31605618 |
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No plans to share IPD to other researchers.
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2 participants initially recruited were found to be not eligible before being assigned to an arm, leading to them being dropped from the study before assignation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2020 |
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Cluster randomised trial
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| Conveen EasiCleanse and Conveen Critic Barrier | Device | Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream |
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| Standard cleansing and Conveen Critic Barrier | Device | Hospital's standard care for IAD management |
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| 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. |
| 29243033 | Background | 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. |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Type of incontinence | Number | participants |
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| Faecal frequency | Mean | Standard Deviation | episodes/day |
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| Presence of indwelling urinary catheter | Count of Participants | Participants |
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| Stool consistency | Stool consistency measured using Bristol Stool Chart. The chart grades stool by 7 types Types 3 and 4 are ideal, reflecting smooth,easy-to-pass stool Types 1 and 2 are not ideal as they indicate diarrhoea Types 5, 6 and 7 are not ideal as they indicate diarrhoea Type 1: Separate hard lumps, hard to pass Type 2: Separate hard lumps, hard to pass Type 3, Type 4: Ideal stool consistency, smooth Type 5: Soft blobs with clear-cut edges Type 6: Mushy, fluffy stool Type 7: Watery, entirely liquid | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced IAD Healing | Total number of participants who experienced IAD healing | Posted | Count of Participants | Participants | Up to seven days from initiation of treatment |
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| Primary | Proportion of Participants With IAD Healing | Percentage of participants who experienced IAD healing | Posted | Number | percentage of participants | Up to seven days from initiation of treatment |
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| 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) | Posted | Count of Participants | Participants | Up to three days from initiation of treatment |
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Adverse data not collected over study period. This is because the interventions were assessed to have minimal risk of harm on participants.
All-Cause Mortality, Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed as interventions were assessed to have minimal risk of harm on participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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Early termination due to COVID-19 pandemic led to inability to reach planned sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Glass, Nurse Researcher | Tan Tock Seng Hospital | +65 6903-5440 | glass_george_frederick@ttsh.com.sg |
| Apr 8, 2021 |
| Prot_SAP_000.pdf |
| Male |
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| Malay |
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| Indian |
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| Faecal incontinence |
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| Dual incontinence |
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| Type 5 (Second-best) |
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| Type 6 (Third-best outcome) |
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| Type 7 (Worst outcome) |
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| Missing |
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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
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| 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 |
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