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Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis

Primary Purpose

Incontinence-associated Dermatitis

Status
Terminated
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
Conveen EasiCleanse and Conveen Critic Barrier
Standard cleansing and Conveen Critic Barrier
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence-associated Dermatitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tan Tock Seng Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant

Conveen EasiCleanse and Conveen Critic Barrier

Soap and water / Incontinence wipes and Conveen Critic Barrier

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced IAD Healing
Total number of participants who experienced IAD healing
Proportion of Participants With IAD Healing
Percentage of participants who experienced IAD healing

Secondary Outcome Measures

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)

Full Information

First Posted
October 6, 2020
Last Updated
May 3, 2021
Sponsor
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04625426
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Early termination due to COVID-19 pandemic led to inability to reach planned sample size
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence-associated Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomised trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant
Arm Type
Experimental
Arm Description
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.
Arm Title
Conveen EasiCleanse and Conveen Critic Barrier
Arm Type
Experimental
Arm Description
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.
Arm Title
Soap and water / Incontinence wipes and Conveen Critic Barrier
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
Intervention Description
Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
Intervention Type
Device
Intervention Name(s)
Conveen EasiCleanse and Conveen Critic Barrier
Intervention Description
Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
Intervention Type
Device
Intervention Name(s)
Standard cleansing and Conveen Critic Barrier
Intervention Description
Hospital's standard care for IAD management
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced IAD Healing
Description
Total number of participants who experienced IAD healing
Time Frame
Up to seven days from initiation of treatment
Title
Proportion of Participants With IAD Healing
Description
Percentage of participants who experienced IAD healing
Time Frame
Up to seven days from initiation of treatment
Secondary Outcome Measure Information:
Title
Number of Participants Who Developed Skin Loss
Description
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)
Time Frame
Up to three days from initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ee Yuee Chan
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cheng Cheng Goh
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share IPD to other researchers.
Citations:
PubMed Identifier
27841440
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.
Results Reference
background
PubMed Identifier
31605618
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.
Results Reference
background
PubMed Identifier
29243033
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.
Results Reference
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Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis

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