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

NCT04625426 | Terminated Results

• 1 other identifier: SIG18037
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Incontinence-associated Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Number of Participants Who Developed Skin Loss

  Up to three days from initiation of treatment

Study Arms (3)

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.

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

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.

Device: Conveen EasiCleanse and Conveen Critic Barrier

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.

Device: Standard cleansing and Conveen Critic Barrier

Interventions

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

Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant

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

Conveen EasiCleanse and Conveen Critic Barrier DEVICE

Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream

Conveen EasiCleanse and Conveen Critic Barrier

Standard cleansing and Conveen Critic Barrier DEVICE

Hospital's standard care for IAD management

Soap and water / Incontinence wipes and Conveen Critic Barrier

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 years and above at point of recruitment
• Diagnosed with IAD
• At regular risk of exposure to urine and faeces over their hospitalization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 27841440 BACKGROUND

• 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.

  PMID: 31605618 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.

  PMID: 29243033 BACKGROUND

Limitations and Caveats

Early termination due to COVID-19 pandemic led to inability to reach planned sample size.

Results Point of Contact

• Title: George Glass, Nurse Researcher
• Organization: Tan Tock Seng Hospital

glass_george_frederick@ttsh.com.sg

+65 6903-5440

Study Officials

• Ee Yuee Chan

  Tan Tock Seng Hospital

  STUDY DIRECTOR

• Cheng Cheng Goh

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised trial

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: November 12, 2020
• Study Start: April 29, 2019
• Primary Completion: January 20, 2020
• Study Completion: September 30, 2020
• Last Updated: May 5, 2021
• Results First Posted: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)