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

Overview

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

Full Title of Study: “Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 20, 2020

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.

Interventions

  • Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
    • Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
  • Device: Conveen EasiCleanse and Conveen Critic Barrier
    • Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
  • Device: Standard cleansing and Conveen Critic Barrier
    • Hospital’s standard care for IAD management

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Who Experienced IAD Healing
    • Time Frame: Up to seven days from initiation of treatment
    • Total number of participants who experienced IAD healing
  • Proportion of Participants With IAD Healing
    • Time Frame: Up to seven days from initiation of treatment
    • Percentage of participants who experienced IAD healing

Secondary Measures

  • Number of Participants Who Developed Skin Loss
    • Time Frame: Up to three days from initiation of treatment
    • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tan Tock Seng Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ee Yuee Chan, Study Director, Tan Tock Seng Hospital
    • Cheng Cheng Goh, Principal Investigator, Tan Tock Seng Hospital

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.