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

Not Applicable
Terminated
Conditions
Incontinence-associated Dermatitis
Interventions
Device: Conveen EasiCleanse and Conveen Critic Barrier
Device: Standard cleansing and Conveen Critic Barrier
Device: 3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant
Registration Number
NCT04625426
Lead Sponsor
Tan Tock Seng Hospital
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
86
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conveen EasiCleanse and Conveen Critic BarrierConveen EasiCleanse and Conveen Critic BarrierSkin 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.
Soap and water / Incontinence wipes and Conveen Critic BarrierStandard cleansing and Conveen Critic BarrierSkin 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.
3M No-Rinse Cleanser and 3M Cavilon Advanced Skin Protectant3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin ProtectantSkin 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.
Primary Outcome Measures
NameTimeMethod
Proportion of Participants With IAD HealingUp to seven days from initiation of treatment

Percentage of participants who experienced IAD healing

Number of Participants Who Experienced IAD HealingUp to seven days from initiation of treatment

Total number of participants who experienced IAD healing

Secondary Outcome Measures
NameTimeMethod
Number of Participants Who Developed Skin LossUp 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)

Trial Locations

Locations (1)

Tan Tock Seng Hospital

🇸🇬

Singapore, Singapore

Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
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