Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis

Study Overview
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Brief Summary
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The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)

Detailed Description
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The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: incontinence-associated dermatitis). IAD is a skin damage caused by exposure to moisture and irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to severe erosion and denudation/skin loss with or without secondary infection. The durable, long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin surfaces (i.e., superficial, partial thickness skin loss) to provide better protection against moisture and irritants under challenging conditions.

Official Title
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Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial

Conditions
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Incontinence-associated Dermatitis

Intervention / Treatment
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* Device: Cavilon Advanced Skin Protectant
* Device: IAD Hospital Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is the patient 18 years or older? Has the patient or their legally authorized representative signed the Informed Consent Form? Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold? Is the patient incontinent and does stool and/or urine come into direct contact with the skin? Is the patient able to be turned/positioned with regard to skin assessment and photo documentation? Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days? Exclusion Criteria: Is the patient pregnant or breast feeding? Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate? Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area? Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area? Does the patient require treatment with topical medication or product other than IAD treatment in the study area? Does the patient have any other local dermatological disease or skin condition interfering with this study? Does the patient have any medical condition (e.g. end of life, planned elective surgery) that in the opinion of the investigator should exclude him/her from participating in the study? Does the patient participate in another study with a known or implied effect on skin barrier function?

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavilon Advanced Skin Protectant<br>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. | Device: Cavilon Advanced Skin Protectant<br>* Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.<br>|
| Other: IAD Hospital Standard Care<br>Marketed products are applied according to the IAD hospital standard care routine. | Device: IAD Hospital Standard Care<br>* Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of IAD | Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool) Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is other pre-specified. The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital. | up to 21 days depending on length of hospitalization |