Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
NCT ID: NCT03298113
Last Updated: 2024-12-02
Study Results
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View full resultsBasic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2017-11-17
2018-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cavilon Advanced Skin Protectant
Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.
Cavilon Advanced Skin Protectant
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.
IAD Hospital Standard Care
Marketed products are applied according to the IAD hospital standard care routine.
IAD Hospital Standard Care
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.
Interventions
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Cavilon Advanced Skin Protectant
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.
IAD Hospital Standard Care
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.
Eligibility Criteria
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Inclusion Criteria
2. Has the patient or their legally authorized representative signed the Informed Consent Form?
3. 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?
4. Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
5. Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
6. Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?
Exclusion Criteria
2. Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
3. Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
4. Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
5. Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
6. Does the patient have any other local dermatological disease or skin condition interfering with this study?
7. 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?
8. Does the patient participate in another study with a known or implied effect on skin barrier function?
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew M. Cooper, MD
Role: STUDY_DIRECTOR
3M
Locations
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Universitair Ziekenhuis Gent
Ghent, East Flanders, Belgium
Charité - Universitätsmedizin Berlin
Berlin, , Germany
University Hospital Southampton
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLIN-PROT-EU-05-293312
Identifier Type: -
Identifier Source: org_study_id