Status:
ENROLLING_BY_INVITATION
Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals
Lead Sponsor:
University Ghent
Collaborating Sponsors:
3M
Conditions:
Irritant Dermatitis
Stoma Site Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wou...
Detailed Description
Problem statement: Partial-thickness wounds (erosion/denudation of the epithelial and dermal layers of the skin) can occur due to prolonged exposure of moisture and irritants. Various sources of mois...
Eligibility Criteria
Inclusion
- The patient or their legally authorized representative signed informed consent.
- The patient is expected to be in the study for the full duration of the trial.
- The patient has partial thickness wounds caused by moisture (MASD) i.e.,
- The patient has IAD category 2A or
- Peri-wound MASD or
- Peri-stomal MASD.
Exclusion
- Patients with a known hypersensitivity or allergy to acrylate or cyanoacrylate.
- The patient requires topical treatment due to a fungal, bacterial or viral infection in the study area.
- Intertriginous dermatitis (most often a fungal infection is present).
- Peri-fistula MASD (would usually require hospitalization).
- The patient has any other local dermatological disease or skin condition interfering with this study.
- Patients participating in another study with a known or implied effect on skin barrier function.
- Patients who are receiving end-of-life care.
Key Trial Info
Start Date :
January 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06178289
Start Date
January 27 2025
End Date
August 1 2026
Last Update
December 17 2025
Active Locations (3)
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1
Ziekenhuis Aan de Stroom (ZAS)
Antwerp, Belgium, 2030
2
Ghent University Hospital
Ghent, Belgium
3
AZ Oudenaarde
Oudenaarde, Belgium