NCT03298113

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Incontinence-associated Dermatitis

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2017-11-17
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2017-10-02
• Last updated: 2024-12-02
• Results posted: 2019-09-24

Locations

3 sites across 3 countries: Belgium, Germany, United Kingdom

Regulatory

• FDA-regulated device study