NCT02570139

Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing

Multi-Center, Randomized Trial Comparing the Efficacy of 3M™ Cavilon™ Advanced Barrier Film for the Treatment of Incontinence-associated Dermatitis to a Commercially Available Moisture Barrier

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 1 Hour
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.

Detailed description

The purpose of this study is to evaluated the product performance of a new skin protectant formulated to protect damaged and denuded skin even in the presence of exposure to the most potentially damaging body fluids, such as liquid stool and gastric fluid. The product is expected to intimately adhere to damaged and denuded skin and provide better protection from further damage than commonly used products such as moisture barrier pastes, thereby making it easier for nursing staff to cleanse the skin after incontinence episodes, thus saving time and also materials. The denuded sites on buttocks/thighs will be scored for skin loss and degree of redness. Over the course of time, with the skin protected, it should re-epithelizes. The skin improvement will be scored and the change in baseline over time monitored.

Conditions

• Incontinence Associated Dermatitis

Interventions

Type	Name	Description
DEVICE	Cavilon Advanced Skin Protectant	The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence.
DEVICE	ConvaTec Sensi-Care Protective Barrier	Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-06-23
• Completion: 2017-06-23
• First posted: 2015-10-07
• Last updated: 2024-10-02
• Results posted: 2018-10-12

Locations

10 sites across 1 country: United States