Incontinence Associated Dermatitis Clinical Trial
Official title:
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02080247 -
Treatment of Incontinence Associated Dermatitis in Older Children and Adults
|
Phase 3 | |
| Withdrawn |
NCT05471180 -
Adjuvant Effect of Photobiomodulation in the Treatment of Incontinence-associated Dermatitis in Adults
|
N/A |