Clinical evaluation of a flexible fecal incontinence management system.

Background: Management of fecal incontinence is a priority in acute and critical care to reduce risk of perineal dermatitis and transmission of nosocomial infections.

Objective: To evaluate the safety of the Flexi-Seal Fecal Management System in hospitalized patients with diarrhea and incontinence.

Methods: A prospective, single-arm clinical study with 42 patients from 7 hospitals in the United States was performed.