Managing fecal incontinence and diarrhea challenges intensive care unit (ICU) and hospital staff. An innovative fecal management system (F*) uses an inflated balloon to retain a tube within the rectum. An external pouch collects fecal material for patients with uncontrolled diarrhea. This prospective study evaluated safety and performance of F in 42 subjects with diarrhea and incontinence in 7 US hospitals. Endoscopic rectal vault proctoscopies assessed anorectal mucosal condition pre-insertion and post-removal on 8 initial subjects. Investigators reported on ease of F insertion and removal, device retention and leakage, patient comfort, perineal skin condition and odor during use. F performed well with duration of use ranging from 1 to 14 days. The device was generally well-tolerated. Five deaths occurred from non-product-related illnesses and one subject with multi-system organ disease and history of GI bleed had an episode of lower GI bleeding while using the device. Clinicians rated F easy-to-insert (97% of subjects rated), remove (97%) and dispose of (100%) with easy-to-follow instructions (100%). On 200 daily assessments, F was rated as improving fecal incontinence control in 83%, as time efficient in 89% and as efficacious in 86%. Four subjects were unable to retain the device. Clinicians reported no odor on 85% of daily assessments and no or limited leakage on 82%. In this setting of diarrhea and incontinence, perineal and buttock skin condition were maintained/improved in 92% of patients. The device was determined to have an overall favorable safety profile in this study, helping reduce risk of perineal and buttock skin breakdown.

Product notation: *Flexi-SealŪ Fecal Management System, ConvaTec, Princeton, NJ, USA. Flexi-Seal is a registered trademark of E. R. Squibb & Sons, L. L. C.