of the Flexi-Seal Clinical Trial Investigators Group

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 hospi-tals in the United States was performed. The fecal management system could be used for up to 29 days. The first 11 patients (all from critical care) underwent endo-scopic proctoscopy at baseline; 8 of these had endoscopy again after treatment. The remaining 31 patients (from critical or acute care) did not have endoscopy. Results Rectal mucosa was healthy after use of the device in all patients who had baseline and follow-up endoscopy. Physicians and nurses reported that the system was easy to insert, remove, and dispose of; its use improved manage-ment of fecal incontinence; and it was practical, caregiver- and patient-friendly, time-efficient, and efficacious. Skin condition improved or was maintained in more than 92 % of patients. Patients ’ reports of discomfort, pain, burning, or irri-tation were uncommon. Adverse events were reported for 11 patients (26%). Death (considered unrelated to study treatment) occurred in 5 patients, 2 patients had generalized skin breakdown, and 1 patient had gastrointestinal bleeding after 4 days of treatment. Conclusions The fecal management system can be used safely in hospitalized patients with diarrhea and fecal incontinence. Additional well-designed, con-trolled clinical trials may help to measure clinical and economic outcomes asso