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American Journal of Critical Care. 2007;16: 384-393
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Clinical Evaluation of a Flexible Fecal Incontinence Management System

By Anantha Padmanabhan, MD, Mark Stern, MD, Judith Wishin, RN, BSN, Mari Mangino, RN, Karen Richey, RN, Mary DeSane, RN, BSN on behalf of the Flexi-Seal Clinical Trial Investigators Group. Anantha Padmanabhan is chair of the Department of Surgery at Mt Carmel East Hospital and clinical assistant professor of surgery at Ohio State University in Columbus. Mark Stern is the founder of the Atlanta Academic Research Group in Decatur, Georgia. Judith Wishin is the senior clinical research coordinator for the surgical intensive care unit at the University of Florida, Gainesville. Mari Mangino is a clinical nurse research coordinator at Forum Health in Youngstown, Ohio. Karen Richey is the senior clinical research coordinator at the Arizona Burn Center in Phoenix. Mary DeSane is the operations manager in the Office of Clinical Research at Jersey Shore University Medical Center, Neptune, New Jersey.

Corresponding author: Anantha Padmanabhan, MD, FACS, FASCRS, 5965 E Broad St, Suite 250, Columbus, OH 43213 (e-mail: apaddy{at}phy.mchs.com).

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. The fecal management system could be used for up to 29 days. The first 11 patients (all from critical care) underwent endoscopic 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 management 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 irritation 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, controlled clinical trials may help to measure clinical and economic outcomes associated with the device.


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