The study was a prospective, single-arm, clinical study.¹

Forty two subjects took part in the study, where all were evaluated for safety and 38 were evaluated for efficacy. Subjects were enrolled when the following criteria were met:

• Admission to an acute-care facility
• Legal consenting age and informed, written consent
• Incontinence of liquid or semiliquid stool
• No recent rectal surgery
• No lower large bowel anastomosis within the past year
• No cardiac event requiring hospitalization within the past 3 months

Each study center had at least one physician as investigator, and most centers had a registered nurse who acted as a study coordinator.

At enrollment, the investigator performed a digital rectal exam on each subject to verify the contents of the rectal vault. If the subject had an impaction, he or she could only be considered for enrollment if the investigator manually removed the impaction, and clinical assessment warranted use of the device. Endoscopic proctoscopies of the rectal vault were performed on the initial 11 subjects, who were recruited from ICUs before and on 8 subjects after use of the study device in order to assess the anorectal mucosal condition. Any observed changes after the device was used were documented.

Parameters that were identified daily by caregivers to assess safety and efficacy were

Efficacy

• Device retention
• Ease of insertion and removal
• Leakage around device
• Perianal skin condition
• Presence or absence of odor

Safety

• Adverse events
• Endoscopic proctoscopy (first 11 subjects)

Of 42 subjects

• Mean age: 60.7 years¹
• Sex: 62% female, 38% male¹
• Mean treatment time: 5.6 days¹

EFFICACY¹

SAFETY¹

Maintained or improved skin condition was observed in 92% of subjects¹

• Flexi-Seal^® FMS was efficacious and time-efficient for fecal management¹
• Flexi-Seal^® FMS was easy to use and practical¹
• Minimal or no leakage was observed in 82% of assessments¹
• Flexi-Seal^® FMS had an overall favorable safety profile¹