A Pilot Clinical Study of a Safe and Efficient Stool Management System in Patients With Fecal Incontinence

Ashlee Garcia, BSN, RN, CWOCN, CFCN; Sally Fung, RN, MS; Karen Lou Kennedy-Evans, RN, FNP, APRN-BC


Wounds. 2017;29(12):E132-E138. 

In This Article


Nonclinical and clinical testing demonstrated that the SMK may be a superior alternative to existing closed-system solutions. The SMK exerts significantly less force upon the anorectal mucosa compared with IBCs during insertion, in situ use, withdrawal, and accidental expulsions. Poor sphincter tone precludes fecal management with IBCs, putting patients at risk for dislodgement and leakage.

The self-expanding diverter design obviates the need to anchor to the anorectal junction, enhancing fecal containment capability even for patients with weak or no sphincter tone. By assuming full rectal lumen, SMK may be used in situ for more extended periods as stool consistency improves. Clinical validation in both controlled and uncontrolled settings successfully established the usage of SMK in adult patients as a safe and effective alternative for fecal effluent diversion and protection for perineal and sacral skin with minimal leakage. There were no adverse effects of the device on the anorectal mucosa. This device may be a safer alternative to IBCs and can be used in more patients with multiple comorbidities.