Comparative Study Between Two Fecal Management Systems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by The Cleveland Clinic.
Recruitment status was  Recruiting
Information provided by:
The Cleveland Clinic Identifier:
First received: August 5, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

The purpose of the study is to determine the prevalence of anal erosions within a 14 day period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal management systems (FMS).

Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal management systems in a 14 day period.

Alternative Hypothesis: One fecal management system is no worse than the second fecal management system in the development of anal erosion.

Anal Erosion

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • anal erosion within 14 days after insertion of FMS [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Fecal Management System
Cohort of 160 adult patients randomly assigned to one of two fecal management systems


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitalized adult patients who have a fecal managment systems ordered

Inclusion Criteria:

  • Bedfast patients who need to have liquid or semi-liquid stool contained away from the body to prevent skin breakdown or contamination of existing wounds

    • Liquid to semi-liquid stool incontinence for past three days that is expected to last for extended period due to poor response to anti-diarrheal treatment
    • Absence of contraindications listed in Exclusion Criteria
    • If on subcutaneous anti-coagulation to prevent deep vein thrombosis, then can be included in study

Exclusion Criteria:

  • Allergic to product components

    • Rectal or anal injury or active bleeding
    • Severe rectal or anal stricture or stenosis (distal rectum cannot accommodate the balloon), diseases of the rectal mucosa (i.e. severe proctitis, ischemic proctitis, mucosal lacerations)
    • Rectal or anal tumors
    • Severe hemorrhoids
    • Fecal impaction
    • Loss of rectal tone or prolapsed anal sphincter
    • History of Ileo-anal anastamosis or internal rectal pouch (e.g. S or J pouch)
    • Large Bowel (Colon) surgery or rectal surgery within the last year
    • Currently on heparin drip
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01411488

Contact: Mary Ann (Molly) Sammon, BSN 216-444-2778
Contact: Mary Beth Zeni, ScD 216-445-3355

United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sammon   
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Mary Ann (Molly) Sammon, BSN, CWCN, RN, Cleveland Clinic Identifier: NCT01411488     History of Changes
Other Study ID Numbers: 10-1098
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Focus: anal erosion processed this record on November 30, 2015