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Comparative Study Between Two Fecal Management Systems

This study is currently recruiting participants.
Verified August 2011 by The Cleveland Clinic
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01411488
First received: August 5, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition
Anal Erosion

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

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)
Groups/Cohorts
Fecal Management System
Cohort of 160 adult patients randomly assigned to one of two fecal management systems

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411488

Contacts
Contact: Mary Ann (Molly) Sammon, BSN 216-444-2778 Sammonm@ccf.org
Contact: Mary Beth Zeni, ScD 216-445-3355 zenim@ccf.org

Locations
United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sammon         Sammonm@ccf.org    
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Mary Ann (Molly) Sammon, BSN, CWCN, RN, Cleveland Clinic
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on June 18, 2013