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Comparative Study Between Two Fecal Management Systems

This study has been completed.
Bard Ltd
Information provided by (Responsible Party):
Nancy M. Albert, Ph.D., The Cleveland Clinic Identifier:
First received: August 5, 2011
Last updated: September 10, 2016
Last verified: September 2016

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 Intervention Phase
Anal Erosion
Device: Fecal management system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

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 ]

Enrollment: 79
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal Management System- Company 1
80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical
Device: Fecal management system
rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions
Active Comparator: Fecal Management System- Company 2
80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec
Device: Fecal management system
rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions

Detailed Description:
PURPOSE: To compare the incidence of anal erosion between 2 indwelling fecal management systems. Anal erosion was defi ned as localized mucous membrane tissue impairments of the anal canal caused by corrosive fecal enzymes and/or indwelling devices. DESIGN: Randomized comparative effectiveness clinical trial comparing 2 commercially available indwelling fecal management systems. SUBJECTS AND SETTING: The target population was adults cared for on medical, surgical, and neurological intensive care units (ICUs) and non-ICU units with an order for indwelling fecal management system placement. The research setting was a 1200-bed quaternary-care medical center in the Midwestern United States. Seventy-nine patients participated in the study; 41 received system A and 38 received system B. Subjects' mean age was 64 ± 13.6 years (mean ± SD), and 52% were female.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01411488

United States, Ohio
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Bard Ltd
Study Chair: Nancy Albert, PhD The Cleveland Clinic
  More Information

Responsible Party: Nancy M. Albert, Ph.D., Cleveland Clinic Foundation, The Cleveland Clinic Identifier: NCT01411488     History of Changes
Other Study ID Numbers: 10-1098
Study First Received: August 5, 2011
Last Updated: September 10, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Focus: anal erosion processed this record on April 25, 2017