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Comparative Study Between Two Fecal Management Systems

This study has been completed.
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
Nancy M. Albert, Ph.D., The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01411488
First received: August 5, 2011
Last updated: September 10, 2016
Last verified: September 2016
  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 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 ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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 ClinicalTrials.gov identifier: NCT01411488

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

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

Keywords provided by The Cleveland Clinic:
Focus: anal erosion

ClinicalTrials.gov processed this record on September 26, 2016