Status:
COMPLETED
Comparative Study Between Two Fecal Management Systems
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Bard Ltd
Conditions:
Anal Erosion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01411488
Start Date
January 1 2011
End Date
May 1 2012
Last Update
July 30 2020
Active Locations (1)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195