Comparative Study Between Two Fecal Management Systems
Completed · Not applicable
Conditions studied: Anal Erosion
In brief
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.
Key facts
- Study ID
- NCT01411488
- Run by
- The Cleveland Clinic
- People needed
- 90
- Starts
- 2011-01-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2020-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.