Comparative Study Between Two Fecal Management Systems
Recruitment status was Recruiting
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.
|Study Design:||Time Perspective: Prospective|
- anal erosion within 14 days after insertion of FMS [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
|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)|
Fecal Management System
Cohort of 160 adult patients randomly assigned to one of two fecal management systems
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411488
|Contact: Mary Ann (Molly) Sammon, BSN||216-444-2778||Sammonm@ccf.org|
|Contact: Mary Beth Zeni, ScDfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland Clinic Main Campus||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Sammon Sammonm@ccf.org|