CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Fecal management systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01411488
NCT01411488N/ACompleted
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Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion.

The Cleveland Clinic·interventional·Posted Aug 8, 2011·Updated Jul 30, 2020

In Brief

A clinical study evaluating Fecal management system for Anal Erosion. Completed, enrolled 90 participants across 1 site.

Detailed 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 (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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Erosion
CountriesUnited States
CollaboratorsBard Ltd

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2011
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.9 years ago

Interventions

Fecal management systemdevice

rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions