Comparative Study Between Two Fecal Management Systems

Study Overview
=================
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 (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.

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. 90 patients were enrolled in the study. The number who started and completed the study; 41 of 47 received system A and 38 of 43 received system B. Subjects' mean age was 64 ± 13.6 years (mean ± SD), and 52% were female.

Official Title
-----------------
Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion.

Conditions
-----------------
Anal Erosion

Intervention / Treatment
-----------------
* Device: Fecal management system


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 Groups were randomly assigned to 1 of 2 different fecal management systems
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Management System- Company 1<br>80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical | Device: Fecal management system<br>* rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions<br>|
| Active Comparator: Fecal Management System- Company 2<br>80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec | Device: Fecal management system<br>* rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS | anal erosion within 14 days after insertion of FMS | up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focus: anal erosion