Comparative Study Between Two Fecal Management Systems

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

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 Overview

• Status: Completed
• Conditions: Anal Erosion
• Intervention / Treatment: Device: Fecal management system

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Bard Ltd
• Investigators: Study Chair: Nancy Albert, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Focus: anal erosion
• Other Study ID Numbers: 10-1098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No