Comparative Study Between Two Fecal Management Systems

NCT ID: NCT01411488

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Anal Erosion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fecal Management System- Company 1

80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical

Group Type: EXPERIMENTAL

Fecal management system

Intervention Type: DEVICE

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

Fecal Management System- Company 2

80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec

Group Type: ACTIVE_COMPARATOR

Fecal management system

Intervention Type: DEVICE

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

Interventions

Fecal management system

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

Intervention Type: DEVICE

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

Exclusion Criteria

• If on subcutaneous anti-coagulation to prevent deep vein thrombosis, then can be included in study

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bard Ltd

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Nancy M. Albert, Ph.D.

Cleveland Clinic Foundation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Albert, PhD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

10-1098

Identifier Type: -

Identifier Source: org_study_id