Comparative Study Between Two Fecal Management Systems

NCT01411488 | Completed Results

• 1 other identifier: 10-1098
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Erosion

Keywords

Focus: anal erosion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fecal Management System- Company 1

EXPERIMENTAL

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

Device: Fecal management system

Fecal Management System- Company 2

ACTIVE COMPARATOR

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

Device: Fecal management system

Interventions

Fecal management system 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 1; Fecal Management System- Company 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Bard Ltd: collaborator

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Limitations and Caveats

Single center Small sample size restricted to medical intensive care and other adults requiring rectal tube placement

Results Point of Contact

• Title: Nancy Albert
• Organization: Cleveland Clinic

albertn@ccf.org

216-444-7028

Study Officials

• Nancy Albert, PhD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cleveland Clinic Foundation

Model Details: 2 Groups were randomly assigned to 1 of 2 different fecal management systems

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 30, 2020
• Results First Posted: September 14, 2017

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)