Comparative Study Between Two Fecal Management Systems

Not Applicable

Completed

• Conditions: Anal Erosion
• Interventions: Device: Fecal management system

• Registration Number: NCT01411488
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2017-04-18
• Results First Submitted QC: 2017-08-16
• Results First Posted: 2017-09-14
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Management System- Company 2	Fecal management system	80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec
Fecal Management System- Company 1	Fecal management system	80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical

Primary Outcome Measures

Name	Time	Method
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS	up to 14 days	anal erosion within 14 days after insertion of FMS

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States