Comparative Study Between Two Fecal Management Systems

NeuroTherapia, Inc.

Status: Completed

Conditions: Anal Erosion

Treatments: Device: Fecal management system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01411488

10-1098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Fecal Management System- Company 1

Experimental group

Description:

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

Treatment:

Device: Fecal management system

Fecal Management System- Company 2

Active Comparator group

Description:

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

Treatment:

Device: Fecal management system