Clinical trial NCT01411488: Comparative Study Between Two Fecal Management Systems
Official title: Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Erosion
Keywords: Focus: anal erosion
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Bard Ltd
First posted: 2011-08-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 Groups were randomly assigned to 1 of 2 different fecal management systems
Primary purpose: SUPPORTIVE_CARE

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.

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
  * 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

Primary outcomes:
measure: Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Nancy Albert, PhD
role: STUDY_CHAIR
References: