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N/A N=79 Randomized Supportive Care

Comparative Study Between Two Fecal Management Systems

Anal Erosion

Bottom Line

View on ClinicalTrials.gov: NCT01411488 ↗
Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS — 5; 5 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fecal management system (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Cleveland Clinic
Primary completion
May 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS		 5; 5 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01411488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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