N/A Completed N=79 Randomized Supportive Care

Comparative Study Between Two Fecal Management Systems

Anal Erosion

Source: ClinicalTrials.gov NCT01411488 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcomePrimary: Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS — 5; 5 Participants

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.

Outcome Measures

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

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. Informational only — not medical advice.