Anal ErosionNCT01411488
Comparative Study Between Two Fecal Management Systems
A study testing Fecal management system in people with Anal Erosion, run by The Cleveland Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Erosion
- What is being tested?
- Fecal management system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion.
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.
Read the 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.
- Conditions
- Anal Erosion
- Being tested
- Fecal management system
- Keywords
- Focus: anal erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal management systemDevice
rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions
| Study group | Role | What they receive |
|---|---|---|
| Fecal Management System- Company 1 | Experimental | 80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Receives: Device: Fecal management system |
| Fecal Management System- Company 2 | Active comparator | 80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Receives: Device: Fecal management system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS
anal erosion within 14 days after insertion of FMS
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anal ErosionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Groups were randomly assigned to 1 of 2 different fecal management systems
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Ltd
- Responsible party
- Principal investigator, Nancy M. Albert, Ph.D., The Cleveland Clinic
- Investigators
- Nancy Albert, PhD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411488
- Sponsor's protocol ID
- 10-1098
- Status last verified
- Jul 2020
- First submitted
- 5 Aug 2011
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion.
- ClinicalTrials.gov ID
- NCT01411488
- Acronym / sponsor ID
- 10-1098
- Conditions
- Anal Erosion
- Keywords
- Focus: anal erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Bard Ltd
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 14 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 Groups were randomly assigned to 1 of 2 different fecal management systems
| Arm | Type | Receives |
|---|---|---|
| Fecal Management System- Company 1 | Experimental | Device: Fecal management system80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical |
| Fecal Management System- Company 2 | Active comparator | Device: Fecal management system80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Allergic to product components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal management systemrectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions | Device | Fecal Management System- Company 1, Fecal Management System- Company 2 |
Primary outcome
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS
Time frame: up to 14 days
anal erosion within 14 days after insertion of FMS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Albert, PhD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal management system in people with Anal Erosion, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.