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| Name | Class |
|---|---|
| Bard Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Management System- Company 1 | Experimental | 80 adult patients to be randomly assigned to receive a fecal management system by Bard Medical |
|
| Fecal Management System- Company 2 | Active Comparator | 80 adult patients to be randomly assigned to receive a fecal management system by ConvaTec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal management system | Device | rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS | anal erosion within 14 days after insertion of FMS | up to 14 days |
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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
Exclusion Criteria:
Allergic to product components
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Albert, PhD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
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An interim analysis was completed; see recruitment details
An interim analysis was planned one 70+ patients completed data collection to determine futility vs continued recruitment, enrollment and data collection.
The analysis presented represents the interim analysis as it was determines that we should stop further recruitment and enrollment based on study findings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Management System- Company 1 | 47 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions Note, not all patients were retained |
| FG001 | Fecal Management System- Company 2 | 43 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions Note: not all patients were retained |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Management System- Company 1 | 41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions 55% male; 60% had history of hemorrhoids |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS | anal erosion within 14 days after insertion of FMS | Pearson's chi square test (categorical data) and Wilcoxon test (continuous measures). Logistic regression was used to assess primary endpoint by time the device was in use. | Posted | Count of Participants | Participants | up to 14 days |
|
During data collection for each subject. No follow up data collection
Since rectal tube insertion is usual care, patient adverse evens were not recorded, only adverse events related to rectal tube care specifically
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fecal Management System- Company 1 | 41 adult patients to be randomly assigned to receive a fecal management system by Bard Medical Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| did not get to day 1 or could not tolerate | Gastrointestinal disorders | Systematic Assessment | rectal tube was not maintained for 24 hours |
Single center Small sample size restricted to medical intensive care and other adults requiring rectal tube placement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Albert | Cleveland Clinic | 216-444-7028 | albertn@ccf.org |
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2 Groups were randomly assigned to 1 of 2 different fecal management systems
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| Fecal Management System- Company 2 |
38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions 45% male; 39.1% had history of hemorrhoids |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions |
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| 0 |
| 41 |
| 0 |
| 41 |
| 3 |
| 41 |
| EG001 | Fecal Management System- Company 2 | 38 adult patients to be randomly assigned to receive a fecal management system by ConvaTec Fecal management system: rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions | 0 | 38 | 0 | 38 | 2 | 38 |
|
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