Anal Erosion
Conditions
Keywords
Focus: anal erosion
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.
Interventions
DEVICEFecal management system
rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions
Sponsors
Bard Ltd
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
2 Groups were randomly assigned to 1 of 2 different fecal management systems
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS | up to 14 days | anal erosion within 14 days after insertion of FMS |
Countries
United States
Participant flow
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.
Pre-assignment details
An interim analysis was completed; see recruitment details
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| 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 | 38 |
| Total | 79 |
Baseline characteristics
| Characteristic | Fecal Management System- Company 1 | Fecal Management System- Company 2 | Total |
|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 15 | 64.7 years STANDARD_DEVIATION 12.3 | 64.0 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 21 Participants | 17 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 38 |
| other Total, other adverse events | 3 / 41 | 2 / 38 |
| serious Total, serious adverse events | 0 / 41 | 0 / 38 |
Outcome results
Primary
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS
anal erosion within 14 days after insertion of FMS
Time frame: up to 14 days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Management System- Company 1 | Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS | 5 Participants |
| Fecal Management System- Company 2 | Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS | 5 Participants |