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Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.
A superiority study evaluating the efficacy of a complete cleansing system composed of 5 prepackaged, moistened cloths with a standardized cleaning method compared to the previous standard-of-care for catheter care and maintenance. The primary objective is to investigate if the implementation of prepackaged cleansing cloths with a standardized cleaning protocol for all indwelling urinary catheter (IUC) care and maintenance provides a reduction in CAUTIs. The ReadyCleanse complete cleansing system will replace the previous standard-of-care. The ReadyCleanse intervention will be compared to the previous standard-of-care retrospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReadyCleanse for IUC | Other | ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReadyCleanse Cloths | Device | ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode. |
| Measure | Description | Time Frame |
|---|---|---|
| Infections Per 1,000 (CAUTI) Days | Incidence Rate for CAUTIs per 1,000 Catheter days | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of "Health Care Providers Responding to Health Care Provider Feedback Survey | Healthcare provider feedback survey will be delivered to all staff that have utilized the ReadyCleanse cloths for indwelling urinary catheter care and maintenance. Purpose of the survey is to investigate healthcare provider preference and opinion of device. | Begins 3 months after start date. Time to take survey is approximately 10 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal S Singh, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem - Evanston | Evanston | Illinois | 60201 | United States | ||
| NorthShore University HealthSystem - Glenbrook |
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| ID | Title | Description |
|---|---|---|
| FG000 | ReadyCleanse for IUC | ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used. ReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2019 |
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Intervention in the standard of care for indwelling urinary catheter care and maintenance.
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| Glenview |
| Illinois |
| 60026 |
| United States |
| NorthShore University HealthSystem - Highland Park | Highland Park | Illinois | 60035 | United States |
| NorthShore University HealthSystem - Skokie | Skokie | Illinois | 60076 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ReadyCleanse for IUC | ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used. ReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Infections Per 1,000 (CAUTI) Days | Incidence Rate for CAUTIs per 1,000 Catheter days | Posted | Number | 95% Confidence Interval | infection per 1,000 catheter days | 16 months |
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| Secondary | Number of "Health Care Providers Responding to Health Care Provider Feedback Survey | Healthcare provider feedback survey will be delivered to all staff that have utilized the ReadyCleanse cloths for indwelling urinary catheter care and maintenance. Purpose of the survey is to investigate healthcare provider preference and opinion of device. | Health Care Providers | Posted | Count of Participants | Participants | Begins 3 months after start date. Time to take survey is approximately 10 minutes. |
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Participant Duration: Participant had an IUC inserted during their hospital stay, through study completion, an average of 4 days with 61 being the maximum number of days.
If the condition of the participant's perineal skin and soft-tissue deteriorates unexpectedly, per the PI's interpretation, or if there is a new condition that the PI determines is not related to the baseline health condition but could be related to the use of the study product, it will be recorded as an AE.
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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 | ReadyCleanse for IUC | ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used. ReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode. | 0 | 9,872 | 0 | 9,872 | 0 | 9,872 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keri Jorgenson | Medline Industries, LP | 2243014670 | kajorgenson@medline.com |
| Oct 20, 2021 |
| Prot_SAP_000.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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