An interventional study of ReadyCleanse Cloths in Catheter-Associated Urinary Tract Infection, sponsored by Medline Industries. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Medline Industries · Not applicable, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 9,891 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Medline Industries is the lead sponsor of 38 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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.
Infections Per 1,000 (CAUTI) Days
Incidence Rate for CAUTIs per 1,000 Catheter days
Time frame: 16 months
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.
Time frame: Begins 3 months after start date. Time to take survey is approximately 10 minutes.
| Milestone | ReadyCleanse for IUC |
|---|---|
| Started | 9891 |
| Completed | 9891 |
| Not completed | 0 |
Incidence Rate for CAUTIs per 1,000 Catheter days
| infection per 1,000 catheter days | ReadyCleanse for IUC |
|---|---|
| Infections Per 1,000 (CAUTI) Days | 0.8429 (0.6080 to 1.1685) |
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.
| Participants | ReadyCleanse for IUC |
|---|---|
| Number of "Health Care Providers Responding to Health Care Provider Feedback Survey | 121 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ReadyCleanse for IUC | 0/9,872 (0%) | 0/9,872 (0%) | 0/9,872 (0%) |
| Age, Continuous(years) | ReadyCleanse for IUC |
|---|---|
| Mean | 37.1 (24 to 50) |
| Sex: Female, Male(Participants) | ReadyCleanse for IUC |
|---|---|
| Female | 4540 |
| Male | 5351 |
| Race (NIH/OMB)(Participants) | ReadyCleanse for IUC |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 457 |
| Native Hawaiian or Other Pacific Islander | 8 |
| Black or African American | 530 |
| White | 7105 |
| More than one race | 204 |
| Unknown or Not Reported | 1587 |
| Region of Enrollment(participants) | ReadyCleanse for IUC |
|---|---|
| United States | 9891 |
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Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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