Trial Outcomes & Findings for Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates (NCT NCT03645967)
NCT ID: NCT03645967
Last Updated: 2024-07-03
Results Overview
Incidence Rate for CAUTIs per 1,000 Catheter days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9891 participants
Primary outcome timeframe
16 months
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
9891
|
|
Overall Study
COMPLETED
|
9891
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
Baseline characteristics by cohort
| Measure |
ReadyCleanse for IUC
n=9891 Participants
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.
|
|---|---|
|
Age, Continuous
|
37.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4540 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5351 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
457 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
530 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
204 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1587 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9891 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 monthsIncidence Rate for CAUTIs per 1,000 Catheter days
Outcome measures
| Measure |
ReadyCleanse for IUC
n=9872 Participants
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.
|
|---|---|
|
Infections Per 1,000 (CAUTI) Days
|
0.8429 infection per 1,000 catheter days
Interval 0.608 to 1.1685
|
SECONDARY outcome
Timeframe: Begins 3 months after start date. Time to take survey is approximately 10 minutes.Population: Health Care Providers
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.
Outcome measures
| Measure |
ReadyCleanse for IUC
n=121 Participants
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.
|
|---|---|
|
Number of "Health Care Providers Responding to Health Care Provider Feedback Survey
|
121 Participants
|
Adverse Events
ReadyCleanse for IUC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60