Catheter-Associated Urinary Tract Infection
Conditions
Brief summary
Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.
Detailed description
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.
Interventions
DEVICEReadyCleanse 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.
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention in the standard of care for indwelling urinary catheter care and maintenance.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* any adult patient who requires an IUC to be placed during admission to one of the four study hospitals
Exclusion criteria
* patients \<18 years of age * patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor & delivery or postpartum units, and emergency room
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infections Per 1,000 (CAUTI) Days | 16 months | Incidence Rate for CAUTIs per 1,000 Catheter days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Health Care Providers Responding to Health Care Provider Feedback Survey | Begins 3 months after start date. Time to take survey is approximately 10 minutes. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9,891 |
| Total | 9,891 |
Baseline characteristics
| Characteristic | ReadyCleanse for IUC |
|---|---|
| Age, Continuous | 37.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 457 Participants |
| Race (NIH/OMB) Black or African American | 530 Participants |
| Race (NIH/OMB) More than one race | 204 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1587 Participants |
| Race (NIH/OMB) White | 7105 Participants |
| Region of Enrollment United States | 9891 participants |
| Sex: Female, Male Female | 4540 Participants |
| Sex: Female, Male Male | 5351 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9,872 |
| other Total, other adverse events | 0 / 9,872 |
| serious Total, serious adverse events | 0 / 9,872 |
Outcome results
Primary
Infections Per 1,000 (CAUTI) Days
Incidence Rate for CAUTIs per 1,000 Catheter days
Time frame: 16 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ReadyCleanse for IUC | Infections Per 1,000 (CAUTI) Days | 0.8429 infection per 1,000 catheter days |
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.
Time frame: Begins 3 months after start date. Time to take survey is approximately 10 minutes.
Population: Health Care Providers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReadyCleanse for IUC | Number of Health Care Providers Responding to Health Care Provider Feedback Survey | 121 Participants |