Trials / Withdrawn
WithdrawnNCT03816384
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Potrero Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs. The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.
Detailed description
Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs. The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard of Care | Standard of care urinary drainage system. |
| DEVICE | DLC Group | Urinary drainage system with active drain line clearance and plain silicone catheter. |
| DEVICE | DLCS Group | Urinary drainage system with active drain line clearance and silver-doped silicone catheter. |
Timeline
- Start date
- 2020-01-31
- Primary completion
- 2020-01-31
- Completion
- 2020-01-31
- First posted
- 2019-01-25
- Last updated
- 2020-01-29
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03816384. Inclusion in this directory is not an endorsement.