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Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.
The use of urinary catheters is a common medical practice in the perioperative setting.
As such, it exposes the patient to certain comorbidities, including urinary tract infections.
The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.
Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receive active UroShield device | Active Comparator | Patients receive active UroShield device |
|
| Patients receive inactive UroShield device | Sham Comparator | Patients receive inactive UroShield device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroShield device | Device | The UroShield device is Consists of two units:Actuator and Driver. |
|
| Measure | Description | Time Frame |
|---|---|---|
| side effects and complications of urinary catheter usage | the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham UroShield device | Device |
|