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Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use.
If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glenbrook Hospital | Active Comparator | Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only. |
|
| Evanston, Highland Park, Skokie Hospitals | Active Comparator | Phase 1: Assess baseline contamination rate for patients with PICC catheters for 3-12 months. Phase 2: Implement intervention. Assess contamination 3-12 months. Phase 3: (optional): Remove cap asses contamination rate (3-6 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disinfecting Cap | Device | Replace standard practice with using the disinfecting cap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml | For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube. | Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.) |
| Measure | Description | Time Frame |
|---|---|---|
| Central line associated bloodstream infections | Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011. | Throughout the study and from historical data |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore: Evanston Hospital | Recruiting | Evanston | Illinois | 60201 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 5, 2012 | |
| Reset | Dec 3, 2012 | |
| Release | Dec 29, 2017 | |
| Reset | Jan 26, 2018 | |
| Release | Sep 16, 2021 | |
| Reset | Oct 13, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 5, 2012 | Dec 3, 2012 | |||
| Dec 29, 2017 |
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| NorthShore: Glenbrook Hospital | Recruiting | Glenview | Illinois | 60201 | United States |
|
| NorthShore: Highland Park Hospital | Recruiting | Highland Park | Illinois | 60201 | United States |
|
| NorthShore: Skokie Hospital | Recruiting | Skokie | Illinois | 60201 | United States |
|
| Jan 26, 2018 |
| Sep 16, 2021 | Oct 13, 2021 |