Evaluating Central Line Hub Contamination Using a Novel Capping Device

Study Overview
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Brief Summary
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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.

Official Title
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Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device

Conditions
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Catheter-related Bloodstream Infection Due to Central Venous Catheter

Intervention / Treatment
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* Device: Disinfecting Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled. Exclusion Criteria: Minors and adult inpatients without PICCs or with PICCs for < 5 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glenbrook Hospital<br>Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only. | Device: Disinfecting Cap<br>* Replace standard practice with using the disinfecting cap<br>* Other names: SwabCap SC003 2000;|
| Active Comparator: Evanston, Highland Park, Skokie Hospitals<br>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) | Device: Disinfecting Cap<br>* Replace standard practice with using the disinfecting cap<br>* Other names: SwabCap SC003 2000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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.) | 

Secondary Outcome Measures

| Outcome Measure | 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 |