Evaluating Central Line Hub Contamination Using a Novel Capping Device

Phase 1

• Conditions: Catheter-related Bloodstream Infection Due to Central Venous Catheter
• Interventions: Device: Disinfecting Cap

• Registration Number: NCT01301300
• Lead Sponsor: NorthShore University HealthSystem

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23
• Primary Completion: 2011-09
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glenbrook Hospital	Disinfecting Cap	Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.
Evanston, Highland Park, Skokie Hospitals	Disinfecting Cap	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)

Primary Outcome Measures

Name	Time	Method
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml	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.)	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.

Secondary Outcome Measures

Name	Time	Method
Central line associated bloodstream infections	Throughout the study and from historical data	Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011.

Trial Locations

Locations (4)

NorthShore: Highland Park Hospital; 🇺🇸 Highland Park, Illinois, United States

NorthShore: Skokie Hospital; 🇺🇸 Skokie, Illinois, United States

NorthShore: Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

NorthShore: Glenbrook Hospital; 🇺🇸 Glenview, Illinois, United States