Evaluating Central Line Hub Contamination Using a Novel Capping Device

Endeavor Health600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

NorthShore: Evanston Hospital

Evanston, Illinois, United States

RECRUITING

NorthShore: Glenbrook Hospital

Glenview, Illinois, United States

RECRUITING

NorthShore: Highland Park Hospital

Highland Park, Illinois, United States

RECRUITING

NorthShore: Skokie Hospital

Skokie, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.

Time frame: 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 Outcomes

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.

Time frame: Throughout the study and from historical data