Evaluating Central Line Hub Contamination Using a Novel Capping Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Catheter-related Bloodstream Infection Due to Central Venous Catheter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Glenbrook Hospital

Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.

Group Type ACTIVE_COMPARATOR

Disinfecting Cap

Intervention Type DEVICE

Replace standard practice with using the disinfecting cap

Evanston, Highland Park, Skokie Hospitals

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)

Group Type ACTIVE_COMPARATOR

Disinfecting Cap

Intervention Type DEVICE

Replace standard practice with using the disinfecting cap

Interventions

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Disinfecting Cap

Replace standard practice with using the disinfecting cap

Intervention Type DEVICE

Other Intervention Names

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SwabCap SC003 2000

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.