Evaluating Central Line Hub Contamination Using a Novel Capping Device

NorthShore University HealthSystem

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Catheter-related Bloodstream Infection Due to Central Venous Catheter

Treatments: Device: Disinfecting Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT01301300

EH10-125

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Glenbrook Hospital

Active Comparator group

Description:

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

Treatment:

Device: Disinfecting Cap

Evanston, Highland Park, Skokie Hospitals

Active Comparator group

Description:

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)

Treatment:

Device: Disinfecting Cap