Evaluating Central Line Hub Contamination Using a Novel Capping Device
NCT01301300 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2011-02-23
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.
Conditions
- Catheter-related Bloodstream Infection Due to Central Venous Catheter
Interventions
- DEVICE
-
Disinfecting Cap
Replace standard practice with using the disinfecting cap
Sponsors & Collaborators
-
Endeavor Health
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2011-09-30
- Completion
- 2011-12-31
Countries
- United States
Study Locations
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