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Evaluating Central Line Hub Contamination Using a Novel Capping Device

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ClinicalTrials.gov Identifier: NCT01301300
Recruitment Status : Unknown
Verified February 2011 by NorthShore University HealthSystem Research Institute.
Recruitment status was:  Recruiting
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
NorthShore University HealthSystem Research Institute

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.


Condition or disease Intervention/treatment Phase
Catheter-related Bloodstream Infection Due to Central Venous Catheter Device: Disinfecting Cap Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device
Study Start Date : April 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: Glenbrook Hospital
Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.
Device: Disinfecting Cap
Replace standard practice with using the disinfecting cap
Other Name: SwabCap SC003 2000
Active Comparator: 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)

Device: Disinfecting Cap
Replace standard practice with using the disinfecting cap
Other Name: SwabCap SC003 2000



Primary Outcome Measures :
  1. Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml [ 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.) ]

    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 :
  1. Central line associated bloodstream infections [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301300


Locations
United States, Illinois
NorthShore: Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Sue Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420    mwright@northshore.org   
NorthShore: Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60201
Contact: Sue Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420    mwright@northshore.org   
NorthShore: Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60201
Contact: Sue Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420    mwright@northshore.org   
NorthShore: Skokie Hospital Recruiting
Skokie, Illinois, United States, 60201
Contact: Sue ` Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420      
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute

Responsible Party: Lance R Peterson, Associate Hospital Epidemiologist, NorthShore University Health System
ClinicalTrials.gov Identifier: NCT01301300     History of Changes
Other Study ID Numbers: EH10-125
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011