Evaluating Central Line Hub Contamination Using a Novel Capping Device

February 22, 2011 updated by: NorthShore University HealthSystem

Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
      • Glenview, Illinois, United States, 60201
      • Highland Park, Illinois, United States, 60201
      • Skokie, Illinois, United States, 60201
        • Recruiting
        • NorthShore: Skokie Hospital
        • Contact:
        • Contact:
          • Marc Wright, MS
          • Phone Number: 8475702420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • SwabCap SC003 2000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout the study and from historical data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH10-125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Catheter-related Bloodstream Infection Due to Central Venous Catheter

Clinical Trials on Disinfecting Cap

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe