Evaluating Central Line Hub Contamination Using a Novel Capping Device
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Catheter-related Bloodstream Infection Due to Central Venous Catheter |
Device: Disinfecting Cap |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device |
- 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.) ] [ Designated as safety issue: No ]
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Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.
- Central line associated bloodstream infections [ Time Frame: Throughout the study and from historical data ] [ Designated as safety issue: No ]Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011.
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and 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 | |
More Information
No publications provided
| 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 |
| Study First Received: | February 22, 2011 |
| Last Updated: | February 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013