Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
149 participants
INTERVENTIONAL
2012-03-31
2013-06-30
Brief Summary
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Detailed Description
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In February 2012 it was determined that the supplier of chlorhexidine and alcohol pads could not completely blind each pad. It was decided that a plain white sticker would be affixed to the front of each pad, but the safety information on the back of each pad would remain visible.
3/27/12-Internal hub contamination (yes/no)was clarified as the primary outcome.
On 5/10/12 a new sample size calculation adjusted the hub sample size needed to power the main effects based on more accurate information regarding the expected hub contamination rate. The expected hub contamination rate changed because of the more sensitive hub culture method that was adopted before the study began. This more sensitive method also allowed for a new secondary outcome of number of microbial colony forming units per hub.
The first crossover time selected was 6/11/12, prior to the midpoint of the study. This was done to try to improve a large imbalance in the group sizes.
On 6/11/12 a hold was placed on the catheter tip component of the study, because of an inability to collect tips.
On 8/7/12 the catheter tip outcome was dropped because of an inability to collect tips.
On 1/11/13 a second crossover was implemented in an effort to balance the sizes of the study groups.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Alcohol with 5 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
5 second scrub
Scrub catheter hubs for 15 seconds before every access.
70% isopropyl alcohol
70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.
Alcohol with 15 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
15 second scrub
Scrub catheter hubs for 15 seconds before every access.
70% isopropyl alcohol
70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.
Chlorhexidine with 5 second scrub
3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
5 second scrub
Scrub catheter hubs for 15 seconds before every access.
3.15% chlorhexidine/70% isopropyl alcohol
3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.
Chlorhexidine with 15 second scrub
3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
15 second scrub
Scrub catheter hubs for 15 seconds before every access.
3.15% chlorhexidine/70% isopropyl alcohol
3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.
Interventions
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15 second scrub
Scrub catheter hubs for 15 seconds before every access.
5 second scrub
Scrub catheter hubs for 15 seconds before every access.
3.15% chlorhexidine/70% isopropyl alcohol
3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.
70% isopropyl alcohol
70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Antibiotic-impregnated catheters
* Introducer sheaths
* Tunneled catheters
16 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Rush University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Mary K Hayden, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Robert A Weinstein, MD
Role: PRINCIPAL_INVESTIGATOR
Cook County Health and Hospital Systems
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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