Hub Cleansing to Prevent Hub Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | June 2013 |
Central venous catheter infections are common preventable adverse events among hospital
patients. Microbes may enter catheter hubs, also known as needleless connectors, and result
in downstream contamination. This study aims to compare alcohol disinfection of catheter
hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a
superior disinfectant at the site of central venous catheter insertion. Scrub duration of
central venous catheter hubs will also be evaluated.
patients. Microbes may enter catheter hubs, also known as needleless connectors, and result
in downstream contamination. This study aims to compare alcohol disinfection of catheter
hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a
superior disinfectant at the site of central venous catheter insertion. Scrub duration of
central venous catheter hubs will also be evaluated.
A prospective randomized blinded crossover clinical trial will be performed in the medical
intensive care unit at Rush University Medical Center. The intensive care unit will be
divided into two regions (A&B). Hub disinfectants and duration of disinfection will be
randomly assigned to these regions. After 1/2 of the study period, the agents will
crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2
factorial design. Our primary endpoint will be internal contamination of hubs and catheters.
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.
intensive care unit at Rush University Medical Center. The intensive care unit will be
divided into two regions (A&B). Hub disinfectants and duration of disinfection will be
randomly assigned to these regions. After 1/2 of the study period, the agents will
crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2
factorial design. Our primary endpoint will be internal contamination of hubs and catheters.
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.
Inclusion Criteria:
- Medical intensive care unit patients with non-tunneled central venous catheters
Exclusion Criteria:
- Dialysis catheters
- Antibiotic-impregnated catheters
- Introducer sheaths
- Tunneled catheters
We found this trial at
1
site
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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