Hub Cleansing to Prevent Hub Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hub Cleansing to Prevent Hub Infection

Conditions
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Bacteremia

Intervention / Treatment
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* Other: 15 second scrub
* Other: 5 second scrub
* Drug: 3.15% chlorhexidine/70% isopropyl alcohol
* Drug: 70% isopropyl alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical intensive care unit patients with non-tunneled central venous catheters Exclusion Criteria: Dialysis catheters Antibiotic-impregnated catheters Introducer sheaths Tunneled catheters

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol with 5 second scrub<br>70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. | Other: 5 second scrub<br>* Scrub catheter hubs for 15 seconds before every access.<br>Drug: 70% isopropyl alcohol<br>* 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.<br>* Other names: Professional Disposable International Inc Alcohol Prep Pad;|
| Experimental: Alcohol with 15 second scrub<br>70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. | Other: 15 second scrub<br>* Scrub catheter hubs for 15 seconds before every access.<br>Drug: 70% isopropyl alcohol<br>* 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.<br>* Other names: Professional Disposable International Inc Alcohol Prep Pad;|
| Experimental: Chlorhexidine with 5 second scrub<br>3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. | Other: 5 second scrub<br>* Scrub catheter hubs for 15 seconds before every access.<br>Drug: 3.15% chlorhexidine/70% isopropyl alcohol<br>* 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.<br>* Other names: Professional Disposables International Inc. Chlorascrub Swab;|
| Experimental: Chlorhexidine with 15 second scrub<br>3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. | Other: 15 second scrub<br>* Scrub catheter hubs for 15 seconds before every access.<br>Drug: 3.15% chlorhexidine/70% isopropyl alcohol<br>* 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.<br>* Other names: Professional Disposables International Inc. Chlorascrub Swab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Central Venous Catheter Hubs With Internal Contamination | This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Contaminated Central Venous Catheter Tips | This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no. | 10 months | 
| Median Number of Microbial Colony Forming Units Per Hub Interior | This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Needleless connectors, catheter hubs