Quality Control: A Prospective Analysis of EVD Effectiveness

Study Overview
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Brief Summary
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The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD) related catheter infections by comparing the efficacy of Oklahoma University Medicine standard EVD catheters, both impregnated and non-impregnated, in three principle areas: incidence of infection, cost analysis, and average durations of placement, all while maintaining the standards of technique.

Detailed Description
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Experimental design: Track external ventricular drain (EVD) associated infections and through quality prospective analysis and compare the usage of standard catheters used by the department here at Oklahoma University, 1) the 35cm Codman Bactiseal rifampin and clindamycin impregnated catheter, 2) the Ventriclear EVD Antibiotic Catheter, and 3) the 36 cm Integra Hermatic large style ventricular catheter, in terms of incidence of infections, cost, duration of placement, and differences in placement technique. Proposed procedure: Monitor for infections associated with and related to EVD placement in patients and assess if infections rates are affected by usage of antibiotic impregnated EVD catheters. Importance of knowledge reasonably expected to result from the research: While use of sterile techniques and periprocedural antibiotics have traditionally been used to combat infection, infection rates remain above goal leading to the question of whether the antibiotic impregnated catheter should be added to the standard of care. With the knowledge gained, the investigators hope to decrease the amount of external ventricular drain related catheter infections and reduce use of prolonged antibiotics.

Official Title
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Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness

Conditions
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Catheter Related Infections

Intervention / Treatment
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* Device: The Integra External Drainage Catheter.
* Device: The Ventriclear EVD Antibiotic Catheter
* Device: The Codman Bactiseal EVD Catheter Set


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who require placement of external ventricular drain. Exclusion Criteria: Prisoners and/or those who may be pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integra External Drainage Catheter<br>The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter | Device: The Integra External Drainage Catheter.<br>* Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.<br>|
| Active Comparator: Ventriclear EVD Antibiotic Catheter<br>The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter | Device: The Ventriclear EVD Antibiotic Catheter<br>* Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.<br>|
| Active Comparator: Codman Bactiseal EVD Catheter Set<br>The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter | Device: The Codman Bactiseal EVD Catheter Set<br>* Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rates of EVD Patients | Infection rates of EVD patients | 24 months |