Quality Control: A Prospective Analysis of EVD Effectiveness

June 12, 2023 updated by: University of Oklahoma

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who require placement of external ventricular drain.

Exclusion Criteria:

  • Prisoners and/or those who may be pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Integra External Drainage Catheter
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter
Device: The Integra External Drainage Catheter.
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.
Active Comparator: Ventriclear EVD Antibiotic Catheter
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter
Device: The Ventriclear EVD Antibiotic Catheter
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.
Active Comparator: Codman Bactiseal EVD Catheter Set
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter
Device: The Codman Bactiseal EVD Catheter Set
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost comparison between 3 EVDs utilizing data received from billing
Time Frame: 24 months
Cost comparison between 3 EVDs utilizing data received from billing
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of EVD Placement
Time Frame: 24 Months
duration of EVD placement in days
24 Months
Cost
Time Frame: 24 months
Comparable cost of each device
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Ahmed A Cheema, MD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

July 12, 2018

Study Completion (Actual)

July 12, 2018

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimated)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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