Quality Control: A Prospective Analysis of EVD Effectiveness

Not Applicable

Terminated

• Conditions: Catheter Related Infections
• Interventions: Device: The Codman Bactiseal EVD Catheter Set; Device: The Ventriclear EVD Antibiotic Catheter; Device: The Integra External Drainage Catheter.

• Registration Number: NCT02484287
• Lead Sponsor: University of Oklahoma

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Study Start: 2016-04
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Results First Submitted: 2021-11-04
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Results First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who require placement of external ventricular drain.

Exclusion Criteria

• Prisoners and/or those who may be pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Codman Bactiseal EVD Catheter Set	The Codman Bactiseal EVD Catheter Set	The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter
Ventriclear EVD Antibiotic Catheter	The Ventriclear EVD Antibiotic Catheter	The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter
Integra External Drainage Catheter	The Integra External Drainage Catheter.	The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter

Primary Outcome Measures

Name	Time	Method
Infection Rates of EVD Patients	24 months	Infection rates of EVD patients

Trial Locations

Locations (1)

Oklahoma University Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States