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Quality Control: A Prospective Analysis of EVD Effectiveness

NCT02484287 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-03

Study results available
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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.

Conditions

  • Catheter Related Infections

Interventions

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.

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.

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Ahmed A Cheema, MD · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-07-12
Completion
2018-07-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484287 on ClinicalTrials.gov