Quality Control: A Prospective Analysis of EVD Effectiveness

University of Oklahoma (OU)

Status: Terminated

Conditions: Catheter Related Infections

Treatments: Device: The Ventriclear EVD Antibiotic Catheter; Device: The Integra External Drainage Catheter.; Device: The Codman Bactiseal EVD Catheter Set

Study type: Interventional

Funder types: Other

Identifiers

NCT02484287

4890

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who require placement of external ventricular drain.

Exclusion criteria

• Prisoners and/or those who may be pregnant.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

60 participants in 3 patient groups

Integra External Drainage Catheter

Active Comparator group

Description:

The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter

Treatment:

Device: The Integra External Drainage Catheter.

Ventriclear EVD Antibiotic Catheter

Active Comparator group

Description:

The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter

Treatment:

Device: The Ventriclear EVD Antibiotic Catheter

Codman Bactiseal EVD Catheter Set

Active Comparator group

Description:

The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter

Treatment:

Device: The Codman Bactiseal EVD Catheter Set