NCT02484287

Quality Control: A Prospective Analysis of EVD Effectiveness

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Catheter Related Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-07-12
• Completion: 2018-07-12
• First posted: 2015-06-29
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

1 site across 1 country: United States