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Quality Control: A Prospective Analysis of EVD Effectiveness

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02484287
Enrollment
60
Registered
2015-06-29
Start date
2016-04-30
Completion date
2018-07-12
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Infections

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.

Interventions

DEVICEThe 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.

DEVICEThe 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.

DEVICEThe 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

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients who require placement of external ventricular drain.

Exclusion criteria

* Prisoners and/or those who may be pregnant.

Design outcomes

Primary

MeasureTime frameDescription
Infection Rates of EVD Patients24 monthsInfection rates of EVD patients

Other

MeasureTime frameDescription
Duration of EVD Placement24 Monthsduration of EVD placement in days
Cost24 monthsComparable cost of each device

Countries

United States

Participant flow

Participants by arm

ArmCount
Ventriclear EVD Antibiotic Catheter
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter 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.
15
Integra External Drainage Catheter
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter 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.
26
Codman Bactiseal EVD Catheter Set
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter 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.
19
Total60

Baseline characteristics

CharacteristicVentriclear EVD Antibiotic CatheterIntegra External Drainage CatheterCodman Bactiseal EVD Catheter SetTotal
Age, Categorical
<=18 years
1 Participants0 Participants0 Participants1 Participants
Age, Categorical
>=65 years
5 Participants9 Participants7 Participants21 Participants
Age, Categorical
Between 18 and 65 years
9 Participants17 Participants12 Participants38 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants4 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants3 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants4 Participants
Race (NIH/OMB)
White
10 Participants21 Participants12 Participants43 Participants
Region of Enrollment
United States
15 participants26 participants19 participants60 participants
Sex: Female, Male
Female
10 Participants13 Participants8 Participants31 Participants
Sex: Female, Male
Male
5 Participants13 Participants11 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 150 / 19
other
Total, other adverse events
0 / 260 / 150 / 19
serious
Total, serious adverse events
0 / 260 / 150 / 19

Outcome results

Primary

Infection Rates of EVD Patients

Infection rates of EVD patients

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ventriclear EVD Antibiotic CatheterInfection Rates of EVD Patients0 Participants
Integra External Drainage CatheterInfection Rates of EVD Patients0 Participants
Codman Bactiseal EVD Catheter SetInfection Rates of EVD Patients0 Participants
Other Pre-specified

Cost

Comparable cost of each device

Time frame: 24 months

Population: This data was not collected and is no longer available.

Other Pre-specified

Duration of EVD Placement

duration of EVD placement in days

Time frame: 24 Months

ArmMeasureValue (MEAN)Dispersion
Ventriclear EVD Antibiotic CatheterDuration of EVD Placement11 daysStandard Deviation 7
Integra External Drainage CatheterDuration of EVD Placement13 daysStandard Deviation 10
Codman Bactiseal EVD Catheter SetDuration of EVD Placement10 daysStandard Deviation 5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026