Catheter Related Infections
Conditions
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
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.
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.
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
Study design
Eligibility
Inclusion criteria
* Patients who require placement of external ventricular drain.
Exclusion criteria
* Prisoners and/or those who may be pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rates of EVD Patients | 24 months | Infection rates of EVD patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of EVD Placement | 24 Months | duration of EVD placement in days |
| Cost | 24 months | Comparable cost of each device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 60 |
Baseline characteristics
| Characteristic | Ventriclear EVD Antibiotic Catheter | Integra External Drainage Catheter | Codman Bactiseal EVD Catheter Set | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 7 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 17 Participants | 12 Participants | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 10 Participants | 21 Participants | 12 Participants | 43 Participants |
| Region of Enrollment United States | 15 participants | 26 participants | 19 participants | 60 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 8 Participants | 31 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 11 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 15 | 0 / 19 |
| other Total, other adverse events | 0 / 26 | 0 / 15 | 0 / 19 |
| serious Total, serious adverse events | 0 / 26 | 0 / 15 | 0 / 19 |
Outcome results
Infection Rates of EVD Patients
Infection rates of EVD patients
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ventriclear EVD Antibiotic Catheter | Infection Rates of EVD Patients | 0 Participants |
| Integra External Drainage Catheter | Infection Rates of EVD Patients | 0 Participants |
| Codman Bactiseal EVD Catheter Set | Infection Rates of EVD Patients | 0 Participants |
Cost
Comparable cost of each device
Time frame: 24 months
Population: This data was not collected and is no longer available.
Duration of EVD Placement
duration of EVD placement in days
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventriclear EVD Antibiotic Catheter | Duration of EVD Placement | 11 days | Standard Deviation 7 |
| Integra External Drainage Catheter | Duration of EVD Placement | 13 days | Standard Deviation 10 |
| Codman Bactiseal EVD Catheter Set | Duration of EVD Placement | 10 days | Standard Deviation 5 |