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Quality Control: A Prospective Analysis of EVD Effectiveness

Primary Purpose

Catheter Related Infections

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Integra External Drainage Catheter.
The Ventriclear EVD Antibiotic Catheter
The Codman Bactiseal EVD Catheter Set
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Catheter Related Infections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who require placement of external ventricular drain.

Exclusion Criteria:

  • Prisoners and/or those who may be pregnant.

Sites / Locations

  • Oklahoma University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Integra External Drainage Catheter

Ventriclear EVD Antibiotic Catheter

Codman Bactiseal EVD Catheter Set

Arm Description

The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter

The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter

The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter

Outcomes

Primary Outcome Measures

Infection Rates of EVD Patients
Infection rates of EVD patients

Secondary Outcome Measures

Full Information

First Posted
June 23, 2015
Last Updated
June 12, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT02484287
Brief Title
Quality Control: A Prospective Analysis of EVD Effectiveness
Official Title
Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left institution prior to study completion
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integra External Drainage Catheter
Arm Type
Active Comparator
Arm Description
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter
Arm Title
Ventriclear EVD Antibiotic Catheter
Arm Type
Active Comparator
Arm Description
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter
Arm Title
Codman Bactiseal EVD Catheter Set
Arm Type
Active Comparator
Arm Description
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter
Intervention Type
Device
Intervention Name(s)
The Integra External Drainage Catheter.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The Ventriclear EVD Antibiotic Catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The Codman Bactiseal EVD Catheter Set
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infection Rates of EVD Patients
Description
Infection rates of EVD patients
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Duration of EVD Placement
Description
duration of EVD placement in days
Time Frame
24 Months
Title
Cost
Description
Comparable cost of each device
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who require placement of external ventricular drain. Exclusion Criteria: Prisoners and/or those who may be pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Cheema, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25541085
Citation
Bohnstedt BN, Ziemba-Davis M, Edwards G, Brom J, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Palmer E, Cohen-Gadol AA. Treatment and outcomes among 102 posterior inferior cerebellar artery aneurysms: a comparison of endovascular and microsurgical clip ligation. World Neurosurg. 2015 May;83(5):784-93. doi: 10.1016/j.wneu.2014.12.035. Epub 2014 Dec 23.
Results Reference
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PubMed Identifier
25526265
Citation
Lane B, Bohnstedt BN, Cohen-Gadol AA. A prospective comparative study of microscope-integrated intraoperative fluorescein and indocyanine videoangiography for clip ligation of complex cerebral aneurysms. J Neurosurg. 2015 Mar;122(3):618-26. doi: 10.3171/2014.10.JNS132766. Epub 2014 Dec 19.
Results Reference
background
PubMed Identifier
24679648
Citation
Kulwin C, Bohnstedt BN, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Cohen-Gadol AA. Aneurysmal acute subdural hemorrhage: prognostic factors associated with treatment. J Clin Neurosci. 2014 Aug;21(8):1333-6. doi: 10.1016/j.jocn.2013.12.010. Epub 2014 Jan 24.
Results Reference
background
PubMed Identifier
24144595
Citation
Ziemba-Davis M, Bohnstedt BN, Payner TD, Leipzig TJ, Palmer E, Cohen-Gadol AA. Incidence, epidemiology, and treatment of aneurysmal subarachnoid hemorrhage in 12 midwest communities. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1073-82. doi: 10.1016/j.jstrokecerebrovasdis.2013.09.010. Epub 2013 Oct 19.
Results Reference
background
PubMed Identifier
24134085
Citation
Cohen-Gadol AA, Bohnstedt BN. Recognition and evaluation of nontraumatic subarachnoid hemorrhage and ruptured cerebral aneurysm. Am Fam Physician. 2013 Oct 1;88(7):451-6.
Results Reference
background
PubMed Identifier
22465372
Citation
Bohnstedt BN, Nguyen HS, Kulwin CG, Shoja MM, Helbig GM, Leipzig TJ, Payner TD, Cohen-Gadol AA. Outcomes for clip ligation and hematoma evacuation associated with 102 patients with ruptured middle cerebral artery aneurysms. World Neurosurg. 2013 Sep-Oct;80(3-4):335-41. doi: 10.1016/j.wneu.2012.03.008. Epub 2012 Mar 30.
Results Reference
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Quality Control: A Prospective Analysis of EVD Effectiveness

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