Catheter Related InfectionsNCT02484287
Quality Control: A Prospective Analysis of EVD Effectiveness
A study testing The Integra External Drainage Catheter., The Ventriclear EVD Antibiotic Catheter and The Codman Bactiseal EVD Catheter Set in people with Catheter Related Infections, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Catheter Related Infections
- What is being tested?
- The Integra External Drainage Catheter., The Ventriclear EVD Antibiotic Catheter and The Codman Bactiseal EVD Catheter Set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 12 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who require placement of external ventricular drain.
Who cannot join
- Prisoners and/or those who may be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness
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.
Read the 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
- Being tested
- The Integra External Drainage Catheter., The Ventriclear EVD Antibiotic Catheter, The Codman Bactiseal EVD Catheter Set
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Integra External Drainage Catheter.Device
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.
The Ventriclear EVD Antibiotic CatheterDevice
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.
The Codman Bactiseal EVD Catheter SetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Integra External Drainage Catheter | Active comparator | The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter Receives: Device: The Integra External Drainage Catheter. |
| Ventriclear EVD Antibiotic Catheter | Active comparator | The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter Receives: Device: The Ventriclear EVD Antibiotic Catheter |
| Codman Bactiseal EVD Catheter Set | Active comparator | The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter Receives: Device: The Codman Bactiseal EVD Catheter Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rates of EVD Patients
Infection rates of EVD patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startApr 2016
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Why it stopped: PI left institution prior to study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Catheter Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed A Cheema, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484287
- Sponsor's protocol ID
- 4890
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2015
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25541085Lane 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.
PubMed 25526265Kulwin 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.
PubMed 24679648Ziemba-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.
PubMed 24144595Cohen-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.
PubMed 24134085Bohnstedt 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.
PubMed 22465372
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness
- ClinicalTrials.gov ID
- NCT02484287
- Acronym / sponsor ID
- 4890
- Conditions
- Catheter Related Infections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution prior to study completion
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integra External Drainage Catheter | Active comparator | Device: The Integra External Drainage Catheter.The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter |
| Ventriclear EVD Antibiotic Catheter | Active comparator | Device: The Ventriclear EVD Antibiotic CatheterThe Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter |
| Codman Bactiseal EVD Catheter Set | Active comparator | Device: The Codman Bactiseal EVD Catheter SetThe Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who require placement of external ventricular drain.
Key exclusion criteria (1 listed)
- Prisoners and/or those who may be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Integra External Drainage Catheter |
| The Ventriclear EVD Antibiotic CatheterParticipants 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 | Ventriclear EVD Antibiotic Catheter |
| The Codman Bactiseal EVD Catheter SetParticipants 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 | Codman Bactiseal EVD Catheter Set |
Primary outcome
Infection Rates of EVD Patients
Time frame: 24 months
Infection rates of EVD patients
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25541085Bohnstedt 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.
- Background: PubMed 25526265Lane 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.
- Background: PubMed 24679648Kulwin 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.
- Background: PubMed 24144595Ziemba-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.
- Background: PubMed 24134085Cohen-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.
- Background: PubMed 22465372Bohnstedt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Cheema, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Integra External Drainage Catheter., The Ventriclear EVD Antibiotic Catheter and The Codman Bactiseal EVD Catheter Set in people with Catheter Related Infections, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection Rates of EVD Patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484287, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023; AzTrials last refreshed its copy on 28 Oct 2026.