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Device

Clear Bactiseal 'large' catheter (EVD) for Blockage

N/A
Waitlist Available
Led By Kyle M Fargen, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours after placement.
Awards & highlights

Study Summary

This trial will compare the rates of occlusion and need for replacement for small vs. large EVD catheters, to see if there is a difference in risk based on catheter size.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours after placement.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after placement. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Permanent Catheter Occlusions
Secondary outcome measures
Number of Participants With Catheter Replacements
Number of Participants With Procedure-related Hemorrhages
Number of Participants With Symptomatic Hemorrhages
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Clear Bactiseal 'large' catheter (EVD)Active Control1 Intervention
All EVDs will be placed by neurological surgeons in either the major operating suite or in an ICU setting using a previously published protocol. This protocol includes using a burr hole entry point 1 cm anterior to the coronal suture in the mid-pupillary line, prep and sterile drape, pre-procedural antibiotic administration, and tunneling the catheter to an exit site at least 5 cm from the incision. In general, physicians are instructed to first attempt distal irrigation of the drainage chamber using sterile techniques (rarely effective), followed by gentle aspiration of the proximal system and catheter if distal flushing is not effective. If these do not restore patency, a small volume of sterile saline, 3 ml or less, is flushed proximally into the catheter. Patency is checked by lowering the EVD drainage system and evaluating for spontaneous flow through the EVD.
Group II: Orange Bactiseal 'small' catheter (EVD)Active Control1 Intervention
All EVDs will be placed by neurological surgeons in either the major operating suite or in an ICU setting using a previously published protocol. This protocol includes using a burr hole entry point 1 cm anterior to the coronal suture in the mid-pupillary line, prep and sterile drape, pre-procedural antibiotic administration, and tunneling the catheter to an exit site at least 5 cm from the incision. In general, physicians are instructed to first attempt distal irrigation of the drainage chamber using sterile techniques (rarely effective), followed by gentle aspiration of the proximal system and catheter if distal flushing is not effective. If these do not restore patency, a small volume of sterile saline, 3 ml or less, is flushed proximally into the catheter. Patency is checked by lowering the EVD drainage system and evaluating for spontaneous flow through the EVD.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,145 Total Patients Enrolled
Kyle M Fargen, MDPrincipal InvestigatorAssistant Professor, Surgery Neurosurgery
~4 spots leftby Jun 2025
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