Trial · NCT00197392

Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

NCT00197392, Phase 4, Completed, Codman & Shurtleff; results first posted 2013-11-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System. Trials, record NCT00197392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00197392

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
NCT number: NCT00197392
Status: Completed
Phases: Phase 4
Enrollment: 434 participants, actual
Lead sponsor: Codman & Shurtleff
Conditions: Intraventricular Hemorrhage, Subarachnoid Hemorrhage
Interventions: Bactiseal TM EVD, Standard EVD Catheter
First posted: 2005-09-20
Last updated: 2013-11-05
Results first posted: 2013-11-05

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Infections	Duration of implanted EVD system to 2 week post implant	The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).
Secondary	Days to Proven Infection	Implantation of EVD System to explant of EVD catheter, an average of ten days	Number of days to proven infection.
Secondary	Class of Bacterial Agent Causing Proven Infection	Implantation of subject to post implant	Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD
Secondary	Intraluminal Colonization on Catheters	Implant of subjects to post implant	Number of catheters with Bacterial colonization verified using fluorescence.
Secondary	Device Related Adverse Events	Implanted subjects to time of explant	Number of Device Related Adverse Events
Secondary	Number of Days With Indwelling Catheter	Implant of subjects to day of explant	Days catheter was implanted in subjects
Secondary	Average Subject Age	Implant to subject	The average subject age
Secondary	Diagnosis Requiring EVD Implantation	Implantation of EVD system	Primary diagnosis for implantation of EVD system
Secondary	Non-infectious Catheter Failure in the MITT Population	Implant of subject to explant	Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.
Secondary	Time Point of Introduction of Systemic Antibiotic Therapy	Within 48 hours of implant of subjects to explant	Time points of then patients received systemic antibiotic therapy

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Infections	Duration of implanted EVD system to 2 week post implant		Infections	NUMBER
SECONDARY	Days to Proven Infection	Implantation of EVD System to explant of EVD catheter, an average of ten days		Days	MEAN
SECONDARY	Class of Bacterial Agent Causing Proven Infection	Implantation of subject to post implant	All subjects included in the MITT, Evaluable and Per-Protocol population.	participants	NUMBER
SECONDARY	Intraluminal Colonization on Catheters	Implant of subjects to post implant		catheters	NUMBER
SECONDARY	Device Related Adverse Events	Implanted subjects to time of explant	There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.	events	NUMBER
SECONDARY	Number of Days With Indwelling Catheter	Implant of subjects to day of explant		Days	MEAN
SECONDARY	Average Subject Age	Implant to subject		Years	MEAN
SECONDARY	Diagnosis Requiring EVD Implantation	Implantation of EVD system	Analysis consisted of combining both Arm/Group (Bactiseal and Standard)	Participants	NUMBER
SECONDARY	Non-infectious Catheter Failure in the MITT Population	Implant of subject to explant		Participants	NUMBER
SECONDARY	Time Point of Introduction of Systemic Antibiotic Therapy	Within 48 hours of implant of subjects to explant		Paticipants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group95

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Infections	Bactiseal EVD Catheter	Modified intent to Treat	4		Infections
Number of Infections	Standard EVD Cathter	Modified intent to Treat	5		Infections
Number of Infections	Bactiseal EVD Catheter	Evaluable	4		Infections
Number of Infections	Standard EVD Cathter	Evaluable	5		Infections
Number of Infections	Bactiseal EVD Catheter	Per Protocol	1		Infections
Number of Infections	Standard EVD Cathter	Per Protocol	3		Infections
Days to Proven Infection	Bactiseal EVD Catheter	Modified Intent to Treat	9.5	Standard Deviation 3.3	Days
Days to Proven Infection	Standard EVD Catheter	Modified Intent to Treat	10	Standard Deviation 3.0	Days
Days to Proven Infection	Bactiseal EVD Catheter	Evaluable	9.5	Standard Deviation 3.3	Days
Days to Proven Infection	Standard EVD Catheter	Evaluable	10	Standard Deviation 3.0	Days

1 to 10 of 95Source ClinicalTrials.gov

See all 95 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bactiseal EVD	214
Overall Study	STARTED	Conventional EVD Catheter	220
Overall Study	Safety Population	Bactiseal EVD	214
Overall Study	Safety Population	Conventional EVD Catheter	220
Overall Study	Modified Intent to Treat	Bactiseal EVD	209
Overall Study	Modified Intent to Treat	Conventional EVD Catheter	210
Overall Study	Evaluable	Bactiseal EVD	176
Overall Study	Evaluable	Conventional EVD Catheter	181
Overall Study	Per Protocol	Bactiseal EVD	126
Overall Study	Per Protocol	Conventional EVD Catheter	134

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Blood positive for streptococcus	Infections and infestations	Standard EVD	0	220	0
other	Blood positive for streptococcus	Infections and infestations	Bactiseal EVD	1	214	1
other	CNS Infection	Infections and infestations	Standard EVD	2	220	2
other	CNS Infection	Infections and infestations	Bactiseal EVD	4	214	4
other	Coagulase negative staphylococcus in CSF	Infections and infestations	Standard EVD	1	220	1
other	Coagulase negative staphylococcus in CSF	Infections and infestations	Bactiseal EVD	1	214	1
other	Confirmed dipthroid infection in CSF	Infections and infestations	Standard EVD	1	220	1
other	Confirmed dipthroid infection in CSF	Infections and infestations	Bactiseal EVD	0	214	0
other	CSF culture positive for coagulase negative staphylococcus	Infections and infestations	Standard EVD	1	220	1
other	CSF culture positive for coagulase negative staphylococcus	Infections and infestations	Bactiseal EVD	0	214	0

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard EVD
Total, all-cause mortality	Bactiseal EVD
Total, other adverse events	Standard EVD	11	220
Total, other adverse events	Bactiseal EVD	19	214
Total, serious adverse events	Standard EVD	16	220
Total, serious adverse events	Bactiseal EVD	14	214

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
2732730	BACKGROUND	PubMed
7841297	BACKGROUND	PubMed
9254088	BACKGROUND	PubMed
12182415	BACKGROUND	PubMed
12691395	BACKGROUND	PubMed
14609161	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Standard EVD vs Bactiseal EVD: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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