Phase 4
N=434
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Intraventricular Hemorrhage · Subarachnoid Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00197392 ↗Enrolled (actual)
434
Serious AEs
6.9%
Results posted
Nov 2013
Primary outcome: Primary: Number of Infections — 4; 5; 4; 5 Infections
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bactiseal TM EVD (Device); Standard EVD Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Codman & Shurtleff
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infections |
4; 5; 4; 5; 1; 3 | — |
| SECONDARY Days to Proven Infection |
9.5; 10; 9.5; 10; 14; 10 | — |
| SECONDARY Class of Bacterial Agent Causing Proven Infection |
11; 0; 0; 6 | — |
| SECONDARY Intraluminal Colonization on Catheters |
0; 3 | — |
| SECONDARY Device Related Adverse Events |
0; 1; 1; 4; 0; 0 | — |
| SECONDARY Number of Days With Indwelling Catheter |
8.7; 8.9; 9.3; 9.7; 9.8; 10.4 | — |
| SECONDARY Average Subject Age |
51.9; 54.4; 51.9; 54.5; 49.4; 54.2 | — |
| SECONDARY Diagnosis Requiring EVD Implantation |
20; 17; 13; 335; 282; 197 | — |
| SECONDARY Non-infectious Catheter Failure in the MITT Population |
16; 0; 0; 1; 0; 1 | — |
| SECONDARY Time Point of Introduction of Systemic Antibiotic Therapy |
146; 149; 167; 175; 118; 124 | — |
| SECONDARY Hospital Locations for EVD Catheter Placement |
45; 49; 159; 153; 37; 41 | — |
| SECONDARY Length of Catheter Tunneling Into the Brain |
6.2; 5.8; 6.2; 5.8; 6.0; 5.7 | — |
| SECONDARY Number of Catheter Insertion Attempts |
177; 178; 15; 16; 9; 11 | — |
Summary
The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study
Eligibility Criteria
Inclusion Criteria
- The Subject is 18 years or older.
- The Subject (family member/legal representative) has given written Informed Consent prior to enrollment into this trial OR, where the Subject is unable to consent and no relative/legal representative is available to offer consent, appropriate legal and ethical practices are employed and thoroughly documented according to the laws and policies of the respective country and institution.
- The Subject (family member/legal representative) is willing to participate in this trial for the duration of the implanted EVD system and is willing to comply with the protocol requirements.
Exclusion Criteria
- Within the preceding 30 days, the Subject has enrolled or participated in another trial utilizing an anti-microbial drug or medical device implanted in or directly influencing the CNS and/or spinal cord.
- The Subject is pregnant or lactating.
- The Subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin.
- The Subject has a positive CSF culture prior to EVD implant.
- The Subject is immunocompromised.
- The Subject requires more than one ventricular catheter concurrently.
- The Subject has had an EVD catheter within the previous 30 days.
- The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, an ear infection on either side, or a severe respiratory tract infection that, in the opinion of the Investigator, would most likely compromise the effectiveness of the EVD system.
- The Subject is known to have received systemic antibiotic therapy within a 14-day period preceding screening for inclusion in this trial.
- The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this trial.
- The Subject is a prisoner.
Data sourced from ClinicalTrials.gov (NCT00197392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.