NCT01174992

Brief Summary

The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_2

Geographic Reach
6 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

August 3, 2010

Last Update Submit

June 19, 2012

Conditions

Dura Defects

Keywords

Fibrin sealantCSF leak

Outcome Measures

Primary Outcomes (1)

  • Proportion of success

    Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.

    Day 1 (intraoperative)

Secondary Outcomes (4)

  • Incidence of CSF leakage

    Day 5 post-op

  • Incidence of CSF leakage

    Day 30 post-op

  • Incidence of adverse events

    up to 30 days post-op

  • Incidence of surgical site infections

    Day 5 and 30 post-op

Study Arms (2)

Evicel

EXPERIMENTAL
Biological: Evicel

Sutures only

OTHER
Other: Sutures only

Interventions

EvicelBIOLOGICAL

EVICEL is a human plasma derived fibrin sealant

Evicel
Sutures onlyOTHER

Standard of care

Sutures only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing elective craniotomy/craniectomy
  • Age greater than or equal to 18 years
  • Patients who are able and willing to comply with the procedures required by the protocol.
  • Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.

You may not qualify if:

  • Chemotherapy or radiation therapy within 7 days following surgery.
  • Conditions compromising the immune system.
  • Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
  • Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
  • Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
  • Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.
  • Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Department of Neurosurgery, Ziekenhuis Oost Limburg

Genk, B-3600, Belgium

Location

Department of Neurosurgery, University Hospital of Liège

Liège, B-4000, Belgium

Location

Department of Neurosciences and Rehabilitation, Tampere University Hospital

Tampere, FI-33521, Finland

Location

Service de Neurochirurgie B, Hopital Neurologique de Lyon

Cedex, 696 BRON, France

Location

Klinik für Neurochirurgie, Universitätsklinikum Essen

Essen, D-45122, Germany

Location

Department of Neurosurgery, University Giessen-Marburg

Giessen, 35385, Germany

Location

Department of Neurosurgery, Klinikum Ingolstadt GmbH

Ingolstadt, 85049, Germany

Location

Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel

Kiel, D-24105, Germany

Location

VU Medical Centre

Amsterdam, 1081 HV, Netherlands

Location

Department of Neurosurgery, John Radcliffe Hospital

Headington, Oxford, OX3 9DU, United Kingdom

Location

Department of Neurosurgery, Ninewells Hospital & Medical School

Dundee, DD1 9SY, United Kingdom

Location

Edinburgh Centre for Neuro-Oncology, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid LeakNeurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • James Hart, MD

    Ethicon, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 4, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

DE(4)FI(1)NL(1)FR(1)GB(3)BE(2)