MedTrace Logo

A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

NCT01174992 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2012-06-20

No results posted yet for this study

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.

Conditions

  • Dura Defects

Interventions

BIOLOGICAL

Evicel

EVICEL is a human plasma derived fibrin sealant

OTHER

Sutures only

Standard of care

Sponsors & Collaborators

  • OMRIX Biopharmaceuticals

    collaborator INDUSTRY

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • James Hart, MD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Belgium
  • Finland
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01174992 on ClinicalTrials.gov