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Clinical Trials/NCT01174992
NCT01174992CompletedPhase 2

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

Ethicon, Inc.24 sites in 6 countries139 target enrollmentStarted: July 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
139
Locations
24
Primary Endpoint
Proportion of success
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Proportion of success

Time Frame: Day 1 (intraoperative)

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (24)

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