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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dura Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Evicel

Group Type EXPERIMENTAL

Evicel

Intervention Type BIOLOGICAL

EVICEL is a human plasma derived fibrin sealant

Sutures only

Group Type OTHER

Sutures only

Intervention Type OTHER

Standard of care

Interventions

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Evicel

EVICEL is a human plasma derived fibrin sealant

Intervention Type BIOLOGICAL

Sutures only

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No