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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01174992

Enrollment

139

Registered

2010-08-04

Start date

2010-07-31

Completion date

2011-10-31

Last updated

2012-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dura Defects

Keywords

Fibrin sealant, CSF leak

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.

Interventions

BIOLOGICALEvicel

EVICEL is a human plasma derived fibrin sealant

OTHERSutures only

Standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of success	Day 1 (intraoperative)	Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.

Secondary

Measure	Time frame
Incidence of CSF leakage	Day 5 post-op
Incidence of adverse events	up to 30 days post-op
Incidence of surgical site infections	Day 5 and 30 post-op

Countries

Belgium, Finland, France, Germany, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026