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

Ethicon

Status and phase

Completed

Phase 3

Phase 2

Conditions

Dura Defects

Treatments

Biological: Evicel

Other: Sutures only

Study type

Interventional

Funder types

Industry

Identifiers

NCT01174992

400-09-001

2009-016501-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.