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

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.

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

Conditions
-----------------
Dura Defects

Intervention / Treatment
-----------------
* Biological: Evicel
* Other: Sutures only


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evicel<br> | Biological: Evicel<br>* EVICEL is a human plasma derived fibrin sealant<br>|
| Other: Sutures only<br> | Other: Sutures only<br>* Standard of care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of success | Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage. | Day 1 (intraoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CSF leakage |  | Day 5 post-op | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibrin sealant, CSF leak