Clinical trial NCT01174992: A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dura Defects
Keywords: Fibrin sealant
CSF leak
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OMRIX Biopharmaceuticals
First posted: 2010-08-04
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Proportion of success
timeFrame: Day 1 (intraoperative)
Secondary outcomes:
measure: Incidence of CSF leakage
timeFrame: Day 5 post-op
measure: Incidence of CSF leakage
timeFrame: Day 30 post-op
measure: Incidence of adverse events
timeFrame: up to 30 days post-op
measure: Incidence of surgical site infections
timeFrame: Day 5 and 30 post-op
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Department of Neurosurgery, Ziekenhuis Oost Limburg
city: Liège
country: Belgium
facility: Department of Neurosurgery, University Hospital of Liège
city: Tampere
country: Finland
facility: Department of Neurosciences and Rehabilitation, Tampere University Hospital
city: Cedex
country: France
facility: Service de Neurochirurgie B, Hopital Neurologique de Lyon
city: Essen
country: Germany
facility: Klinik für Neurochirurgie, Universitätsklinikum Essen
city: Giessen
country: Germany
facility: Department of Neurosurgery, University Giessen-Marburg
city: Ingolstadt
country: Germany
facility: Department of Neurosurgery, Klinikum Ingolstadt GmbH
city: Kiel
country: Germany
facility: Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel
city: Amsterdam
country: Netherlands
facility: VU Medical Centre
city: Headington
country: United Kingdom
facility: Department of Neurosurgery, John Radcliffe Hospital
state: Oxford
city: Dundee
country: United Kingdom
facility: Department of Neurosurgery, Ninewells Hospital & Medical School
city: Edinburgh
country: United Kingdom
facility: Edinburgh Centre for Neuro-Oncology, Western General Hospital
Study officials:
affiliation: Ethicon, Inc.
name: James Hart, MD
role: STUDY_DIRECTOR
References: