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

Dura Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174992
• Other study ID #: 400-09-001
• Secondary ID: 2009-016501-41
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 3, 2010
• Last updated: June 19, 2012
• Start date: July 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-InstitutNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Finland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dura Defects

Intervention

Biological:
• Evicel
EVICEL is a human plasma derived fibrin sealant

Other:
• Sutures only
Standard of care

Locations

Country	Name	City	State
Belgium	Department of Neurosurgery, Ziekenhuis Oost Limburg	Genk
Belgium	Department of Neurosurgery, University Hospital of Liège	Liège
Finland	Department of Neurosciences and Rehabilitation, Tampere University Hospital	Tampere
France	Service de Neurochirurgie B, Hopital Neurologique de Lyon	Cedex
Germany	Klinik für Neurochirurgie, Universitätsklinikum Essen	Essen
Germany	Department of Neurosurgery, University Giessen-Marburg	Giessen
Germany	Department of Neurosurgery, Klinikum Ingolstadt GmbH	Ingolstadt
Germany	Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel	Kiel
Netherlands	VU Medical Centre	Amsterdam
United Kingdom	Department of Neurosurgery, Ninewells Hospital & Medical School	Dundee
United Kingdom	Edinburgh Centre for Neuro-Oncology, Western General Hospital	Edinburgh
United Kingdom	Department of Neurosurgery, John Radcliffe Hospital	Headington	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	OMRIX Biopharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of success	Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.	Day 1 (intraoperative)	Yes
Secondary	Incidence of CSF leakage		Day 5 post-op	Yes
Secondary	Incidence of CSF leakage		Day 30 post-op	Yes
Secondary	Incidence of adverse events		up to 30 days post-op	Yes
Secondary	Incidence of surgical site infections		Day 5 and 30 post-op	Yes