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Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00999999
First received: October 21, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

Main objective of this trial is to assess the hypothesis whether the application of TachoSil® as a dural sealant improves the quality of craniotomy procedure and outcome in general compared with standard dural closure techniques in a controlled and randomized way. As a primary endpoint the investigators look at possible postoperative occurrence of CSF pads or leakages needing any kind of intervention until day 30 after the primary craniotomy. Furthermore, the investigators will look at other surgery-related complications and at pharmacoeconomic endpoints such as hospital stay or cost of the implant. Overall, the results of this study will provide important information on whether or not the adjunct of a relatively expensive implant on a routinely basis for the closure of elective craniotomies is safe and effective, or not.

To date, TachoSil® is often used in neurosurgery and other surgical disciplines in a non-standardized fashion also to prevent CSF leakage after dural closure. So far, adverse events directly related to the product have not been reported. Theoretically, any implant may be associated with a higher incidence of postoperative infections (e.g. epidural, subdural or subgaleal empyema). On the other hand, it is not known whether or not the application of TachoSil® on the dural suture may reduce CSF leakage.


Condition Intervention Phase
Subjects Scheduled for Supra-/Infratentorial Craniotomy
 Procedure: Craniotomy supra- or infratentorial, dural closure
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fleece Bound Tissue Sealing With TachoSil® to Assist in Closing of the Dura Mater After Elective Craniotomy to Reduce Postoperative CSF Leakage.

Resource links provided by NLM:

Drug Information available for: TachoSil
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Occurence of CSF pad or leakage needing any kind of intervention. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: October 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard
Standard dural closure
 Procedure: Craniotomy supra- or infratentorial, dural closure
After dural closure with a water-tight suture, randomization is performed. Depending on the randomization outcome, the study drug Tachosil is applied on the dural suture or omitted.
Experimental: Experimental
Experimental dural closure, adding of IMP
 Procedure: Craniotomy supra- or infratentorial, dural closure
After dural closure with a water-tight suture, randomization is performed. Depending on the randomization outcome, the study drug Tachosil is applied on the dural suture or omitted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neurosurgical indication for craniotomy and opening of dura to access cerebral structures/pathologies (discussed in the indication conference of board certified neurosurgeons at the University Hospital of Basel).

  • The list of pathologies includes:

    • primary or secondary benign/malignant brain tumors
    • aneurysms
    • arterious-venous malformations
    • cavernomas
    • pituitary adenomas
    • temporal lobectomy (epilepsy surgery)
    • longterm posttraumatic revisions.

Exclusion Criteria:

  • Presence of subdural empyema/abscess or any kind of infection affecting/infiltrating the dura mater
  • Emergency for trauma
  • Previous surgery on the same site
  • Cases, where water-tight dural suture is not possible (intraoperative exclusion decision)
  • Known hypersensitivity to TachoSil®
  • Participation in another study
  • Pregnancy
  • Inability to read and understand the participant's information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999999

Contacts
Contact: Luigi Mariani, MD marianil@uhbs.ch
Contact: Hutter Gregor, MD PhD hutterg@uhbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Luigi Mariani, MD         marianil@uhbs.ch    
Contact: Gregor Hutter, MD PhD         hutterg@uhbs.ch    
Principal Investigator: Luigi Mariani, MD, Prof.            
Sub-Investigator: Hutter Gregor, MD PhD            
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Mariani Luigi, Prof. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00999999     History of Changes
Other Study ID Numbers: Tachousb-1, EKBB 182/09, Swissmedic 2009DR4198
Study First Received: October 21, 2009
Last Updated: June 12, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Craniotomy outcome
CSF leakage
Dural sealant

ClinicalTrials.gov processed this record on May 22, 2013