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Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999999
First Posted: October 22, 2009
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nycomed
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Cerebrospinal Fluid (CSF) Leakage.

Resource links provided by NLM:


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 ]

Enrollment: 241
Study Start Date: October 2009
Study Completion Date: August 2012
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 Investigational Medicinal Product (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999999


Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Nycomed
Investigators
Principal Investigator: Mariani Luigi, Prof. University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00999999     History of Changes
Other Study ID Numbers: Tachousb-1
EKBB 182/09 ( Other Identifier: EKBB )
Swissmedic 2009DR4198 ( Other Identifier: Swissmedic )
First Submitted: October 21, 2009
First Posted: October 22, 2009
Last Update Posted: September 15, 2015
Last Verified: September 2015

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