Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

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. Identifier: NCT00999999
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : September 15, 2015
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

October 21, 2009
October 22, 2009
September 15, 2015
October 2009
July 2012   (Final data collection date for primary outcome measure)
Occurence of CSF pad or leakage needing any kind of intervention. [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00999999 on Archive Site
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Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment
Fleece Bound Tissue Sealing With TachoSil® to Assist in Closing of the Dura Mater After Elective Craniotomy to Reduce Postoperative Cerebrospinal Fluid (CSF) Leakage.

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.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Subjects Scheduled for Supra-/Infratentorial Craniotomy
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.
  • Active Comparator: Standard
    Standard dural closure
    Intervention: Procedure: Craniotomy supra- or infratentorial, dural closure
  • Experimental: Experimental
    Experimental dural closure, adding of Investigational Medicinal Product (IMP)
    Intervention: Procedure: Craniotomy supra- or infratentorial, dural closure
Hutter G, von Felten S, Sailer MH, Schulz M, Mariani L. Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial. J Neurosurg. 2014 Sep;121(3):735-44. doi: 10.3171/2014.6.JNS131917. Epub 2014 Jul 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
EKBB 182/09 ( Other Identifier: EKBB )
Swissmedic 2009DR4198 ( Other Identifier: Swissmedic )
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University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Principal Investigator: Mariani Luigi, Prof. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP