Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Takeda
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

October 21, 2009
June 12, 2012
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999999 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
226
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
Both
18 Years and older
No
Contact: Luigi Mariani, MD marianil@uhbs.ch
Contact: Hutter Gregor, MD PhD hutterg@uhbs.ch
Switzerland
 
NCT00999999
Tachousb-1, EKBB 182/09, Swissmedic 2009DR4198
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Takeda
Principal Investigator: Mariani Luigi, Prof. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
June 2012

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