Clinical trial NCT00999999: Efficacy of Tachosil as Dural Sealant Compared to Standard 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subjects Scheduled for Supra-/Infratentorial Craniotomy
Keywords: Craniotomy outcome
CSF leakage
Dural sealant
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Nycomed
First posted: 2009-10-22
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Occurence of CSF pad or leakage needing any kind of intervention.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mariani Luigi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.