Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

Phase 4

Completed

• Conditions: Subjects Scheduled for Supra-/Infratentorial Craniotomy
• Interventions: Procedure: Craniotomy supra- or infratentorial, dural closure

• Registration Number: NCT00999999
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Craniotomy supra- or infratentorial, dural closure	Standard dural closure
Experimental	Craniotomy supra- or infratentorial, dural closure	Experimental dural closure, adding of Investigational Medicinal Product (IMP)

Primary Outcome Measures

Name	Time	Method
Occurence of CSF pad or leakage needing any kind of intervention.	30 days

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland