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.

Study Overview

• Status: Completed
• Conditions: Subjects Scheduled for Supra-/Infratentorial Craniotomy
• Intervention / Treatment: Procedure: Craniotomy supra- or infratentorial, dural closure

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurence of CSF pad or leakage needing any kind of intervention.	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Nycomed
• Investigators: Principal Investigator: Mariani Luigi, Prof., University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: October 21, 2009
• First Posted (ESTIMATE): October 22, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2015
• Last Update Submitted That Met QC Criteria: September 14, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: CSF leakage; Craniotomy outcome; Dural sealant
• Other Study ID Numbers: Tachousb-1; EKBB 182/09 (OTHER: EKBB); Swissmedic 2009DR4198 (OTHER: Swissmedic)