Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

NCT00999999 | Completed Phase 4 DMC

• 3 other identifiers: Tachousb-1EKBB 182/09Swissmedic 2009DR4198
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjects Scheduled for Supra-/Infratentorial Craniotomy

Keywords

Craniotomy outcome; CSF leakage; Dural sealant

Outcome Measures

Primary Outcomes (1)

• Occurence of CSF pad or leakage needing any kind of intervention.

  30 days

Study Arms (2)

Standard

ACTIVE COMPARATOR

Standard dural closure

Procedure: Craniotomy supra- or infratentorial, dural closure

Experimental

EXPERIMENTAL

Experimental dural closure, adding of Investigational Medicinal Product (IMP)

Procedure: Craniotomy supra- or infratentorial, dural closure

Interventions

Craniotomy supra- or infratentorial, dural closure PROCEDURE

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; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of subdural empyema/abscess or any kind of infection affecting/infiltrating the dura mater
• Emergency for trauma
• Previous surgery on the same site
• Known hypersensitivity to TachoSil®
• Participation in another study
• Pregnancy
• Inability to read and understand the participant's information

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Nycomed: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25036199 DERIVED

MeSH Terms

Conditions

Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid Leak; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rhinorrhea; Signs and Symptoms, Respiratory; Wounds and Injuries

Study Officials

• Mariani Luigi, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

CH (1)