Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

NCT ID: NCT00999999

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard

Standard dural closure

Group Type: ACTIVE_COMPARATOR

Craniotomy supra- or infratentorial, dural closure

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Craniotomy supra- or infratentorial, dural closure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nycomed

INDUSTRY

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariani Luigi, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 25036199 (View on PubMed)

Other Identifiers

EKBB 182/09

Identifier Type: OTHER

Identifier Source: secondary_id

Swissmedic 2009DR4198

Identifier Type: OTHER

Identifier Source: secondary_id

Tachousb-1

Identifier Type: -

Identifier Source: org_study_id