Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

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.

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Key information

Conditions

Subjects Scheduled for Supra-/Infratentorial Craniotomy Cerebrospinal Fluid Leak Cerebrospinal Fluid Rhinorrhea Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rhinorrhea Signs and Symptoms Signs and Symptoms, Respiratory Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

Nycomed

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Oct 22, 2009
Registry last updated: Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed