Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Fleece Bound Tissue Sealing With TachoSil® to Assist in Closing of the Dura Mater After Elective Craniotomy to Reduce Postoperative Cerebrospinal Fluid (CSF) Leakage.

Conditions
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Subjects Scheduled for Supra-/Infratentorial Craniotomy

Intervention / Treatment
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* Procedure: Craniotomy supra- or infratentorial, dural closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Standard dural closure | Procedure: Craniotomy supra- or infratentorial, dural closure<br>* 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.<br>|
| Experimental: Experimental<br>Experimental dural closure, adding of Investigational Medicinal Product (IMP) | Procedure: Craniotomy supra- or infratentorial, dural closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniotomy outcome, CSF leakage, Dural sealant