A Phase 4 interventional study of Craniotomy supra- or infratentorial, dural closure in Subjects Scheduled for Supra-/Infratentorial Craniotomy, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-15.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and 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.
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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The list of pathologies includes:
Exclusion Criteria:
Standard dural closure
Procedure: Craniotomy supra- or infratentorial, dural closure
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.
Occurence of CSF pad or leakage needing any kind of intervention.
Time frame: 30 days
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland