Subjects Scheduled for Supra-/Infratentorial Craniotomy Clinical Trial
Official 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.
| Verified date | September 2015 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 241 |
| Est. completion date | August 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Basel | Basel | Basel-Stadt |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | Nycomed |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurence of CSF pad or leakage needing any kind of intervention. | 30 days | No |