The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Adjunctive bioresorbable patch
Elisabeth TweeSteden Ziekenhuis
Tilburg, Netherlands
UMCU
Utrecht, Netherlands
University Hospital Zurich
Zurich, Switzerland
Incidence of wound infection confirmed by increase of CRP and positive cultures
wound infection confirmed by increase of CRP and positive cultures
Time frame: up to 30 days after surgery
Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)
intra-operative CSF leakage
Time frame: intra-operative
Incidence of percutaneous CSF leak confirmed by β-2 transferrin test
Percutaneous CSF leak confirmed by β-2 transferrin test
Time frame: up to 30 days after surgery
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