Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGSurgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days after the surgery (Confirmed by radiological image evaluation and physical examination on surgical site). Each patient firstly undergoes an initial CT and if necessary, MRI will be used to further examine the volume of CSF leakage.
Time frame: 90days
Sally Jin
CONTACT
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