200
Participants
Start Date
September 14, 2017
Primary Completion Date
September 20, 2019
Study Completion Date
September 20, 2019
Bioseal
Upon completion of the sutured dural repair, the closure will be evaluated for intra-operative CSF leakage with a baseline Valsalva maneuver to 10-20 cm H2O for 5-10 seconds. Subjects who have a CSF leak will be enrolled into the study. If randomized to receive Bioseal, a thin layer will be applied to the entire length of the suture line and the adjacent area to approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used for each application. While Bioseal achieves complete coagulation, CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds.
Xuanwu Hospital Capital Medical University, Beijing
The First Hospital of Jilin University, Changchun
Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai
The First Affiliated Hospital of Soochow University, Suzhou
The Affiliated Hospital of Xuzhou Medical University, Xuzhou
The First Affiliated Hospital of Fujian Medical University, Fuzhou
TongJi Hospital, TongJi Medical College of HUST, Wuhan
ZhuJiang Hospital of Southern Medical University, Guangzhou
The Affiliated Hospital of Guizhou Medical University, Guiyang
The first Affiliated Hospital of Zhengzhou University, Zhengzhou
Guangzhou Bioseal Biotechnology Co., Ltd.
INDUSTRY