Used for repairing the defect of hard brain (spinal) membrane
Conditions
Interventions
Group1:Hard brain (spinal) membrane patch manufactured by zhuo ruan medical technology (suzhou) co., LTD
Group2:The biofilm patch was manufactured by Cook Biotech Incorporated
Sponsors
Shanghai tongji hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) aged 18-70 years old male and female; (2) patients with dural defect caused by various reasons (craniocerebral injury, brain tumor, cerebrovascular disease, congenital nervous system disease, spinal disease, etc.) and requiring surgical repair; (3) patients undergoing elective surgery; (4) can understand and cooperate with the clinical research process, and can comply with the requirements of the research program until the completion of the study; (5) patients who agree to enter the clinical study and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: (1) patients with severe craniocerebral injury causing bilateral pupil dilation and unstable vital signs; (2) patients with preoperative cardiac arrest caused by craniocerebral trauma combined with severe limb fractures or thoracic and abdominal injuries; (3) infection or inflammation in the surgical area; (4) patients with serious complications (such as blood system, respiratory system, digestive system, etc.); (5) patients with severe liver and kidney dysfunction; (6) mentally ill or severely mentally ill; (7) life expectancy less than 6 months; (8) people with allergy history to pig-derived products; (9) those who cannot accept pig-derived materials due to religious belief, ethnicity or other issues; (10) women with family planning within 12 months, pregnant or lactating patients; (11) the researchers considered that other patients were not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of dural repair; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effective rate of immediate control of cerebrospinal fluid leakage during operation;Incidence of cerebrospinal fluid leakage in postoperative MRI baseline setting;Instrument usability satisfaction; | — |
Countries
China
Contacts
Public ContactYanyan Wang
Zhuo Ruan Medical Technology (Suzhou) Co., Ltd.
Outcome results
None listed