Membranous defect of the dura mater
Conditions
Interventions
Group 1:Bio-hard brain (spinal) membrane
Group 2:Bio-membrane(Heal-All)
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. A variety of causes caused by a defect in the hard brain (spinal) membrane, while patients who need a hard brain (spinal) membrane repair; 3. Elective surgery patients, expected surgical incision for Class I incision (clean incision) 4. Patients who are able to communicate well with researchers; 5. The patient agreed to conduct the study and voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. A person with severe damage to brain tissue and a critical condition; 2. Expected survival time of 6 months; 3. Poor control of diabetes, sepsis, systemic connective tissue disease, systemic infection, hydrocephalus, epilepsy patients; 4. Local infection at the proposed surgical site; 5. There are serious heart disease, unstable angina attacks, heart insufficiency, the researchers judged that it is not suitable for surgery; 6. Severe renal insufficiency, disease of hepatic insufficiency (liver failure, cirrhosis, venous hypertension and active hepatitis) and severe blood system history (e.g. clotting dysfunction, granulocyte reduction, osteocyte reduction, etc.), immunodeficiency or autoimmune diseases, the researchers judged that it is not suitable for surgery; 7. Cannot do magnetic resonance imaging examination, affect the outcome assessment judge; 8. Special allergy physique, especially known to be sensitive to collagen; 9. Participation in other interventional clinical trials; 10. Pregnant or lactating woman, or a pregnant patient during a planned study; 11. Have mental disorders or cognitive disorders; 12. There are any other factors that the researchers consider unsuitable for inclusion in this study or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of dural repair 12 weeks after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative repair success rate;Product ease of operation;The proportion of cerebrospinal fluid leakage was observed one week and 24 weeks after the operation;wound cicatrisation; | — |
Countries
China
Contacts
Public ContactShuo Wang
Outcome results
None listed