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Dural patch for dural defect repair The safety and effectiveness of clinical trials

Dural patch for dural defect repair The safety and effectiveness of clinical trials

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046523
Enrollment
Unknown
Registered
2021-05-20
Start date
2016-08-01
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dura defect

Interventions

Experimental group vs control group:dural patch

Sponsors

General Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with dural defect caused by various reasons (such as brain injury, brain tumor, cerebrovascular disease, congenital nervous system disease, spine disease, etc.) and who need surgical repair; 3. The surgical incision grade is Grade I; 4. The estimated survival period is greater than 6 months; 5. The patient agrees to participate in the clinical trial, signs an informed consent form, and can complete the follow-up of the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial metal implants that will affect imaging evaluation; 2. The patient has serious organic diseases (heart, liver, kidney, circulatory system, etc.); 3. Patients with unstable vital signs; 4. Patients with coma and/or lethargy (Glass coma score <8); 5. Patients who are allergic to known substances or drugs during the test; 6. Patients with local craniocerebral infection and hydrocephalus; 7. Acute malignant encephalocele during the operation causes difficulty in closing the skull; 8. Patients who need radiotherapy and/or chemotherapy within 12 weeks before surgery and (or) 10 weeks after surgery; 9. Uncontrolled diabetes, sepsis, systemic connective tissue disease (rheumatism, systemic lupus erythematosus, etc.) or suffering from autoimmune diseases; 10. Patients who have participated in other clinical trials within 2 months; 11. Women during pregnancy or lactation; 12. Other researchers believe that it is not suitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Effectiveness of prevention of postoperative cerebrospinal fluid leakage;

Countries

China

Contacts

Public ContactYue Shuyuan

General Hospital of Tianjin Medical University

xinchentianjin@me.com+86 13820068878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026