Cranial Defect
Conditions
Keywords
Decompressive craniectomy and Cranioplasty, operation opportunity, ultra-early, Autologous skull
Brief summary
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3\ 6 months after DC.
Detailed description
Objective: To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3\ 6 months after DC. Design: This study is a multi-center, prospective, randomized controlled, open-label trial. Interventions: Intervention measures were the time point of cranioplasty: within 6 weeks after decompressive craniectomy VS 3-6 months after decompressive craniectomy.
Interventions
PROCEDUREoperation opportunity-within 6 weeks after the DC operation.
The autologous skull repair surgery will be completed within 6 weeks after the DC operation.
PROCEDUREoperation opportunity-within 90 to 180 days after the DC operation.
The autologous skull repair surgery should be completed within 90 to 180 days after DC.
Sponsors
The Affiliated Hospital Of Guizhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study was open-label, endpoint-blinded, i.e. only the patients themselves and the treating physicians knew the randomization assignment results, baseline was evaluated by investigators who did not know the actual patient assignment, and primary endpoint visits were conducted by trained third parties who did not know what treatment the patients received.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage. 2. Age 18 - 80 years. 3. The first time for cranial repair. 4. unilateral skull defect. 5. Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection 6. signed the informed consent.
Exclusion criteria
1. Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.). 2. Fracture of bone flap ≥2 pieces, partial open fracture 3. Intracranial infection before operation. 4. Severe bone metabolic diseases. 5. Long-term use of immunosuppressants. 6. Pregnant or lactating women. 7. Coagulation disorders. 8. Severe cardiopulmonary insufficiency. 9. It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery. 10. Skull defect size less than 25cm². 11. Life expectancy less than 1 year. 12. mRS greater than 1 before primary disease. 13. Diabetic patients. 14. Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale (mRS) 0-2 | at 180 (± 7) days | The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of intracranial hemorrhage | 90 days (±7 days) and 180 days (±7 days) after CP surgery | — |
| incidence of epilepsy | 90 days (±7 days) and 180 days (±7 days) after CP surgery | — |
| incidence of reoperation | 90 days (±7 days) and 180 days (±7 days) after CP surgery | — |
| mRS≤2 and mRS ≤3 | 90 (±7) days after CP | Proportion of mRS≤2 and proportion of mRS ≤3 |
| mRS ≤3 | 180 (±7) days after CP | Proportion of mRS≤2 and proportion of mRS ≤3 |
| Glasgow Outcome Score (GOS) | 90 days (±7 days) and 180 days (±7 days) after CP surgery | Minimum score 1 and maximum score 8 with higher number being better outcome |
| hydrocephalus or Cerebrospinal fluid shunt surgery rate | 90 days (±7 days) and 180 days (±7 days) after CP surgery | The incidence of hydrocephalus or CSF shunt surgery |
| Total medical expenses (excluding materials) | At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge | — |
| Complications related medical expenses | At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge | — |
| Incidence of infection, poor healing, and subcutaneous effusion | 90 days (±7 days) and 180 days (±7 days) after CP surgery | — |
| Mini-Mental State Examination (MMSE) score | 90 days (±7 days) and 180 days (±7 days) after CP surgery | Minimum score 0 and maximum score 30 with higher score being better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality rate | 180 (±7) days after CP surgery | All etiology of mortality |
Countries
China
Contacts
Primary ContactKaya Xu
Outcome results
None listed