Status:
NOT_YET_RECRUITING
Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery
Lead Sponsor:
The Affiliated Hospital Of Guizhou Medical University
Conditions:
Cranial Defect
Eligibility:
All Genders
18-80 years
Phase:
NA
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 af...
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\...
Eligibility Criteria
Inclusion
- Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage.
- Age 18 - 80 years.
- The first time for cranial repair.
- unilateral skull defect.
- Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection
- signed the informed consent.
Exclusion
- Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.).
- Fracture of bone flap ≥2 pieces, partial open fracture
- Intracranial infection before operation.
- Severe bone metabolic diseases.
- Long-term use of immunosuppressants.
- Pregnant or lactating women.
- Coagulation disorders.
- Severe cardiopulmonary insufficiency.
- It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery.
- Skull defect size less than 25cm².
- Life expectancy less than 1 year.
- mRS greater than 1 before primary disease.
- Diabetic patients.
- Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT07183540
Start Date
October 1 2025
End Date
September 1 2027
Last Update
September 19 2025
Active Locations (7)
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1
Anshun People's Hospital (Ward One)
Anshun, Guizhou, China, 561000
2
Anshun People's Hospital (Ward Two)
Anshun, Guizhou, China, 561000
3
The First People's Hospital of Bijie City
Bijie, Guizhou, China
4
Guizhou Provincial Workers' Hospital
Guiyang, Guizhou, China