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ClinicalTrials.gov ID

NCT07183540

Lead Sponsor

The Affiliated Hospital Of Guizhou Medical UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

582Estimated

Last Update Posted

Sep 19, 2025Actual

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Sep 1, 2027Estimated

Completion Date

Sep 1, 2027Estimated

Official Title

Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery: a Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study

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.

• Cranial Defect

• operation opportunity-within 6 weeks after the DC operation.
• operation opportunity-within 90 to 180 days after the DC operation.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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).

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

The Affiliated Hospital Of Guizhou Medical UniversityOTHER

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