Not Yet RecruitingNot Applicable

Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery

China582 participantsStarted 2025-10-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

modified Rankin Scale (mRS) 0-2

Timeframe: at 180 (± 7) days

Trial details

NCT IDNCT07183540

SponsorThe Affiliated Hospital Of Guizhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

Kaya Xu

13984843194 xkaya@sina.com

View on ClinicalTrials.gov More Cranial Defect trials