Cranial Defect
Conditions
Interventions
Control group:After cold-chain transport to the bone tissue bank, the autologous skull will undergo standardized processing according to the group standard "T/CIRA 35—2022" for Autologous Skull Tissue
Trial Group:Following the same cold-chain transport and initial standardized processing as the control group (per "T/CIRA 35—2022"), the skull will undergo additional steps:
(1) Three-dimensional mode
Sponsors
Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Underwent decompressive craniectomy for trauma or cerebral hemorrhage; 2.Aged 18 to 65 years; 3.Undergoing first-time cranioplasty; 4.Presence of unilateral skull defect; 5.Provide written informed consent for the trial; 6.Provide written informed consent for autologous skull storage.
Exclusion criteria
Exclusion criteria: 1.Bone flap fragmented into two or more pieces; 2.History of multiple surgical repairs to the skull defect area; 3.History of brain tumor; 4.Presence of preoperative intracranial infection; 5.Severe bone metabolic disease; 6.Long-term use of glucocorticoids or immunosuppressants; 7.Significant size mismatch between the bone flap and the cranial window.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone resorption; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone resorption;Incidence rates of surgical site infection, exposure of skull bone, delayed wound healing, and subcutaneous fluid accumulation.;Incidence of intracranial hematoma;Incidence rate of hydrocephalus.;Epilepsy; | — |
Countries
China
Contacts
Public ContactLiu Jinfang/Bi Changlong
Xiangya Hospital of Central South University
Outcome results
None listed