Cranial Defect
Conditions
Interventions
Observation group:None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age > 18 years, able and willing to sign the informed consent form; 2.Having undergone decompressive craniectomy due to trauma or tumor surgery, with a post-operative cranial defect area between 25 cm^2 and 100 cm^2; 3.Time since decompressive craniectomy is 1-3 months, with well-healed scalp soft tissue, no active infection or chronic inflammation, and cranial repair surgery is feasible according to routine diagnosis and treatment; 4.Voluntary agreement to undergo cranioplasty using the novel cranial patch; 5.The patient has no history of any prior material implantation in the skull; 6.Stable intracranial condition, with no signs of midline shift, significant peritumoral edema, or rapidly progressing clinical symptoms.
Exclusion criteria
Exclusion criteria: 1.Patients at risk of surgical site infection (underwent 2 or more previous craniotomies, had neurosurgery within the past 3 months, poor skin condition, and/or infection in the previous surgical area); 2.Malignant brain tumor showing signs of recurrence; 3.Uncontrolled epilepsy; 4.Persistent manifestations of intracranial hypertension; 5.Known intracranial aneurysm or spontaneous intratumoral hemorrhage; 6.Patients with coils, clips, shunts, endovascular stents, and/or non-removable wafers, non-absorbable dural substitutes, or reservoirs; 7.Patients requiring ongoing antiplatelet therapy for medical reasons; 8.Known or suspected active or chronic infection; 9.Patients with concurrent infections requiring intravenous antibiotic therapy, or unexplained fever (body temperature >= 37.5°C); 10.Study participants with uncontrolled systemic diseases or relevant medical history, such as diabetes, current or history of organic cardiovascular or cerebrovascular diseases, cardiac dysfunction (Grade 2 or higher), hypertension (Grade 2 or higher), first-degree or higher atrioventricular block, previous history of myocardial infarction, previous history of myocarditis, pulmonary dysfunction, thyroid dysfunction, or cerebral infarction within the past six months; 11.Study participants with active autoimmune diseases or relevant medical history, such as ulcerative colitis, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or granulomatosis with polyangiitis (Wegener’s granulomatosis); 12.Study participants planning or requiring administration of any live vaccine during the screening or treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ultrasound imaging data(including grayscale images, Doppler images, and RF signals); | — |
Countries
China
Contacts
Public ContactDing Hong
Huashan Hospital, Fudan University
Outcome results
None listed