ABSTRACT
Background: In neurosurgery, the integrity of the dura is very important for brain surgery subjects, and the meningeal repair material play an important role in the reconstruction of the dura integrity, protection of brain tissue, and the prevention of complications such as cerebrospinal fluid leakage, intracranial infection, encephalocele, epilepsy, etc. Brain trauma, brain tumors, cerebrovascular disease, increase of cranial content volume, some congenital diseases, surgical procedure itself and other factors may cause the dura defect, which needs to use other alternative materials to repair the defective dura in order to maintain the integrity of the anatomical structure.
Objective: In this research, the efficacy and safety performance of a new developed dural substitute ReDura would be validated through a multi-center, randomized, single-blind clinical trial.
Methods: In this clinical trial, 132 subjects (66 cases for ReDura and control group respectively) would be enrolled and 6 months were followed up. The efficacy evaluation would be performed by cerebrospinal fluid non-leakage rate, body temperature observation and scalp wound healing. The safty performancewould be evaluated by such indicators as cellular immunity and humoral immunity inspection, incidence of infection, incidence of seizure.
Results: The postoperative cerebrospinal fluid non-leakage and/or subcutaneous hydrops rate was 93.9% (62/66) for experiment group and 92.3% (60/65) for control group, with no significant difference between the two groups. No difference was observed in the body temperature before and after the surgery at each visit between the two groups, 10 days after the surgery no statistical difference in scalp wound healing between the two groups. It can be concluded that ReDura is effective in the repair surgery. No statistical difference was observed in the incidence of nausea, vomiting, meningeal irritation and the seizure at each time point after the surgery between the two groups. 10 days after the surgery, 13 patients in experiment group had 28 laboratory indicators changed from normal to abnormal with clinical significance, and 18 patients in control group had 39 laboratory indicators changed from normal to abnormal with clinical significance. No difference was observed between the two groups. Safety performance was also proved in clinical.
Conclusions: This multi-center, randomized, single-blind clinical trial proved that ReDura is not inferior in efficacy and with no significant statistical difference in safety from commercially available Ethisorb. This new regenerative dural patch is worth being recommended in dural defect surgery.
Key words: Dual substitute, Dura mater, ReDura, PLLA, CSF
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