In-Vitro and Clinical Study on a Novel Synthetic Absorbable Dural Substitute

Objective: Dural substitutes play important role in trauma and skull base reconstruction surgeries. A new absorbable dural substitute (ReDura, Medprin Biotech, Frankfurt, Germany) in this study was developed and characterized with mechanical properties and biocompatibility. The safety and efficacy were evaluated in animal and clinical research. Study Design: The microstructure, mechanical properties, and cytotoxicity were evaluated. Canine model was used for dural defect repair experiment. A multicenter, randomized, single-blind, clinical trial was performed in four hospitals with 6 months follow-up. Patients: Finally 132 patients were enrolled commercially available Ethisorb (Johnson & Johnson, New Brunswick, New Jersey, United States) as control. Results: It exhibited unique 3D nonwoven microfibers structure with high mechanical strength and flexibility, and good biocompatibility in vitro. In animal study, complete defect closures and no CSF leakage were found. In clinical research, the postoperative CSF nonleakage rate of ReDura was 100% (control: 98.5%), subcutaneous nonexudate rate 93.9% (control: 92.3%), both with no significant difference. The same statistical results were presented on the patient body temperature from 1st to 10th day (p = 0.320-0.975) and the scalp wound healing on 10th day (p = 0.311), and safety indicators such as incidence of nausea, vomiting, meningeal irritation sign, and seizure at each time point (p = 0.205-0.971). Conclusions: The new biomimetic absorbable dural patch was proved to be the potentially ideal dural substitute.