RESUMEN
BACKGROUND/AIM: Dural reconstruction is a critical process after neurosurgical procedures. Improper dural repair leads to serious side-effects, such as cerebrospinal fluid leakage or infection. This is why it is important to properly repair the dura using a dural substitute, and research into dural substitutes is ongoing. The ideal dural substitute should be non-toxic, biocompatible, and capable of maintaining adequate tension and preventing cerebrospinal fluid leakage for extended periods in vivo. This study evaluated the biocompatibility and healing properties of Safe-Seal, poly-L-lactic acid synthetic bioabsorbable dural substitute produced by electrospinning technology. MATERIALS AND METHODS: Safe-Seal, was created by electrospinning, which is a technique for nanofiberizing polymers into three-dimensional structures, and its cytotoxicity was evaluated. The animal study used 30 rats, divided into three groups assessed at two time points (4 and 12 weeks). The study groups were a negative control group with no treatment, an experimental group with Safe-Seal (TDM Co. Ltd., Gwangju, Republic of Korea) implantation, and a positive control group with a commercial product, Redura® (Medprin Biotech, Frankfurt, Germany) implantation. RESULTS: Safe-Seal exhibited no cytotoxic or adverse effects in the in vivo animal study. Histologically, Safe-Seal displayed less inflammatory cell infiltration, less adhesion to brain tissue, and connectivity with the surrounding dura mater as compared to the negative control group and without any significant differences from Redura® in all evaluation criteria. CONCLUSION: Safe-Seal presented adequate biocompatibility in vivo and contributed to the healing of the dura mater at a similar level to that of Redura® when applied to dural defects.