Local Tolerance and Biodegradability of a Novel Artificial Dura Mater Graft Following Implantation Onto a Dural Defect in Rabbits

Abstract

Dura mater defects are a common problem following neurosurgery. Dural grafts are used to repair these defects; among them are biodegradable polymeric synthetic grafts. ArtiFascia is a novel synthetic and fibrous Dural graft, composed of poly(l-lactic-co-caprolactone acid) (PLCL) and poly(d-lactic-co-caprolactone acid). In this study, the biodegradability and local tolerance of ArtiFascia was evaluated in rabbits and compared with a bovine collagen matrix as a reference control. ArtiFascia implantation resulted in the formation of neo-dura at the site of implantation and recovery of the dural damage and the calvaria bone above. The implanted graft was completely absorbed after 12 months and the remaining macrophages were morphologically consistent with the anti-inflammatory M2-like phenotype, which contributes to tissue healing and are not pro-inflammatory. The site of the drilled skull bone had a continuous smooth surface, without exuberant tissue or inflammation and a newly formed trabecular bone formation indicated the healing process of the bone. These results support the local tolerability and biodegradability of ArtiFascia when used as a dural graft in rabbits. This study suggests that PLCL-based grafts including ArtiFascia are safe and effective to repair Rabbit Dura.

[Retracted] The Study of Expanded Polytetrafluoroethylene New Material in Dural Repair

“…According to reports, dural defects are not uncommon in neurosurgery, and they are an important factor in inducing cerebrospinal fluid leakage, intracranial infection, meningitis, encephalocele, and epilepsy. Therefore, a series of studies have been carried out for dural repair to reduce the risk of clinical treatment [4][5][6][7].…”

Preclinical In-Vivo Safety of a Novel Thyrotropin-Releasing Hormone-Loaded Biodegradable Nanoparticles After Intranasal Administration in Rats and Primates

“…Therefore, the development of a new delivery device should include well-designed, regulated in vivo safety and toxicity studies. [37][38][39][40][41][42][43][44][45] Therefore, we performed two animal safety studies, one in rats another in cynomolgus monkeys, which historically have been used in safety evaluation studies and are recommended by appropriate regulatory agencies. Furthermore, it was essential to test whether the use of TRH in an intranasal route of administration can lead to any adverse events, since there is very little information on the in vivo safety of TRH when given intranasally.…”

Beyond Tissue replacement: The Emerging role of smart implants in healthcare

“…Moreover, biodegradable implants are generally known for their low risk to cause inflammatory reactions, if there is no need to remove them [ 253 ]. Numerous studies have demonstrated the absence of inflammatory reactions in biodegradable implants [ 254 , 255 ]. However, if it is necessary to extract a biodegradable implant for one reason or another, the risk of inflammatory reactions increases [ 256 ], although in recent times the need for the extraction of biodegradable implants is becoming less frequent [ 257 , 258 ].…”