Safety and validity of a new-type biological dura patch

doi:10.3969/j.issn.2095-4344.2014.25.003

Abstract

Abstract:

BACKGROUND: Dural repair materials in current application mainly include autologous tissue repair material, allograft material, heterogeneous biological material and synthetic material, most of which are imported products with expensive price.
OBJECTIVE: To evaluate safety and efficacy of a new biological type dura mater patch made in China based on animal experiments．
METHODS: Bilateral dura mater defect models were established in 24 healthy domestic dogs: on the left side of the implant model, a new type biological dura patch was transplanted as experimental group; on the right side, another brand artificial dura patch that was on sale was transplanted as control group. After 1, 3, 6 and 12 months of implantation, we compared degradation, angiogenesis, growth and surrounding tissue reaction of dural substitutes of the experimental group and control group by hematoxylin-eosin staining, detected residual dose of epoxy-cross-linked agent in dogs’ blood and cerebrospinal fluid by fluorescence spectrophotometry.
RESULTS AND CONCLUSION: During 1-12 months of implantation, all dogs grew well and no infection or motor disorder was observed. Pathological examination showed that dura substitutes of the experimental group and control group had good biocompatibility, no or slightly inflammatory response. After 6 months of implantation, the surface of the new biological dural substitute (experimental group) was degraded and became a transit-state biomaterial with surrounding tissue, but the control group materials showed no degradation. After 12 months of implantation, the dura patch in the experimental group degraded nearly 50%, which appeared with
neovascularization; while, the dura patch in the control group degraded 30%, and neovascularization was observed in only a small amount of samples. Epoxy compounds of cross-linked agent were not detected in dogs’ blood and cerebrospinal fluid after 1, 3, 7 and 14 postoperative days. These findings show that this new type of biological dural substitute is a safe and effective dural repair material.

Key words: meninges, biocompatible materials, reconstructive surgical procedures

CLC Number:

R318

Chang Hong-bo, Pan Teng-fei, Lu Wang-sheng, Wang Peng, Cui Kai, Zhang Jian-ning. Safety and validity of a new-type biological dura patch[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(25): 3947-3952.

Figures/Tables 1

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