Biocompatibility evaluation of dura mater substitutes in an animal model

Abstract

Dura-Guard Dural Repair Patch, PRECLUDE Dura Substitute, and Codman ETHISORB Dura Patch were evaluated in a six-month dural tissue reaction study in rabbits. Bilateral craniotomy was followed by subdural implantation for each dura mater substitute. The surgical procedure for the sham control group was the same except that no material was implanted. Implantation of all of these dura mater substitutes for 28, 91, or 182 days post-implantation did not result in any deaths or clinical neurobehavioral abnormalities, changes in cerebrospinal fluid, or significant macroscopic changes at necropsy. However, histomorphologic evaluation of the implantation sites revealed some differences in the tissue response to these materials. For Dura-Guard Dural Repair Patch, a nonabsorbable material derived from bovine pericardium, the implantation site was characterized by fibrosis of the overlying area with islands of osseous metaplasia and adhesions to the brain surface. Over time, infiltrative fibrosis of the implant resulted in separation of the collagenous layers of the implant and compression of the underlying brain. Fibrosis of the overlying area that incorporated this material formed a 'replacement' dura mater. Adhesions to the brain surface observed initially were still present at six months post-implantation. Implantation of PRECLUDE Dura Substitute, a nonabsorbable material comprised of expanded polytetrafluoroethylene, resulted in virtually no early reaction, and few adhesions to the brain surface at any time period. Although this material was eventually incorporated by fibrosis, islands of osseous metaplasia were also observed in this 'replacement' dura mater. The tissue reaction to Codman ETHISORB Dura Patch, an absorbable material comprised of polyglactin 910 and polydioxanone, was generally characterized by low-grade granulomatous inflammation and initial adhesions to the brain surface. The three-dimensional structure of this implant acted as a scaffold to guide the development and integration of a 'replacement' dura mater. The absorption of the material was associated with complete resolution of the inflammatory reaction, a lack of cerebral adhesions, and restoration of the normal architecture of this region. In conclusion, subdural implantation of Dura-Guard Dural Repair Patch, PRECLUDE Dura Substitute, or Codman ETHISORB Dura Patch in rabbits for up to six months resulted in the eventual restoration of the dura mater without significant adverse effects. However, osseous metaplasia associated with nonabsorbable Dura-Guard Dural Repair Patch and PRECLUDE Dura Substitute, and the infiltration of Dura-Guard Dural Repair Patch by fibrosis suggests that long-term follow-up may be needed after the use of these materials in patients. An advantage of Codman ETHISORB Dura Patch was that it was completely absorbed after guiding the restoration of the dura mater without any morphological sequelae.

Proliferation rate of human osteoblast-like cells on alloplastic biomaterials and their clinical application for the transnasal duraplasty procedure

“…The porous structure of the vicryl fleece permits an immigration of endogenous tissue, the undyed PDS-thread is intended to support fluid impermeability and minimize the formation of cortical adhesions. Futher studies [26,27] in animals and humans analysed the biocompatibility of vicryl fleece in six month follow up examinations and it was generally characterized by low-grade granulomatous inflammation and initial adhesions to the brain surface. The three-dimensional structure of this implant acted as a scaffold to guide the development and integration of a 'replacement' dura mater.…”

Proliferation and Osteogenic Differentiation of Mesenchymal Stem Cells Cultured onto Three Different Polymers In Vitro

“…Although histological analysis demonstrated slight advantages for cell-loaded PGPD in regard to local bone healing within the transplantation area, the roentgenograms showed that the presence of PGPD did not enhance the fusion rate compared to periosteal cells with fibrin and without PGPD. 51 In contrast to these findings, Barbolt et al 6 tested the in vivo biocompatibility of PGPD and reported a low-grade granulomatous inflammation within the first 6 months and a complete resolution of the inflammatory reaction after complete bioabsorption of PGPD. It is hypothesized that these findings may be based not only on a low initial biocompatibility of PGPD but also on in vivo degradation effects.…”

“…20,38,66 Diaphyseal canal restrictors containing polydioxanone are used in cemented femoral hip arthroplasty and polydioxanone fleeces are applied to reconstruct bony defects in maxillofacial and neurosurgeries. 6 Although all of these three biomaterials have already been applied in bone reconstructive surgery for many years, there is a lack of data with regard to the in vitro osteogenic potency and adherence potency for MSCs. Furthermore, it has been shown by several authors 35,36,52 that dexamethasone-, ascorbic acid-, and β-glycerolphosphate (DAG)-supplemented culture media promote osteoblastic differentiation of MSCs in vitro.…”

Long-term follow-up of blowout fractures of the orbital floor reconstructed with a polyglactin 910/PDS implant

“…It is reported to be completely resorbed after a period of three months. The material is replaced with fibrous collagenous tissue, and minimal inflammation is associated with this process [14,[19][20][21][22]. Subsequently, indications for its use were extended to the orbital floor [6,14].…”