Effects of ethylene oxide resterilization and in-vitro degradation on mechanical properties of partially absorbable composite hernia meshes.

BACKGROUND AND AIM: Prosthetic mesh repair for abdominal wall hernias is widely used because of its technical simplicity and low hernia recurrence rates. The most commonly used material is pure polypropylene mesh, although newer composite materials are recommended by some centers due to their advantages.However, these meshes are more expensive than pure polypropylene meshes. Resterilization of a pure polypropylene mesh has been shown to be quite safe, and many centers prefer slicing a large mesh into smaller pieces, suitable for any hernia type or defect size. Nevertheless there is no data about the safety after resterilization of the composite meshes. The present study was carried out to investigate the effects of resterilization and in vitro degradation in phosphate buffered saline solution on the physical structure and the mechanical properties of partially absorbable lightweight meshes. METHODS: Two composite meshes were used in the study: One mesh consists of monofilament polypropylene and monofilament polyglecaprone -a copolymer of glycolide and epsilon(ε)- caprolactone - (Ultrapro®, 28 g m2, Ethicon, Hamburg,Germany), and the other one consisted of multifilament polypropylene and multifilament polyglactine (Vypro II®, 30g m2, Ethicon, Hamburg, Germany). Two large meshes were cut into rectangular specimens sized 50 x 20 mm for mechanical testing and 20 x 20 mm for in vitro degradation experiments.Meshes were divided into control group with no resterilization and gas resterilization. Ethylene oxide gas sterilization was performed at 55°C for 4.5 hours. In vitro degradation in 0.01M phosphate buffered saline (PBS, pH 7.4) solution at 37 ± 1°C for 8 weeks was applied to one subgroup in each mesh group. Tensiometric measurements and scanning electronmicroscopic evaluations were completed for control and resterilization specimens. RESULTS: Regardless of resterilization, when the meshes were exposed to in vitro degradation, all mechanical parameters decreased significantly. Highest reduction in mechanical properties was observed for Ultrapro due to the degradation of absorbable polyglecaprone and polyglactin parts of these meshes. It was observed that resterilization by ethylene oxide did not determine significant difference on the degradation characteristics and almost similar physical structures were observed for resterilized and non-resterilized meshes. For VyproII meshes, no significant mechanical difference was observed between resterilized and non-resterilized meshes after degradation while resterilized Ultrapro meshes exhibited stronger characteristics than non-resterilized counterparts, after degradation. CONCLUSION: Resterilization with ethylene oxide did not affect the mechanical properties of partially absorbable compositemeshes. No important surface changes were observed inscanning electron microscopy after resterilization.

EFFECTS OF ETHYLENE OXIDE RESTERILISATION AND IN-VITRO DEGRADATION ON MECHANICAL PROPERTIES OF PARTIALLY ABSORBABLE COMPOSITE HERNIA MESHES.

BACKGROUND: Prosthetic mesh repair for abdominal wall hernias is widely used because of its technical simplicity and low hernia recurrence rates. The most commonly used material is pure polypropylene mesh, however newer composite materials are recommended by some centers because of their advantages. However, these meshes are more expensive than pure polypropylene meshes. Resterilisation of a pure polypropylene mesh has been shown to be quite safe, and many centers prefer slicing a large mesh into smaller pieces that suitable for hernia type or defect size. Nevertheless there is no data about the safety after resterilisation of the composite meshes. OBJECTIVE: To search the effects of resterilisation and In vitro degradation in phosphate buffered saline solution on the physical structure and the mechanical properties of partially absorbable lightweigth meshes. DESIGN: Laboratory-based research. SUBJECTS: Two composite meshes were used in the study: One mesh is consisted of monofilament polypropylene and monofilament polyglecaprone--a copolymer of glycolide and epsilon (ε)-caprolactone--(Ultrapro®, 28 g/m2, Ethicon, Hamburg, Germany),andthe otherone consisted of multifilamentpolypropyleneandmultifilament polyglactine (Vypro II®, 30 g/m2,Ethicon, Hamburg, Germany). Two large meshes were cut into rectangular specimens sized 50x20 mm for mechanical testing and 20x20 mm for In vitro degradation experiments. Meshes were divided into control group with no resterilisation and gas resterilisation. Ethylene oxide gas sterilisation was performed at 55°C for 4.5 hours. In vitro degradation in 0.01 M phosphate buffered saline (PBS, pH 7.4) solution at 37 ± 1°C for 8 weeks was applied to one subgroup in each mesh group. Tensiometric measurements and scanning electron microscopyic evaluations were completed for control and resterilisation specimens. RESULTS: Regardless of resterilisation, when meshes were exposed to In vitro degradation, all mechanical parameters decreased significantly. Highest reduction in mechanical properties was observed for Ultrapro due to the degradation of absorbable polyglecaprone and polyglactin parts of these meshes. It was observed that resterilisation by ethylene oxide did not have significant difference on the degradation characteristics and almost similar physical structures were observed for resterilised and non-resterilised meshes. For Vypro II meshes, no significant mechanical difference was observedbetweenresterilised andnon-resterilised meshes after degradationwhile resterilised Ultrapro meshes exhibited stronger characteristics than non-resterilised counterparts, after degradation. CONCLUSION: Resterilisation with ethylene oxide did not affect the mechanical properties of partially absorbable composite meshes. No important surface changeswere observed in scanning electron microscopy after resterilisation.

Microfabrication of PDLLA scaffolds.

This study aimed to comprehend the potentialities of the microfabrication to produce tissue-engineering scaffolds. Structures presenting homogeneously distributed pores of size 100 and 200 µm were fabricated through layer-by-layer deposition of filaments of poly(D,L-lactic acid) (PDLLA) prepared from dichloromethane/dimethylformamide solutions. Rheological tests on the solution and molecular weight distributions of PDLLA, solvent cast films and microfabricated scaffolds were performed to determine which material conditions are optimal for the microfabricated system and to identify any possible material modification induced by the process. In vitro qualitative preliminary cell culture studies were conducted using MG63 osteoblast cell lines after assuring the non-cytotoxicity of the scaffold material by the lactate dehydrogenase in vitro toxicology assay; biological evaluations were initially performed using scaffolds with the smaller (100 µm) pore size. Scanning electron microscopy imaging was used to determine cell morphology distribution. A second cell culture test was performed, using the scaffold with the higher (200 µm) porosity. Confocal laser microscopy (CLM) was utilized to examine cell morphology and growth behaviour. Cellular metabolic activity and viability were also examined using Alamar Blue assay and further verifications were performed using CLM. Cell culture studies indicated homogeneous distribution, high viability and metabolic activity. Pore dimension affects cell distribution: pores < 100 µm acted as barrier structures for the MG63 osteoblast cell line; penetration inside the matrix was hindered and cells grew on the outer part. Increasing pore size resulted in a more homogeneous cell distribution and penetration of cells inside the structure was achieved.