再次灭菌对聚丙烯网片力学性能的影响。

Effects of resterilization on mechanical properties of polypropylene meshes.

作者信息

Serbetci Kemal, Kulacoglu Hakan, Devay Ali Onder, Hasirci Nesrin

机构信息

Department of Biomedical Engineering, Baskent University, Baglica Kampusu, Eskisehir Yolu 20. km, 06530, Ankara, Turkey.

出版信息

Am J Surg. 2007 Sep;194(3):375-9. doi: 10.1016/j.amjsurg.2005.11.018.

DOI:10.1016/j.amjsurg.2005.11.018

PMID:17693285

Abstract

BACKGROUND

The re-use of sterile packaged polypropylene meshes in hernia surgery is not recommended by the manufacturers. However, especially in developing and underdeveloped countries, many surgeons are obliged to re-use the mesh pieces after resterilization because of economic problems. The purpose of this study was to determine the effects of ethylene oxide and autoclave resterilization on the mechanical properties of polypropylene meshes.

METHODS

Repetitive ethylene oxide gas and autoclave sterilizations were applied to polypropylene meshes (Herniamesh S.r.l., San Mauro, Italy) up to 3 times and the effects on the mechanical properties were examined. Gas resterilizations were applied for 4.5 hours at 55 degrees C, whereas for autoclave resterilizations the specimens were kept at 134 degrees C and 3 atm pressure for 64 minutes. Ethylene oxide gas-sterilized samples were labeled as G(n) and autoclave-sterilized samples were labeled as A(n). Effects of the resterilizations on maximum load (Fmax), elongation at maximum load (deltaL), and energy required for complete failure of the specimen (E) were measured.

RESULTS

Fmax in the groups showed no significant differences. DeltaL values of groups A2, A3, and G3 were found to be significantly lower in comparison with the control group, whereas differences between the control group and other groups were not statistically significant. E values of A2 and A3 groups were significantly lower than that in the control group (P < .05), whereas the differences between the control group and other groups were not found to be statistically significant. No significant variations were determined between samples sterilized 1, 2, or 3 times in scanning electron microscopy micrographs, however, small irregularities were observed on autoclaved samples.

CONCLUSIONS

Single use of polypropylene meshes is always recommended because of biocompatibility and infection risks. However, if re-use of the open packages is needed, ethylene oxide sterilization is preferred over autoclave sterilization. If ethylene oxide sterilization is not available then 1 cycle of resterilization with an autoclave can be used.

摘要

背景

疝修补手术中重复使用无菌包装的聚丙烯补片未得到制造商的推荐。然而，尤其是在发展中国家和不发达国家，由于经济问题，许多外科医生不得不对补片进行再次灭菌后重复使用。本研究的目的是确定环氧乙烷和高压蒸汽再次灭菌对聚丙烯补片力学性能的影响。

方法

对聚丙烯补片（意大利圣毛罗的Herniamesh S.r.l.公司生产）进行高达3次的重复环氧乙烷气体和高压蒸汽灭菌，并检测其对力学性能的影响。气体再次灭菌在55℃下进行4.5小时，而高压蒸汽再次灭菌时，样本在134℃和3个大气压下保持64分钟。环氧乙烷气体灭菌的样本标记为G(n)，高压蒸汽灭菌的样本标记为A(n)。测量再次灭菌对最大负荷（Fmax）、最大负荷伸长率（δL）和样本完全破坏所需能量（E）的影响。

结果

各实验组的Fmax无显著差异。与对照组相比，A2、A3和G3组的δL值显著降低，而对照组与其他组之间的差异无统计学意义。A2和A3组的E值显著低于对照组（P < 0.05），而对照组与其他组之间的差异无统计学意义。扫描电子显微镜图像显示，灭菌1次、2次或3次的样本之间未发现显著差异，但在高压蒸汽灭菌的样本上观察到小的不规则现象。