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一项多中心试验,分别在脊柱融合过程中观察有无椎弓根螺钉保护套时螺钉骨界面的细菌污染情况。

A Multicenter Trial Demonstrating Presence or Absence of Bacterial Contamination at the Screw-Bone Interface Owing to Absence or Presence of Pedicle Screw Guard, Respectively, During Spinal Fusion.

机构信息

University of Toledo, Toledo, OH.

Primus Super Speciality Hospital, New Delhi, Delhi, India.

出版信息

Clin Spine Surg. 2020 Oct;33(8):E364-E368. doi: 10.1097/BSD.0000000000000976.

DOI:10.1097/BSD.0000000000000976
PMID:32168115
Abstract

STUDY DESIGN

A prospective multicenter study.

OBJECTIVE

The objective of this study was to assess bacterial contamination in current practices of pedicle screw handling and comparing it to a novel method of using an intraoperative, sterile implant guard for screws.

SUMMARY OF BACKGROUND DATA

Postoperative infections occur at the higher end of 2%-13%, as cited in the literature, and are underestimated due to various reasons in such publications. Despite concerns associated with vancomycin application immediately before closure, it is theoretically impossible to irrigate the screw-bone interface postimplantation. Consequently, any contamination of pedicle screw before implantation is permanent, and has the potential to cause deep-bone infection, or hardware loosening due to encapsulation of biofilm between the bone and the screw. Therefore, continued vigilance and effective preventive measures should be undertaken if available.

MATERIALS AND METHODS

Two groups of presterile individually-packaged pedicle screws, one incased in a sterile, protective guard (group 1: G) and the other without such a guard (group 2: NG), 31 samples in each group were distributed over 28 spinal fusion surgeries at 5 independent hospitals groups. Each were loaded onto the insertion device by the scrub tech and left on the sterile table. Twenty minutes later, the lead surgeon who had just finished preparing the surgical site, handles the pedicle screw, to check the fit with the insertion device. Then, instead of implantation, it was transferred to a sterile container using fresh sterile gloves for bacterial analysis.

RESULTS

The standard unguarded pedicle screws presented bioburden in the range of 10 to 10 colonies forming units per screw, whereas the guarded pedicle screws showed no bioburden.

CONCLUSION

Standard, current, handling of pedicle screws leads to bacterial contamination, which can be avoided if the screws are sterilely prepackaged with an intraoperative guard (preinstalled).

摘要

研究设计

一项前瞻性多中心研究。

目的

本研究旨在评估目前椎弓根螺钉处理过程中的细菌污染情况,并将其与使用术中无菌植入物保护套的新型方法进行比较。

背景资料概要

文献中报道,术后感染发生率为 2%-13%,但由于各种原因,这些出版物中报道的感染率被低估。尽管在关胸前使用万古霉素存在相关问题,但在植入后理论上不可能对螺钉-骨界面进行冲洗。因此,任何在植入前对椎弓根螺钉的污染都是永久性的,有可能导致深部骨感染或因生物膜在骨与螺钉之间的包裹而导致硬件松动。因此,如果有条件,应继续保持警惕并采取有效的预防措施。

材料和方法

将两组未经消毒的单独包装的椎弓根螺钉,一组用无菌保护套包装(组 1:G),另一组无保护套(组 2:NG),每组 31 个样本,分布在 5 家独立医院的 28 例脊柱融合手术中。每个螺钉都由刷手护士装上插入装置,并放在无菌台上。20 分钟后,刚刚准备好手术部位的主刀医生会处理椎弓根螺钉,检查其与插入装置的适配性。然后,螺钉不是植入,而是用新的无菌手套转移到无菌容器中进行细菌分析。

结果

标准无保护的椎弓根螺钉的生物负荷范围为每颗螺钉 10 到 10 个菌落形成单位,而有保护的椎弓根螺钉则没有生物负荷。

结论

标准的当前椎弓根螺钉处理方法会导致细菌污染,如果螺钉在术中无菌包装时使用保护套(预安装),则可以避免这种污染。

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