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关于使用新型镀银钛合金器械预防脊柱手术部位感染的首个临床证据。

First Clinical Evidence About the Use of a New Silver-Coated Titanium Alloy Instrumentation to Counteract Surgical Site Infection at the Spine Level.

作者信息

Leggi Lucrezia, Terzi Silvia, Sartori Maria, Salamanna Francesca, Boriani Luca, Asunis Emanuela, Griffoni Cristiana, Giavaresi Gianluca, Gasbarrini Alessandro

机构信息

Spine Surgery, IRCCS-Istituto Ortopedico Rizzoli, Via G.C. Pupilli 1, 40136 Bologna, Italy.

Surgical Sciences and Technologies, IRCCS-Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.

出版信息

J Funct Biomater. 2025 Jan 16;16(1):30. doi: 10.3390/jfb16010030.

Abstract

Surgical site infections (SSIs) following spinal instrumentation surgery are among the most concerning complications. This study is aimed at assessing the effectiveness of a new treatment approach for SSIs that includes a single-stage approach with the removal of the previous hardware, accurate debridement, and single-stage instrumentation using a silver fixation system (SFS) made of titanium alloy coated with silver (Norm Medical, Ankara, Turkey) by means of a retrospective observational study. The demographic data, type of surgery, comorbidities, pathogens, and treatment details of consecutive patients with an SSI who received the SFS between 2018 and 2021 were extracted from their medical records and analyzed. The patients treated with the SFS for primary pyogenic infections were excluded. The patients were re-evaluated at multiple endpoints in order to assess the rate of reinfection and the local and general complications. Fifty-six patients were treated with the SFS and thirty-four patients met the inclusion criteria. Out of those 34 patients, the rate of infection recurrence or insurgence after the implantation of the SFS was 11.8%, with infection detected in 4 out of 34 cases and mechanical problems detected in 2 of the 34 cases (5.9%). The overall success rate in controlling infection recurrence or emergence was 88.2% (30 out of 34 cases). The overall survival rate of the SFS was 87%, 78%, and 71% at one, two, and three years, respectively. The surgical strategy with the SFS demonstrated promising outcomes in preventing infection recurrence or insurgence, with a low incidence of mechanical complications. However, further structured and comprehensive studies are essential for validating these initial findings.

摘要

脊柱内固定手术后的手术部位感染(SSIs)是最令人担忧的并发症之一。本研究旨在通过一项回顾性观察研究,评估一种针对SSIs的新治疗方法的有效性,该方法包括采用单阶段方法移除先前的内固定装置、精确清创以及使用由涂银钛合金制成的银固定系统(SFS,Norm Medical,土耳其安卡拉)进行单阶段内固定。从2018年至2021年间接受SFS治疗的连续SSIs患者的病历中提取人口统计学数据、手术类型、合并症、病原体及治疗细节并进行分析。排除接受SFS治疗原发性化脓性感染的患者。为评估再感染率以及局部和全身并发症情况,在多个时间点对患者进行重新评估。56例患者接受了SFS治疗,34例患者符合纳入标准。在这34例患者中,SFS植入后感染复发或新发率为11.8%,34例中有4例检测到感染,34例中有2例检测到机械问题(5.9%)。控制感染复发或新发的总体成功率为88.2%(34例中有30例)。SFS在1年、2年和3年时的总体生存率分别为87%、78%和71%。SFS手术策略在预防感染复发或新发方面显示出良好效果,机械并发症发生率较低。然而,需要进一步开展结构化和全面的研究来验证这些初步发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c81/11766446/7510e0e72326/jfb-16-00030-g0A1.jpg

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