Guarch-Pérez Clara, Shaqour Bahaa, Riool Martijn, Verleije Bart, Beyers Koen, Vervaet Chris, Cos Paul, Zaat Sebastian A J
Department of Medical Microbiology and Infection Prevention, Amsterdam Institute for Infection and Immunity, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
Mechanical and Mechatronics Engineering Department, Faculty of Engineering & Information Technology, An-Najah National University, Nablus P.O. Box 7, Palestine.
Pharmaceutics. 2022 Jun 28;14(7):1363. doi: 10.3390/pharmaceutics14071363.
Bacterial infections are a serious healthcare complication in orthopedic and trauma surgery worldwide. Compared to systemic, local antibiotic prophylaxis has been shown to provide a higher antibiotic dose and bioavailability at the bone site with minimum toxic effects. However, there are still not enough biomaterial and antibiotic combinations available for personalized implant sizes for patients. The aim of this study was to develop a bone fixation plate coating made of a composite of poly-ε-caprolactone, hydroxyapatite and halloysite nanotubes loaded with gentamicin sulphate and fabricated via fused filament fabrication 3D printing technology. The mechanical and thermal properties of the biomaterial were analyzed. The in vitro release kinetics of gentamicin sulphate were evaluated for 14 days showing a burst release during the first two days that was followed by a sustained release of bactericidal concentrations. The composite loaded with 2 and 5% gentamicin sulphate exhibited complete antimicrobial killing of in an ex vivo mouse femur fixation plate infection model. Moreover, a fixation plate of the composite loaded with 5% of gentamicin sulphate was able to prevent infection in the bone and surrounding tissue in an in vivo mouse bone fixation plate infection model 3 days post-surgery. In conclusion, the newly developed composite material successfully prevented infection in vivo. Additionally, the ability to use fused filament fabrication 3D printing to produce patient-specific implants may provide a wider range of personalized solutions for patients.
在全球范围内，细菌感染是骨科和创伤外科手术中一种严重的医疗并发症。与全身使用抗生素相比，局部抗生素预防已被证明能在骨部位提供更高的抗生素剂量和生物利用度，且毒性最小。然而，对于患者个性化植入物尺寸而言，可用的生物材料和抗生素组合仍然不足。本研究的目的是开发一种骨固定板涂层，该涂层由聚ε-己内酯、羟基磷灰石和负载硫酸庆大霉素的埃洛石纳米管的复合材料制成，并通过熔融沉积成型3D打印技术制造。分析了该生物材料的力学和热性能。对硫酸庆大霉素的体外释放动力学进行了14天的评估，结果显示在前两天有一个突释过程，随后是杀菌浓度的持续释放。在体外小鼠股骨固定板感染模型中，负载2%和5%硫酸庆大霉素的复合材料表现出对[此处原文缺失相关细菌名称]的完全抗菌杀灭作用。此外，在体内小鼠骨固定板感染模型中，负载5%硫酸庆大霉素的复合材料制成的固定板在术后3天能够预防骨和周围组织的[此处原文缺失相关细菌名称]感染。总之，新开发的复合材料在体内成功预防了感染。此外，利用熔融沉积成型3D打印生产患者特异性植入物的能力可能为患者提供更广泛的个性化解决方案。
