Schmidmaier G, Kerstan M, Schwabe P, Südkamp N, Raschke M
Trauma and Reconstructive Surgery HTRG, Center of Orthopaedics, Traumatology and Spinal Cord Injury - University Clinic of Heidelberg, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.
Clinical Research, DePuy Synthes, Zuchwil, Switzerland.
Injury. 2017 Oct;48(10):2235-2241. doi: 10.1016/j.injury.2017.07.008. Epub 2017 Jul 10.
Despite the improvement of surgical techniques surgical site infections (SSIs) still remain clinically challenging in high risk patients undergoing osteosynthesis for tibia fractures. The use of an antibiotic coated implant might reduce the adhesion of bacteria on the implant surface and could therefore reduce the rate of implant-related infection or osteomyelitis. A gentamicin-coated tibia nail was evaluated in a prospective study. Four centers enrolled 100 patients (99 treated) with fresh open or closed tibia fractures, or for non-union revision surgery and followed them for 18 months. Data collected included infection events, radiographs, SF-12, EQ-5D, Iowa Ankle score, and the WOMAC questionnaire. Sixty-eight of the 99 treated patients suffered from a fresh fracture, while in 31 patients, the intramedullary nail was implanted for revision purposes, including non-unions due to infection. Fifteen (22%) of the fresh fractures were GA Type III. The follow-up rate was 87% and 82% at 12 months and 18 months, respectively. Deep surgical site infections occurred in 3 fresh fractures and two in revision surgeries. We did not observe any local or systemic toxic effects related to gentamicin during this study. The use of the antibiotic coated nail is an option in patients with a high infection risk, like open factures or infected non unions, in the prevention of the onset of an implant-related infection or osteomyelitis.
尽管手术技术有所改进，但对于接受胫骨骨折内固定术的高危患者而言，手术部位感染（SSIs）在临床上仍然具有挑战性。使用抗生素涂层植入物可能会减少细菌在植入物表面的附着，从而降低植入物相关感染或骨髓炎的发生率。一项前瞻性研究对庆大霉素涂层胫骨钉进行了评估。四个中心招募了100例患者（99例接受治疗），这些患者患有新鲜开放性或闭合性胫骨骨折，或因骨不连进行翻修手术，并对他们进行了18个月的随访。收集的数据包括感染事件、X光片、SF-12、EQ-5D、爱荷华踝关节评分和WOMAC问卷。99例接受治疗的患者中，68例患有新鲜骨折，而31例患者植入髓内钉是为了进行翻修，包括因感染导致的骨不连。15例（22%）新鲜骨折为GA III型。12个月和18个月时的随访率分别为87%和82%。3例新鲜骨折和2例翻修手术中发生了深部手术部位感染。在本研究中，我们未观察到与庆大霉素相关的任何局部或全身毒性作用。对于感染风险高的患者，如开放性骨折或感染性骨不连患者，使用抗生素涂层钉是预防植入物相关感染或骨髓炎发生的一种选择。
