1Department of Neurological Surgery, Columbia University Medical Center.
2Department of Neurological Surgery, Weill Cornell Medical Center; and.
J Neurosurg. 2018 Dec 14;131(6):1966-1973. doi: 10.3171/2018.6.JNS172500. Print 2019 Dec 1.
Postoperative surgical site infections (SSIs) in neurosurgical patients carry a significant risk of increased morbidity and mortality. With SSIs accounting for approximately 20% of nosocomial infections and costing approximately $1.6 billion USD annually, there is a need for additional prophylaxis to improve current standards of care. Topical vancomycin is increasingly utilized in instrumented spinal and cardiothoracic procedures, where it has been shown to reduce the risk of SSIs. A randomized controlled trial assessing its efficacy in the general neurosurgical population is currently underway. Here, the authors report their initial impressions of topical vancomycin safety among patients enrolled during the 1st year of the trial.
This prospective, multicenter, patient-blinded, randomized controlled trial will enroll 2632 patients over 5 years. Here, the authors report the incidence of adverse events, the degree of systemic vancomycin absorption in treated patients, and pattern changes of antibiotic-resistant profiles of Staphylococcus aureus flora among patients enrolled during the 1st year.
The topical vancomycin treatment group comprised 257 patients (514 total enrolled patients), of whom 2 exhibited weakly positive serum levels of vancomycin (> 3.0 mg/dl). S. aureus was detected preoperatively in the anterior nares of 35 (18.1%) patients and the skin near the surgical site of 9 (4.7%). Colonization in the nares remained for many patients (71.4%) through postoperative day 30. The authors found a significant association between preoperative S. aureus colonization and postoperative colonization. Seven methicillin-resistant isolates were detected among 6 different patients. Two isolates were detected preoperatively, and 5 were de novo postoperative colonization. No adverse responses to treatment have been reported to date.
The authors' data indicate that the use of topical vancomycin is safe with no significant adverse effects and minimal systemic absorption, and no development of vancomycin-resistant microorganisms.Clinical trial registration no.: NCT02284126 (clinicaltrials.gov).
神经外科患者术后手术部位感染（SSI）会显著增加发病率和死亡率。SSI 约占医院感染的 20%，每年花费约 16 亿美元，因此需要额外的预防措施来改善当前的护理标准。局部万古霉素在器械性脊柱和心胸手术中越来越多地被使用，它已被证明可以降低 SSI 的风险。一项评估其在普通神经外科人群中疗效的随机对照试验正在进行中。在这里，作者报告了在试验的第 1 年中纳入的患者中局部万古霉素安全性的初步印象。
这是一项前瞻性、多中心、患者盲法、随机对照试验，将在 5 年内纳入 2632 名患者。在这里，作者报告了不良事件的发生率、治疗患者中系统万古霉素吸收的程度，以及纳入的患者中金黄色葡萄球菌菌群的抗生素耐药谱模式变化第 1 年。
局部万古霉素治疗组包括 257 名患者（514 名总入组患者），其中 2 名患者的血清万古霉素水平呈弱阳性（>3.0mg/dl）。35 名（18.1%）患者的前鼻腔和 9 名（4.7%）患者的手术部位附近皮肤术前检测到金黄色葡萄球菌。许多患者（71.4%）的鼻腔定植持续到术后 30 天。作者发现术前金黄色葡萄球菌定植与术后定植之间存在显著相关性。在 6 名不同的患者中检测到 7 株耐甲氧西林的分离株。其中 2 株分离株术前检出，5 株为术后新出现的定植。迄今为止，尚未报告治疗的不良反应。
作者的数据表明，局部万古霉素的使用是安全的，没有明显的不良反应，系统吸收最小，也没有产生耐万古霉素的微生物。临床试验注册号：NCT02284126（clinicaltrials.gov）。
