PDF(Pubmed)
Abstract：
Background Applying topical vancomycin has shown a decrease in the likelihood of surgical site infections (SSIs) in surgeries linked to a heightened risk of severe and resistant infections. Nevertheless, the effectiveness of this prophylactic approach has not been assessed in open ankle surgeries with internal fixation. Objective This study aimed to assess whether topical vancomycin diminishes the risk of SSI in patients with ankle fractures undergoing open reduction with internal fixation. Methods A randomized, controlled, double-blind clinical trial was carried out. Patients were divided into two groups in a 1:1 ratio. The control group received the standard prophylactic treatment with IV cephalothin 1 g, while the intervention group was administered topical vancomycin (1 g) in addition to the standard prophylactic treatment. The main outcomes were the SSI rates at 14 days, 28 days, and three months post-surgery, based on relevant clinical signs and laboratory tests. Results One hundred thirty-two patients were randomized (51.2% female), with 66 subjects included in each intervention arm. A total of 97.7% of them completed the study. Both groups were homogeneous in baseline characteristics. There were two SSIs in both the vancomycin group (3.3%) and the control group (3.5%), with no statistical differences (p = 0.945). The microorganisms isolated as causal agents were Staphylococcus aureus and Acinetobacter baumannii. By the three-month follow-up, no infections were noted in both intervention groups. Conclusion These results indicate that the topical administration of vancomycin may not represent an advantage in preventing SSI in ankle fractures requiring open reduction with internal fixation at the three-month postoperative stage.
摘要：
背景技术局部应用万古霉素已显示手术中手术部位感染(SSIs)的可能性降低,这与严重和耐药性感染的风险增加有关。然而，这种预防性方法的有效性尚未在带内固定的开放踝关节手术中得到评估.目的本研究旨在评估万古霉素是否可以降低踝关节骨折切开复位内固定患者的SSI风险。方法随机,控制,进行了双盲临床试验。患者以1：1的比例分为两组。对照组接受静脉注射头孢菌素1g的标准预防性治疗，而干预组除标准预防性治疗外，还外用万古霉素（1g）。主要结果是14天的SSI率，28天,手术后三个月，基于相关的临床体征和实验室检查。结果132例患者被随机分组（51.2%为女性），每个干预组中包括66名受试者。其中97.7%完成了研究。两组基线特征均相同。万古霉素组（3.3％）和对照组（3.5％）均有两种SSIs，无统计学差异(p=0.945)。分离为病原体的微生物是金黄色葡萄球菌和鲍曼不动杆菌。通过三个月的随访，两组均未发现感染.结论这些结果表明，万古霉素的局部给药在术后三个月需要切开复位内固定的踝关节骨折中预防SSI可能没有优势。
