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局部万古霉素是否可行?一项随机对照试验,旨在确定与标准术后抗生素相比,局部使用万古霉素粉末预防全膝关节置换术后感染的安全性。

Is Topical Vancomycin an Option? A Randomized Controlled Trial to Determine the Safety of the Topical Use of Vancomycin Powder in Preventing Postoperative Infections in Total Knee Arthroplasty, as Compared With Standard Postoperative Antibiotics.

机构信息

Brant Community Healthcare System, Pharmacy, Brantford, Canada; University of Waterloo, Pharmacy, Waterloo, Canada.

Brant Community Healthcare System, Orthopaedics, Brantford, Canada.

出版信息

J Arthroplasty. 2023 Aug;38(8):1597-1601.e1. doi: 10.1016/j.arth.2023.01.040. Epub 2023 Feb 2.

Abstract

BACKGROUND

The demand for total knee arthroplasties (TKAs) is expected to rise in the coming decades, increasing the burden of periprosthetic joint infections (PJIs). The use of intrawound vancomycin powder (VP) has proven to be effective in reducing the incidence of PJIs after spinal surgery. That said, its effectiveness in TKA remains unclear. This trial aims to examine the efficacy of intrawound vancomycin powder first versus standard postoperative antibiotics in preventing PJIs after TKA.

METHODS

This study was a double-blinded, noninferiority, randomized controlled trial. All participants received standard preoperative intravenous (IV) antibiotics (Cefazolin/Vancomycin) within 60 minutes of skin incision. Patients in the treatment group received 1 gram of VP applied intraoperatively by the orthopedic surgeon (500 mg directly on the prosthesis, 500 mg above the closed joint capsule). These patients did not receive postoperative antibiotics. Patients in the control group received standard postoperative IV antibiotics. The primary outcome was the incidence of acute surgical site infection within 42 days of procedure.

RESULTS

There were 80 patients randomized to the treatment group and 85 patients randomized to the control. Groups were matched with respect to baseline characteristics, including average age (66 versus 64), BMI (35.7 versus 33.4), and diabetics (16 versus 13). The trial was halted at 1 year as a significantly greater proportion (P = .03) of patients in the treatment group (n = 3, 3.75%) were diagnosed with PJIs compared to the control (n = 0).

CONCLUSION

Our trial demonstrated the intrawound application of VP to be inferior to standard postoperative IV antibiotics in reducing the incidence of PJIs after TKA.

摘要

背景

在未来几十年中,全膝关节置换术(TKA)的需求预计会增加,从而增加了假体周围关节感染(PJI)的负担。研究表明,围手术期使用万古霉素粉末(VP)可有效降低脊柱手术后 PJI 的发生率。然而,其在 TKA 中的有效性尚不清楚。本试验旨在研究 TKA 中应用伤口内万古霉素粉末与标准术后抗生素相比预防 PJI 的效果。

方法

这是一项双盲、非劣效性、随机对照试验。所有参与者均在皮肤切开后 60 分钟内接受标准术前静脉(IV)抗生素(头孢唑林/万古霉素)治疗。治疗组患者在骨科医生的操作下于术中使用 1 克 VP,(500 毫克直接应用于假体,500 毫克置于闭合的关节囊上方)。这些患者术后不接受抗生素治疗。对照组患者接受标准术后 IV 抗生素治疗。主要结局为术后 42 天内急性手术部位感染的发生率。

结果

80 名患者被随机分配至治疗组,85 名患者被随机分配至对照组。两组在基线特征方面匹配,包括平均年龄(66 岁比 64 岁)、BMI(35.7 比 33.4)和糖尿病患者比例(16 比 13)。试验在 1 年时因治疗组(n=3,3.75%)中有更多患者(n=3,3.75%)被诊断为 PJI 而显著提前停止(P=0.03)。

结论

我们的试验表明,与标准术后 IV 抗生素相比,TKA 中伤口内应用 VP 降低 PJI 发生率的效果较差。

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