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经皮加压钢板与解剖钢板治疗胫骨近端骨折的前瞻性随机对照研究。

Efficacy of Intrawound Vancomycin in Prevention of Periprosthetic Joint Infection After Primary Total Knee Arthroplasty: A Prospective Double-Blinded Randomized Control Trial.

机构信息

Sunshine Bone and Joint Insitute, KIMS-Sunshine Hospitals, Hyderabad, India.

Division of Arthroplasty, Rothman Orthopedics at Advent Health, Orlando, Florida.

出版信息

J Arthroplasty. 2024 Jun;39(6):1569-1576. doi: 10.1016/j.arth.2024.01.003. Epub 2024 Apr 10.

Abstract

BACKGROUND

Periprosthetic joint infection (PJI) after total knee arthroplasty (TKA) is a devastating complication. Intrawound vancomycin powder has been shown to reduce infection rates in spine surgery, but its role in arthroplasty remains controversial. This prospective randomized control trial aimed to evaluate the efficacy of intrawound vancomycin in preventing PJI after primary TKA.

METHODS

A total of 1,022 patients were randomized to the study group (n = 507, who received 2 grams intrawound vancomycin powder before arthrotomy closure) or to the control group (n = 515, no local vancomycin) with a minimum follow-up of 12-months. The primary outcome was the incidence of PJI or surgical site infection (SSI). Secondary outcomes included associated minor complications such as stitch abscess, persistent wound drainage, and delayed stitch removal. Other parameters evaluated include reoperation rates and incidences of nephrotoxicity.

RESULTS

The overall infection rate in 1,022 patients was 0.66%. There was no significant difference in PJI rate in the study group (N = 1; 0.2%) versus the control group (N = 3; 0.58%), P = .264. Reoperation rates in the study group (N = 4; 0.78%) and control (N = 5; 0.97%), and SSI rates in the study (N = 1; 0.2%) and control groups (N = 2; 0.38%) were comparable. The Vancomycin cohort, however, demonstrated a significantly higher number of minor wound complications (n = 67; 13.2%) compared to the control group (n = 39; 7.56%, P < .05). Subgroup analysis showed diabetics in the study group to also have a higher incidence of minor wound complications (24 [14.1%] versus 10 [6.2%]; P < 05]. Multivariate analyses found that vancomycin use (odds ratio = 1.64) and smoking (odds ratio = 1.85) were associated with an increased risk of developing minor wound complications. No cases of nephrotoxicity were reported.

CONCLUSIONS

Intrawound vancomycin powder does not appear to reduce PJI/SSI rate in primary total knee arthroplasties, including high-risk groups. Although safe from a renal perspective, intrawound vancomycin was associated with an increase in postoperative aseptic wound complications. Intrawound vancomycin may not be effective in reducing the rate of PJI in primary TKA.

摘要

背景

全膝关节置换术后假体周围关节感染(PJI)是一种破坏性的并发症。局部使用万古霉素粉末已被证明可降低脊柱手术的感染率,但在关节置换术中的作用仍存在争议。本前瞻性随机对照试验旨在评估关节切开术闭合前局部使用万古霉素粉末预防初次 TKA 后 PJI 的疗效。

方法

共有 1022 名患者被随机分为研究组(n=507,接受 2 克局部万古霉素粉末)或对照组(n=515,无局部万古霉素),随访时间至少 12 个月。主要结局是 PJI 或手术部位感染(SSI)的发生率。次要结局包括与手术相关的轻微并发症,如缝线脓肿、持续伤口引流和延迟拆线。评估的其他参数包括再次手术率和肾毒性发生率。

结果

1022 名患者的总感染率为 0.66%。研究组(N=1;0.2%)与对照组(N=3;0.58%)的 PJI 发生率无显著差异,P=0.264。研究组(N=4;0.78%)和对照组(N=5;0.97%)的再次手术率和 SSI 发生率相似。然而,万古霉素组(n=67;13.2%)与对照组(n=39;7.56%)相比,出现明显更多的轻微伤口并发症,P<0.05。亚组分析显示,研究组中的糖尿病患者也有更高的轻微伤口并发症发生率(24[14.1%]与 10[6.2%];P<0.05)。多变量分析发现,万古霉素使用(比值比=1.64)和吸烟(比值比=1.85)与轻微伤口并发症的发生风险增加相关。未报告肾毒性病例。

结论

局部使用万古霉素粉末似乎不能降低初次全膝关节置换术(包括高危人群)的 PJI/SSI 发生率。虽然从肾脏角度来看是安全的,但局部使用万古霉素与术后无菌性伤口并发症增加有关。局部使用万古霉素可能不能有效降低初次 TKA 后 PJI 的发生率。

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