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.
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（TKA）后假体周围感染（PJI）是一种毁灭性的并发症。在脊柱手术中，已证明吸入万古霉素粉末可降低感染率，但其在关节置换术中的作用仍存在争议。这项前瞻性随机对照试验旨在评估感内万古霉素预防原发性TKA后PJI的疗效。
方法：共有1,022名患者被随机分为研究组（n=507，在关节切开术闭合前接受2克伤口内万古霉素粉末）或对照组（n=515，无局部万古霉素），最少随访12个月。主要结果是PJI或手术部位感染（SSI）的发生率。次要结果包括相关的轻微并发症，如缝合脓肿，持续性伤口引流,和延迟拆线。评估的其他参数包括再手术率和肾毒性发生率。
结果：1,022例患者的总感染率为0.66%。研究组(N=1;0.2%)与对照组(N=3;0.58%)的PJI率无显著差异,P=.264。研究组(N=4;0.78%)和对照组(N=5;0.97%)的再手术率,研究组(N=1;0.2%)和对照组(N=2;0.38%)的SSI发生率相当.万古霉素队列，然而,与对照组(n=39;7.56%,P<0.05)。亚组分析显示，研究组中糖尿病患者的轻微伤口并发症发生率也较高（24[14.1%]对10[6.2%]；P<05]。多变量分析发现，使用万古霉素（比值比=1.64）和吸烟（比值比=1.85）与发生轻微伤口并发症的风险增加相关。未报告肾毒性病例。
结论：吸入万古霉素粉剂似乎不会降低原发性全膝关节置换术中的PJI/SSI率，包括高危人群。虽然从肾脏的角度来看是安全的，万古霉素与术后无菌伤口并发症的增加有关。吸入万古霉素可能不能有效降低原发性TKA中PJI的发生率。
方法：共有1,022名患者被随机分为研究组（n=507，在关节切开术闭合前接受2克伤口内万古霉素粉末）或对照组（n=515，无局部万古霉素），最少随访12个月。主要结果是PJI或手术部位感染（SSI）的发生率。次要结果包括相关的轻微并发症，如缝合脓肿，持续性伤口引流,和延迟拆线。评估的其他参数包括再手术率和肾毒性发生率。
结果：1,022例患者的总感染率为0.66%。研究组(N=1;0.2%)与对照组(N=3;0.58%)的PJI率无显著差异,P=.264。研究组(N=4;0.78%)和对照组(N=5;0.97%)的再手术率,研究组(N=1;0.2%)和对照组(N=2;0.38%)的SSI发生率相当.万古霉素队列，然而,与对照组(n=39;7.56%,P<0.05)。亚组分析显示，研究组中糖尿病患者的轻微伤口并发症发生率也较高（24[14.1%]对10[6.2%]；P<05]。多变量分析发现，使用万古霉素（比值比=1.64）和吸烟（比值比=1.85）与发生轻微伤口并发症的风险增加相关。未报告肾毒性病例。
结论：吸入万古霉素粉剂似乎不会降低原发性全膝关节置换术中的PJI/SSI率，包括高危人群。虽然从肾脏的角度来看是安全的，万古霉素与术后无菌伤口并发症的增加有关。吸入万古霉素可能不能有效降低原发性TKA中PJI的发生率。
