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万古霉素粉末联合稀释聚维酮碘灌洗预防高风险全关节置换术后感染的三个月伤口并发症和感染率:一项多中心随机对照试验

The Three-Month Wound Complication and Infection Rates After Vancomycin Powder and Dilute Povidone-Iodine Lavage for Infection Prophylaxis in High-Risk Total Joint Arthroplasty: A Multicenter Randomized Controlled Trial.

作者信息

Saba Braden V, Higuera-Rueda Carlos A, Dundon John, Cooper H John, Dennis Douglas A, Long William J, Chen Antonia F, Schwarzkopf Ran

机构信息

Department of Orthopaedic Surgery, NYU Langone Health, New York, New York.

Department of Orthopaedic Surgery, Cleveland Clinic Weston Hospital, Weston, Florida.

出版信息

J Arthroplasty. 2025 Sep;40(9S1):S487-S494. doi: 10.1016/j.arth.2025.04.084. Epub 2025 May 9.

DOI:10.1016/j.arth.2025.04.084
PMID:40349869
Abstract

BACKGROUND

Periprosthetic joint infection (PJI) is a high-cost and extremely morbid complication following total joint arthroplasty; thus, developing a better understanding of perioperative infection prevention strategies is prudent. Literature is mixed regarding the efficacy of vancomycin powder and dilute povidone-iodine lavage, and limited on the combination thereof. To our knowledge, no prospective orthopedic clinical trials to date have evaluated the efficacy of local vancomycin powder, dilute povidone-iodine lavage, or a combination vancomycin-povidone-iodine protocol against normal saline irrigation.

METHODS

In a large, prospective, multicenter, randomized-controlled study, four distinct infection prevention strategies were implemented in high-risk total joint arthroplasty patients. Local vancomycin powder, dilute povidone-iodine solution, combined vancomycin-povidone-iodine protocol, and saline control were used. Primary outcomes included PJI, wound complications, revisions, emergency department visits, readmissions, and serious adverse events within 3 months of index surgery. Chi-square tests were used to compare incidence rates. The criteria used for the diagnosis of PJI were the International Consensus Meeting guidelines.

RESULTS

There were 821 total hip arthroplasty (THA) and 1,080 total knee arthroplasty (TKA) patients randomized into well-balanced study groups. In the THA and TKA cohorts, respectively, there were no statistically significant differences in rates of persistent wound drainage or dehiscence (P = 0.98, P = 0.95), cellulitis or abscess (P = 0.81, P = 0.51), 3-month infection rates (P = 0.14, P = 0.13), type of septic revisions performed (P = 0.51, P = 0.80), aseptic revision rates (P = 0.07, P = 0.90), emergency department visits (P = 0.61, P = 0.46), or readmissions (P = 0.78, P = 0.87) between the four treatment groups.

CONCLUSIONS

There were no statistically significant differences in PJI or other surgical outcomes following THA or TKA among the study groups. Therefore, the use of such prophylactic measures, including povidone-iodine and vancomycin powder in high-risk patients, can be left up to the surgeon or hospital discretion.

摘要

背景

人工关节周围感染(PJI)是全关节置换术后一种成本高昂且危害极大的并发症;因此,深入了解围手术期感染预防策略是明智之举。关于万古霉素粉末和稀释聚维酮碘灌洗的疗效,文献报道不一,且关于两者联合使用的研究有限。据我们所知,迄今为止尚无前瞻性骨科临床试验评估局部使用万古霉素粉末、稀释聚维酮碘灌洗或万古霉素 - 聚维酮碘联合方案相对于生理盐水冲洗的疗效。

方法

在一项大型、前瞻性、多中心、随机对照研究中,对高危全关节置换患者实施了四种不同的感染预防策略。使用了局部万古霉素粉末、稀释聚维酮碘溶液、万古霉素 - 聚维酮碘联合方案以及生理盐水对照。主要结局包括初次手术后3个月内的人工关节周围感染、伤口并发症、翻修手术、急诊就诊、再入院以及严重不良事件。采用卡方检验比较发生率。人工关节周围感染的诊断标准采用国际共识会议指南。

结果

共有821例全髋关节置换术(THA)患者和1080例全膝关节置换术(TKA)患者被随机分配到均衡的研究组中。在THA和TKA队列中,四个治疗组在持续伤口引流或裂开发生率(P = 0.98,P = 0.95)、蜂窝织炎或脓肿发生率(P = 0.81,P = 0.51)、3个月感染率(P = 0.14,P = 0.13)、感染性翻修手术类型(P = 0.51,P = 0.80)、无菌性翻修率(P = 0.07,P = 0.90)、急诊就诊率(P = 0.61,P = 0.46)或再入院率(P = 0.78,P = 0.87)方面均无统计学显著差异。

结论

研究组之间在THA或TKA后的人工关节周围感染或其他手术结局方面无统计学显著差异。因此,对于高危患者,包括使用聚维酮碘和万古霉素粉末在内的此类预防措施的使用可由外科医生或医院自行决定。

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