Orthopaedic and Trauma Surgery Department, Independent Public Healthcare Center in Rypin, Rypin, Poland.
Trauma and Orthopedic Surgery Department, Independent Public Healthcare Center in Myslenice, Myslenice, Poland.
Trials. 2024 Jul 10;25(1):468. doi: 10.1186/s13063-024-08306-3.
With the increasing number of joint replacement surgeries, periprosthetic joint infection (PJI) has become a significant concern in orthopedic practice, making research on PJI prevention paramount. Therefore, the study will aim to compare the effect of combined usage of povidone-iodine and topical vancomycin powder to the use of povidone-iodine alone on the PJI incidence rate in patients undergoing primary total hip (THA) and total knee arthroplasty (TKA).
The prospective randomized clinical trial will be conducted in two independent voivodeship hospitals with extensive experience in lower limb arthroplasties. The studied material will comprise 840 patients referred to hospitals for primary THA or TKA. The patients will be randomly allocated to two equal groups, receiving two different interventions during joint replacement. In group I, povidone-iodine irrigation and consecutively topical vancomycin powder will be used before wound closure. In group II, only povidone-iodine lavage irrigation will be used before wound closure. The primary outcome will be the incidence rate of PJI based on the number of patients with PJI occurrence within 90 days after arthroplasty. The occurrence will be determined using a combined approach, including reviewing hospital records for readmissions and follow-up phone interviews with patients. The infection will be diagnosed based on Musculoskeletal Infection Society criteria. The chi-square test will be used to compare the infection rates between the two studied groups. Risk and odds ratios for the between-groups comparison purposes will also be estimated. Medical cost analysis will also be performed.
A randomized clinical trial comparing the effect of combined usage of povidone-iodine irrigation and vancomycin powder to the use of povidone-iodine irrigation alone in preventing PJIs after primary arthroplasty is crucial to advancing knowledge in orthopedic surgery, improving patient outcomes, and guiding evidence-based clinical practices.
ClinicalTrials.gov NCT05972603 . Registered on 2 August 2023.
随着关节置换手术数量的增加，假体周围关节感染（PJI）已成为骨科实践中的一个重大关注点，因此研究 PJI 的预防措施至关重要。因此，本研究旨在比较聚维酮碘联合局部万古霉素粉与单独使用聚维酮碘对行初次全髋关节置换术（THA）和全膝关节置换术（TKA）患者 PJI 发生率的影响。
这是一项在两家具有丰富下肢关节置换经验的独立省级医院进行的前瞻性随机临床试验。研究材料将包括因初次 THA 或 TKA 转诊至医院的 840 名患者。患者将被随机分为两组，在关节置换过程中接受两种不同的干预措施。在 I 组中，在关闭伤口前使用聚维酮碘冲洗，然后局部使用万古霉素粉。在 II 组中，仅在关闭伤口前使用聚维酮碘冲洗。主要结局是 90 天内发生 PJI 的患者比例，通过回顾医院记录以确定再入院患者，并对患者进行随访电话访谈来确定。感染将根据肌肉骨骼感染协会的标准进行诊断。将使用卡方检验比较两组的感染率。还将估计两组之间的风险比和优势比。同时进行医疗成本分析。
比较初次关节置换术后联合使用聚维酮碘冲洗和万古霉素粉与单独使用聚维酮碘冲洗预防 PJI 的随机临床试验对于推进骨科手术知识、改善患者结局和指导基于证据的临床实践至关重要。
ClinicalTrials.gov NCT05972603。注册于 2023 年 8 月 2 日。
