PDF(Pubmed)
Abstract：
BACKGROUND: 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).
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05972603 . Registered on 2 August 2023.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05972603 . Registered on 2 August 2023.
摘要：
背景：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重要问题，将PJI预防研究放在首位。因此,本研究旨在比较在初次全髋关节(THA)和全膝关节置换术(TKA)患者中,联合使用聚维酮碘和外用万古霉素粉与单独使用聚维酮碘对PJI发生率的影响.
方法：前瞻性随机临床试验将在两家独立的、在下肢关节置换术方面有丰富经验的妇科医院进行。研究的材料将包括840名患者，这些患者转诊到医院进行初级THA或TKA。患者将被随机分为两组，在关节置换期间接受两种不同的干预措施。在第一组中,在伤口闭合之前，将使用聚维酮碘冲洗和连续外用万古霉素粉末。在第二组中，伤口闭合前仅使用聚维酮碘灌洗。主要结果将是基于关节置换术后90天内发生PJI的患者人数的PJI发病率。事件将使用组合方法确定，包括审查住院记录的再入院记录和对患者的后续电话访谈。将根据肌肉骨骼感染协会标准诊断感染。卡方检验将用于比较两个研究组之间的感染率。还将估计组间比较目的的风险和赔率比。还将进行医疗成本分析。
结论：一项随机临床试验将聚维酮碘冲洗和万古霉素粉剂联合使用与单独使用聚维酮碘冲洗在预防初次关节置换术后PJIs的效果进行了比较，这对于提高骨科手术知识至关重要。改善患者预后，并指导循证临床实践。
背景：ClinicalTrials.govNCT05972603。2023年8月2日注册。
方法：前瞻性随机临床试验将在两家独立的、在下肢关节置换术方面有丰富经验的妇科医院进行。研究的材料将包括840名患者，这些患者转诊到医院进行初级THA或TKA。患者将被随机分为两组，在关节置换期间接受两种不同的干预措施。在第一组中,在伤口闭合之前，将使用聚维酮碘冲洗和连续外用万古霉素粉末。在第二组中，伤口闭合前仅使用聚维酮碘灌洗。主要结果将是基于关节置换术后90天内发生PJI的患者人数的PJI发病率。事件将使用组合方法确定，包括审查住院记录的再入院记录和对患者的后续电话访谈。将根据肌肉骨骼感染协会标准诊断感染。卡方检验将用于比较两个研究组之间的感染率。还将估计组间比较目的的风险和赔率比。还将进行医疗成本分析。
结论：一项随机临床试验将聚维酮碘冲洗和万古霉素粉剂联合使用与单独使用聚维酮碘冲洗在预防初次关节置换术后PJIs的效果进行了比较，这对于提高骨科手术知识至关重要。改善患者预后，并指导循证临床实践。
背景：ClinicalTrials.govNCT05972603。2023年8月2日注册。
