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临床试验/NCT06468163
NCT06468163尚未招募不适用

Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery: A Prospective, Randomized Controlled Trial Study

First Affiliated Hospital of Xinjiang Medical University0 个研究点目标入组 200 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Infection control rate

研究概览

简要总结

Prosthetic Joint Infection (PJI) is a severe complication following joint replacement surgery, imposing significant economic and health burdens on patients. For acute PJI, the DAIR (Debridement, Antibiotics, and Implant Retention) procedure is a necessary and effective treatment method, as it effectively clears the infection while preserving the prosthesis, thereby avoiding more complex surgical interventions. However, the practice of using drainage tubes postoperatively is controversial. Some studies suggest that drainage tubes may increase the risk of infection, while other literature indicates no statistically significant difference in infection risk associated with their use.In this context, Professor Li Cao's team at Xinjiang Medical University has improved the traditional DAIR procedure by incorporating long-term local antibiotic injections post-surgery, achieving positive results. Despite this, the specific method of antibiotic injection, particularly whether to use a drug infusion tube, remains under debate. The use of an infusion tube can reduce patient discomfort, shorten the local disinfection process, and theoretically decrease the time the incision is exposed to the external environment, potentially lowering the infection risk. However, the validity of these theoretical assumptions needs further confirmation through high-level scientific research. This study aims to evaluate whether there are differences in joint function recovery, changes in blood infection markers, and the incidence of postoperative complications between using and not using an infusion tube for local antibiotic injection after knee DAIR surgery. To assess the value of the infusion tube in local antibiotic injection post-knee DAIR surgery, a randomized controlled trial (RCT) will be conducted. Eligible patients will be randomly assigned to the infusion tube group (experimental group) or the non-infusion tube group (control group). The study will prospectively collect basic information, joint function scores, blood infection markers, and postoperative complication data from both groups, including patient age, gender, educational background, and postoperative blood test results. Ultimately, the RCT aims to demonstrate the therapeutic efficacy of the infusion tube method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old, gender is not limited;
  • Meet the diagnostic criteria for DAIR surgery of artificial knee joint;
  • Receiving knee DAIR surgery;
  • Voluntary and signed informed consent.

排除标准

  • Patients with chronic PJI infection undergoing total knee revision;
  • Patients with severe knee joint infection who cannot undergo artificial joint replacement;
  • Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
  • periprosthesis infection after multiple joint replacement;
  • Active infection at the site of intravenous or joint injection;
  • long-term use of anticoagulants or antiplatelet drugs due to other diseases;
  • Have sepsis or positive blood culture within the last 30 days;
  • Radiotherapy and chemotherapy are required due to neoplastic diseases;
  • Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
  • severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
  • Have a history of drug abuse;
  • Treatment of bone marrow or other transplants with immunosuppressive drugs;
  • Pregnant, parturient and lactating women;
  • Participating in other clinical trials;
  • Researchers believe that other reasons are not appropriate for clinical trial participants.

结局指标

主要结局

Infection control rate

时间窗: Two year after surgery

Infection control rate

Re-operation rate

时间窗: Two year after surgery

Re-operation rate

Time between infection recurrence

时间窗: Two year after surgery

Time between infection recurrence

次要结局

  • C-reactive protein (CRP)(One day before surgery and one day after surgery)
  • Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)(One day before surgery, three month after surgery)
  • White blood cell count(One day before surgery and one day after surgery)
  • Erythrocyte sedimentation rate (ESR)(One day before surgery and one day after surgery)
  • Serum Creatinine(One day before surgery and one day after surgery)
  • American Knee Society Score (AKS score)(One day before surgery and two years after surgery)
  • Visual Analog Scale score(One day before surgery and two years after surgery)
  • X-ray(One day before surgery and two years after surgery)
  • Synovial fluid white blood count(One day before surgery and one day after surgery)
  • Polymorphonuclear neutrophil percentage in synovial fluid (SF-PMN)(One day before surgery and one day after surgery)
  • Alanine Aminotransferase (ALT)(One day before surgery and one day after surgery)
  • Aspartate Aminotransferase (AST)(One day before surgery and one day after surgery)
  • Blood Urea Nitrogen (BUN)(One day before surgery and one day after surgery)

研究者

发起方
First Affiliated Hospital of Xinjiang Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Long Hua

Doctor

First Affiliated Hospital of Xinjiang Medical University

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