NCT07599865招募中2 期
Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
研究概览
简要总结
Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50/50 in the active and control groups). Subjects in the active group will receive a local bolus injection of antibiotics and ultrasound-active microbubbles within 24 hours of their revision surgery. The fundamental hypothesis is that a decrease in re-infection rates of at least 24% can be achieved in the active group relative to controls.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age
- •Be medically stable
- •If female of child-bearing potential, must have a negative pregnancy test
- •Be conscious and able to comply with study procedures
- •Have read and signed the IRB-approved Informed Consent form for participating in the study
- •For Cohort 1, be scheduled for one- or two-stage exchange arthroplasty revision surgery for PJI of the knee
- •For Cohort 2, be scheduled for DAIR revision surgery for PJI of the knee
排除标准
- •Females who are pregnant or nursing
- •Patients currently on chemotherapy requiring systemic infusion treatment
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
- •Patients with a history of anaphylactic allergy to perflutren or any other components of Definity
- •Patients with a history of failed one- or two-stage revision for infection
- •Patients for which placement of a surgical drain is contraindicated
- •Patients in protected classes (e.g., prisoners)
研究者
研究点 (5)
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