NCT05577936撤回不适用
A Randomized Controlled Trial of the Next Science® XPERIENCE™ Advanced Surgical Irrigation Versus Standard of Care Irrigation Efficacy in Decreasing Bioburden in Primary Total Hip and Knee Arthroplasty Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Change in culture positive rates
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Xperience, a no rinse antimicrobial solution, on joint infection rates in patients undergoing total hip (THA) and total knee (TKA) arthoplasty surgery.
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
- 是
入选标准
- •Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
- •Willing to comply with all study-related procedures and be available for the duration of the study.
- •Provide signed and dated informed consent.
排除标准
- •Unable to provide signed and dated informed consent.
- •Unwilling or unable to comply with all study-related procedures.
- •Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
- •Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
- •Pregnant, planning to become pregnant, or nursing female subjects.
- •Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
- •Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
- •Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.
结局指标
主要结局
Change in culture positive rates
时间窗: Baseline (pre-irrigation) and post-irrigation approximately 3 minutes
Number of culture positive tissue samples
次要结局
- Deep Periprosthetic Joint Infection(90 days)
研究者
Cameron K. Ledford
Principal Investigator
Mayo Clinic
研究点 (2)
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