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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 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.
研究组 & 干预措施
Xperience no rinse antimicrobial solution group
Experimental
XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure
干预措施: XPERIENCE Advanced Surgical Irrigation (Device)
Normal saline solution group
Active Comparator
Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure.
干预措施: Standard of Care Irrigation (Other)
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 (1)
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