Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 936
- 试验地点
- 3
- 主要终点
- infection rate
研究概览
简要总结
A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult that meets at least one of the below criteria at time of screening:
- •American Society of Anesthesiologists (ASA) 3 2
- •Patient with functional limitations as a result of disease1:
- •Poorly treated hypertension
- •Poorly treated diabetes
- •Chronic renal failure
- •Bronchospastic disease
- •Disease with intermittent exacerbations
- •Stable angina
- •Implanted pacemaker
- •Known history as an active nicotine use (smoker)
- •Known history of uncontrolled diabetes mellitus (HgbA1C > 7.0)
- •Known history of end stage organ disease
- •Known history of inflammatory arthritis and currently on rheumatological medication (DMARDs)
- •Known history of current active cancer treatment (chemotherapy)
- •Venous Disease (Surgical Risk Calculator from ACS-NSQIP)
- •Charleston Comorbidity Score > 2
- •Elixhauser Score >11
- •Age 65 or older
- •Subject is scheduled to primary joint replacement.
- •Subject is willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study.
- •Subject has understood, signed, and dated the informed consent form.
排除标准
- •Unable to provide signed and dated informed consent.
- •Unable or unwilling to comply with all study-related procedures.
- •Known history of 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)
- •Subject has contraindications to general anesthesia
- •Any subject positive for Covid-19 virus at time of surgical screening
- •Subjects have evidence of prolonged QT segment, per EKG.
- •Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
研究组 & 干预措施
The Next Science treatment
The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time
干预措施: No-Rinse Solution (NS) (Other)
Standard of Care
Saline irrigation
干预措施: Saline irrigation (Other)
结局指标
主要结局
infection rate
时间窗: at 90 days
Joint infection rate after surgery
次要结局
- QT prolongation(up to 24 hours (from the time of irrigation to closure))
研究者
Giles Scuderi
Orthopaedic Surgery, Joint Reconstruction
Northwell Health