Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Reduction WBC
研究概览
简要总结
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
详细描述
This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage.
This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I & D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is undergoing I & D or reoperation (revision) surgery for an infected primary TKA.
- •Patient is 18 years of age or greater.
- •Patient is skeletally mature.
- •Occurs within 30 days of the operation or within 1 year or more if an implant is present
- •Involves deep soft tissues (e.g., fascia and/or muscle) of the incision
- •Patient is willing and able to provide written informed consent.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol
排除标准
- •Patients will be excluded from this study if:
- •Patient is unwilling or unable to give consent or to comply with the follow-up program.
- •Known sensitivity or allergic reaction to benzalkonium chloride one or more of the solvent, chelating agent, or buffer in the solution
- •Multiple (>1) infected implants
- •Medically unfit for irrigation & debridement procedure
- •Pregnancy
- •The patient is:
- •mentally incompetent or unable to understand what participation in the study entails
- •anticipated to be non-compliant.
结局指标
主要结局
Reduction WBC
时间窗: Intraoperative
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage
次要结局
- Bacteria Identification(One Week)