Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- C Acnes Presence
研究概览
简要总结
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study.
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
- •Ault patients requiring Total Shoulder Arthroplasty
排除标准
- •Age younger than 18 years
- •History of shoulder infection
- •Antibiotic therapy within 2 weeks of surgery
- •Cortisone infiltration within 3 months prior to surgery
- •Allergy to CHG
- •Diagnosis of rheumatoid arthritis
- •Immunocompromised patients
结局指标
主要结局
C Acnes Presence
时间窗: Cultures take during surgery and analyzed over 21 days post surgery
The primary outcome of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2)rimary objecti
次要结局
- Shoulder Range of Motion (ROM)(Pre-operation, 3, 6, 12, & 24 Months post-operation,)
- American Shoulder and Elbow Surgeons Patient Reported Outcome Measure(Pre-operation, 3, 6, 12, & 24 Months post-operation,)