Endoscopic Carpal Tunnel Release, Infection Incidence, and Prophylactic Antibiotics: Indicated or Kick the Habit?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Number of Participants With Surgical Site Infection
研究概览
简要总结
This is a clinical trial to determine how effective antibiotics administered prior to endoscopic carpal tunnel release surgery are in preventing surgical site infections.
详细描述
Study participants will be randomized to a prophylactic IV antibiotic treatment arm (Vancomycin or Cefazolin) or a placebo IV saline solution. Subjects will be monitored following surgery for surgical site infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Principal investigator, co-investigators, and participants are blinded to study intervention
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
- •High probability (>12 points) on the Carpal Tunnel-6 diagnostic aide
- •Recommendation for carpal tunnel release
- •Capable of providing informed consent/LAR to act on subject's behalf
排除标准
- •Patients allergic to both penicillin/cephalosporins and vancomycin
- •Patient immobilized with splint or cast
- •Unwilling unable to provide informed consent
- •Children under the age of 18
研究组 & 干预措施
Vancomycin
干预措施: Vancomycin (Drug)
Cefazolin
干预措施: Cefazolin (Drug)
Saline
干预措施: Saline Solution (Drug)
结局指标
主要结局
Number of Participants With Surgical Site Infection
时间窗: 6 weeks post-operative
Definitive diagnosis of infection of surgical site -Definitive diagnosis of infection of surgical site -wounds determined to be infected will be divided into superficial or deep infections and treated according to the standard of care at WellSpan health.
次要结局
- Number of Participants With Diabetes Diagnosis and Surgical Site Infection(6 weeks post-operative)
- Number of Participants With Anemia Diagnosis and Surgical Site Infection(6 weeks post-operative)
- Number of Participants With Surgical Site Infection and a History of Arthroplasty(2 weeks post-operative)
- Number of Participants With Surgical Site Infection and History of Arthroplasty(6 weeks post-operative)
- Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection(6 weeks post-operative)
- Number of Participants With Surgical Site Infections That Use Tobacco(6 weeks post-operative)
- Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection(6 weeks post-operative)
- Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection(6 weeks post-operative)
- Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release(6 weeks post-operative)
- Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release(6 weeks post-operative)
- Time From Last Cortisone Injection(6 weeks post-operative)
- Acuity of Carpal Tunnel Syndrome(6 weeks post-operative)
研究者
Richard C Trevino, MD
Orthopedic Surgeon -WellSpan Orthopedics
WellSpan Health