Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of Postoperative Infections
研究概览
简要总结
Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections. As an anaerobe, it usually needs a prolonged culture incubation time of up to 14 days for growth and the association between implant surgery and C. acnes infection is not always obvious. Unfortunately, prolonged incubation also increases the risk of false positive cultures in isolating organisms that may exist as a result of contamination. Given high rates of positive C. acnes cultures in cases of both primary and revision shoulder surgery, the ramifications of positive C. acnes cultures for clinical decision making remains uncertain.
The purpose of this study is to prospectively study the efficacy and side-effect profile of surgical treatment plus an oral antibiotic regiment for shoulder PJI with indolent organisms (C. acnes and CNS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •all patients undergoing single-stage revision arthroplasty with all implants exchanged,
- •all patients undergoing single-stage revision arthroplasty with some implants retained,
- •all patients undergoing explantation of a shoulder arthroplasty and placement of an antibiotic spacer
排除标准
- •patients with polymicrobial infection,
- •patients with infection by organisms other than P. acnes or Coagulase Negative Staphylococcus,
- •patients with clinical suspicion of infection but negative cultures,
- •patients with no preoperative or intraoperative signs of infection and only 1 positive culture.
研究组 & 干预措施
Revision Total Shoulder Arthroplasty
Routine cultures are taken at the time of surgery. All patients are seen by an Infectious Disease Specialist and placed on 2 weeks oral doxycycline 100 mg (or alternative based on allergy or sensitivity) pending culture results.
干预措施: Doxycycline 100 MG Oral Tablet (Drug)
结局指标
主要结局
Rate of Postoperative Infections
时间窗: 1 year
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics after revision shoulder surgery versus those treated with intravenous antibiotics after surgery
次要结局
未报告次要终点