NCT04707092Unknown4 期
Use of Preoperative and Postoperative Antimicrobial Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups.
One group will receive a single treatment with an antibiotic at induction
The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic
详细描述
- Patients will be asked to participate in the study.
- Randomization
- Surgery
- Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation
- Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Willing to participate in the study
- •Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)
排除标准
- •multiple allergies to antibiotic substances
- •therapy with an antibiotic substance within the last 6 weeks
- •prior radiation to the head and neck patients undergoing revision surgery
- •Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection
研究组 & 干预措施
Antibiotic at induction
Experimental
Patients will receive one single dose of Antibiotic at induction
干预措施: Antibiotic (Drug)
Antibiotic one week
Experimental
Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic
干预措施: Antibiotic (Drug)
结局指标
主要结局
Adverse events
时间窗: 1 month
Side effects from treatment with antibiotics
次要结局
- Infection of surgical site (immediate)(1 month)
- Infection of surgical site (long term)(2 years)
研究者
研究点 (1)
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