Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 864
- 试验地点
- 1
- 主要终点
- Postoperative Infection Rate
研究概览
简要总结
This study compares the efficacy of a single intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides), alone versus both intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides) and postoperative oral dose of "cephalexin" or "clindamycin" use in nasal surgery.
详细描述
The study will consist of 2 treatment arms:
Treatment arm A: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
Treatment arm B: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg every 4 hours or "clindamycin" 150mg every 6 hours, for a duration of three days.
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
- 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
- •Adult patients (aged 18years and older)
排除标准
- •Prior rhinoplasty
- •Any exogenous (non-nasal) grafts/implants
- •Immune deficiency (DM, meds, other)
- •History of radiotherapy to nose
研究组 & 干预措施
Treatment arm A
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
干预措施: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. (Drug)
Treatment arm B
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg every 4 hours or "clindamycin" 150mg every 6 hours, for a duration of three days.
干预措施: Intra-operative single dose (iv) of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg (every 4 hours) or "clindamycin" 150mg(every 6 hours) for 3 days (Drug)
结局指标
主要结局
Postoperative Infection Rate
时间窗: Seven days
Postoperatively, infection rates between treatment arms will be compared
次要结局
未报告次要终点
研究者
Sam P. Most
Professor and Chief, Division of Facial Plastic and Reconstructive Surgery
Stanford University