Antibiotic Prophylaxis in Prosthetic Breast Reconstructions
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- surgical site infection
研究概览
简要总结
The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All criteria should be present:
- •Signing an informed consent form
- •Reconstructive breast surgery
- •One drain or more remained after surgery -
排除标准
- •Age < 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state
研究组 & 干预措施
short antibiotic course
Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery
干预措施: Short antibiotic course (standard of care) (Drug)
Prolonged antobiotic treatment
Intravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains
干预措施: Prolonged antibiotic treatment (Drug)
结局指标
主要结局
surgical site infection
时间窗: 1 year
The percentage and number of surgical site infections assessed according to the NNIS criteria up to one year after reconstructive breast surgery will be compared between the two groups
次要结局
未报告次要终点
研究者
Dr. Yasmin Maor
Head of the infectious didease service to the hospitalized patient, infectious disease unit
Sheba Medical Center