Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Rate of Post-operative Infection
研究概览
简要总结
Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.
详细描述
This study is a single blind prospective randomized trial. To measure and compare the effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and combination of gentamicin and cephazolin this study is designed.
The patients are grouped randomly in to two groups:
- Group1;intravenous cefazolin sodium
- Group2;topical gentamicin
- Group3:topical gentamicin and intravenous cefazolin sodium
As a control group we decided to use the data of control groups ( without any prophylactic agent usage ) of previous studies done in our clinic and medical data base reviews.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of inguinal hernia
排除标准
- •Femoral hernia
- •Emergency cases
研究组 & 干预措施
gentamicin
80 mg gentamicin topical application intraoperatively
干预措施: Gentamicin (Drug)
Cefazolin
Application of 1000 mg cefazolin intra venously 1 hour before surgery
干预措施: Cefazolin (Drug)
gentamicin and cefazolin
1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively
干预措施: Gentamicin and cefazolin (Drug)
结局指标
主要结局
Rate of Post-operative Infection
时间窗: within the first 30 days after surgery
Number of Infections in Each Study Arm
时间窗: within the 30 days after surgery
Patients were examined on postoperative 30 days for the presence of surgical site infection.
次要结局
未报告次要终点
研究者
Duray Seker
M.D. Surgery
Diskapi Teaching and Research Hospital