Prophylactic Antibiotics in Groin Hernioplasty: A Prospective Cohort Study on the Prevention of Surgical Site Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Site Infection (SSI)
研究概览
简要总结
The role of prophylactic antibiotics in preventing surgical site infections (SSI) for clean procedures like groin hernia repair remains controversial. This study aimed to evaluate the association between antibiotic prophylaxis and SSI rates in a real-world clinical setting and to identify independent risk factors for SSI. The study prospectively followed 100 male patients undergoing elective open groin hernioplasty. Patients were categorized based on the surgeon's decision into two groups: those who received a single dose of intravenous cefazolin (Antibiotic Group) and those who did not (No Antibiotic Group). The main outcome was the rate of SSI within 30 days of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 17-80 years) undergoing primary open groin hernioplasty.
- •Provided written informed consent.
排除标准
- •Recurrent, emergency, or complicated (e.g., incarcerated, strangulated) hernias.
- •Laparoscopic repairs.
- •Known immunosuppression, ongoing antibiotic therapy, or a known allergy to cefazolin.
- •Refusal to participate.
研究组 & 干预措施
Antibiotic Group
Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision.
干预措施: Cefazolin (Drug)
结局指标
主要结局
Incidence of Surgical Site Infection (SSI)
时间窗: Within 30 days post-surgery
The rate of surgical site infection diagnosed within 30 days of surgery, based on Centers for Disease Control and Prevention (CDC) clinical criteria (e.g., purulent discharge, erythema, localized pain or swelling).
次要结局
- Independent Risk Factors for Surgical Site Infection (SSI)(From baseline through 30 days post-surgery)
研究者
Haitham Mohammed Jowah
Lecturer
Sana'a University