The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients: A Randomized Control Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Complication Rate
研究概览
简要总结
This study aims to investigate the impact of antibiotic prophylaxis on reducing wound infection rates following open repair of primary elective groin hernias in high-risk patients.
详细描述
This study will be a randomized controlled trial involving high-risk patients undergoing open repair of primary elective groin hernias. Participants will be randomized into two groups: one receiving antibiotic prophylaxis and the other serving as the control group. The study will assess the incidence of wound infections postoperatively in both groups to determine the effectiveness of antibiotic prophylaxis in lowering infection rates.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer to participate in the study.
- •Elderly patients aged over 60 years.
- •Patients with Diabetes.
- •Or obese patients with a BMI greater than
- •Or immunocompromised patients.
- •Or American Society of Anesthesiologists (ASA) physical status classification 2 or more, with a history of more than 10 years.
排除标准
- •Non-cooperative patients for regular follow-up.
- •Therapeutic Indication for.
研究组 & 干预措施
Prophylaxis antibiotics Group
Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.
干预措施: Cefazolin 1000 MG (Drug)
结局指标
主要结局
Overall Complication Rate
时间窗: up to 30 days after the surgery.
Overall complication rate; graded by the Clavien- Dindo complications classification system
Wound infection/ Surgical site infection
时间窗: up to 30 days after the surgery.
has been defined and classified as superficial incisional, deep incisional, and organ/ space_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017).
次要结局
- Hospital stay(up to 30 days after the surgery.)
- Mortality Rate(up to 30 days after the surgery.)
研究者
Ahmad Yamen Arnaout
Principal Investigator
University of Aleppo