Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Composite wound complication within 30 days after cesarean delivery
研究概览
简要总结
The goal of this clinical trial is to evaluate whether local subcutaneous administration of gentamicin reduces the incidence of surgical site infection (SSI) following elective cesarean section. The study will also assess the safety of local gentamicin administration. The main questions this study aims to answer are:
- Does local subcutaneous administration of gentamicin reduce the rate of superficial and deep surgical site infections within 30 days after elective cesarean delivery?
- Are there differences between groups in postoperative complications, including wound healing, fever, need for additional antibiotic treatment, or hospital readmission?
Researchers will compare women who receive local subcutaneous gentamicin at the surgical site in addition to standard antibiotic prophylaxis to women who receive standard antibiotic prophylaxis alone.
Participants will:
- Undergo an elective cesarean section according to standard clinical practice
- Receive either local subcutaneous gentamicin administration or no local antibiotic administration, in addition to standard systemic antibiotic prophylaxis
- Be followed clinically for signs of surgical site infection and other postoperative complications during hospitalization and at follow-up visits up to 30 days after surgery
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
- 是
入选标准
- •Women aged 18 years and older.
- •Undergoing elective cesarean section.
- •Gestational age >= 24 weeks.
- •Planned postoperative follow-up of 30 days.
- •Eligible for standard antibiotic prophylaxis according to institutional protocol.
- •Able to provide informed consent.
排除标准
- •Known allergy of hypersensitivity to aminoglycosides.
- •Known allergy of hypersensitivity to systemic antibiotic prophylaxis agents.
- •Current or planned use of immunomodulatory or immunosuppressive therapy.
- •Requirement for therapeutic ( non- prophylactic) antibiotic treatment at the time of surgery.
- •Active infection or clinical condition requiring antibiotic treatment.
- •Inability or unwillingness to comply with study procedures or follow-up.
研究组 & 干预措施
Local subcutaneous gentamicin
Participants undergoing elective cesarean section who receive standard systemic antibiotic prophylaxis according to institutional protocol plus a single local subcutaneous administration of gentamicin at the surgical site.
干预措施: Gentamicin (Drug)
结局指标
主要结局
Composite wound complication within 30 days after cesarean delivery
时间窗: within 30 days after cesarean section
Occurrence of one or more postoperative wound complications within 30 days, including SSI, wound dehiscence, seroma requiring drainage, hematoma requiring intervention, wound-related antibiotic treatment, wound-related emergency department visit, or wound-related readmission.
postoperative surgical site infection
时间窗: within 30 days after cesarean section
次要结局
- Surgical site infection within 30 days after cesarean delivery(30 days after cesarean delivery)
研究者
Dr. Nadir Ganem
Principal Investigator
Western Galilee Hospital-Nahariya