Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
The goal of this clinical trial is to learn if the use of prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The main question it aims to answer is:
• Does the use of intravenous prophylactic antibiotics or antimicrobial-coated sutures significantly reduce the occurrence of surgical site infection in children undergoing open groin surgeries?
Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children.
Participants will:
- Undergo open groin surgery with either the use of intravenous prophylactic antibiotic or antimicrobial-coated sutures or without antibiotic use
- Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection.
详细描述
The aim of this clinical trial is to learn if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The specific objectives are:
- To determine the rate of surgical site infection in paediatric groin surgeries without antibiotics
- To determine the rate of surgical site infection in paediatric groin surgeries with the use of intravenous prophylactic antibiotics
- To determine the rate of surgical site infection in paediatric groin surgeries with the use of antimicrobial-coated sutures.
- To compare the rates of surgical site infection in paediatric groin surgeries without antibiotics, with the use of intravenous prophylactic antibiotics and use of antimicrobial-coated sutures
Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children.
It shall be a double blinded randomized controlled trial
Eligible Participants will:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with clinical conditions requiring daycase open groin surgery
排除标准
- •Re-operations
- •Immunocompromised patients
- •Malnourished patients
- •Complicated groin pathologies e,g obstructed inguinal hernia
- •History of antibiotic usage in the last seven days
研究组 & 干预措施
No Antibiotics arm
Participants will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures
干预措施: Placebo intravenous injection (Other)
Intravenous prophylactic antibiotic arm
Participants will have an intravenous prophylactic antibiotics given at the induction of anaesthesia and their wounds closed with non-coated sutures
干预措施: Intravenous Cefuroxime (Drug)
Antimicrobial-coated suture arm
Participants will have an intravenous placebo injection given at the induction of anaesthesia and their wounds closed with antimicrobial-coated sutures
干预措施: Antimicrobial-coated sutures (Device)
结局指标
主要结局
Surgical site infection
时间窗: 30 days post operative period
次要结局
未报告次要终点
研究者
Olawumi Olajide
Senior Registrar
Obafemi Awolowo University Teaching Hospital