Prophylaxis Against Surgical Site Infections Using Local as Well as Systemic Antibiotic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Frequency of Surgical Site Infection
研究概览
简要总结
Surgical site infections were defined as infections that developed in the area of an operation within 30 days after surgery. They remained a common problem after surgery and could increase pain, delay wound healing, prolong hospital stay, increase treatment costs, and raise the risk of further complications. Although systemic antibiotics were routinely used before surgery to reduce this risk, it was not yet clear whether adding a local antibiotic directly into the wound provided better protection than systemic antibiotics alone.
This randomized controlled trial was planned to compare two methods of antibiotic prophylaxis in adult patients undergoing clean or clean-contaminated elective surgery at Surgical Unit I, Lahore General Hospital, Lahore. One group received the standard prophylactic systemic antibiotic cefazolin intravenously before surgery. The other group received the same systemic antibiotic together with local gentamicin applied into the surgical wound during the operation. The purpose of the study was to determine whether the combined use of local and systemic antibiotics reduced the frequency of surgical site infection more effectively than systemic antibiotic prophylaxis alone.
The study included adult patients of either gender who were able to provide informed consent and were undergoing elective procedures such as hernia repair or laparoscopic cholecystectomy. Patients with allergy to cefazolin or gentamicin, prolonged prior antibiotic use, diabetes mellitus, previous surgical site infection, immunocompromised state, coronary artery disease, chronic obstructive pulmonary disease, or chronic kidney disease were excluded.
Participants were followed during hospital stay and were then monitored for 30 days after surgery for evidence of wound infection. Surgical site infection was assessed using the Southampton wound scoring system, and any grade other than grade 0 was considered infection according to the study definition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adults aged more than 18 years
- •Individuals of either gender
- •Patients able to provide informed consent
- •Patients undergoing clean or clean-contaminated elective surgeries, such as hernia repair or laparoscopic cholecystectomy
排除标准
- •Allergy to cefazolin or gentamicin
- •Use of antibiotics for more than one week before surgery
- •Diabetes mellitus
- •Previous surgical site infection
- •Immunocompromised state
- •Coronary artery disease
- •Chronic obstructive pulmonary disease
- •Chronic kidney disease
研究组 & 干预措施
Combined Local and Systemic Antibiotic Group
Received intravenous cefazolin before surgery along with local gentamicin administered into the surgical wound intraoperatively.
干预措施: Cefazolin plus Gentamicin (Drug)
Systemic Antibiotic Alone Group
Received intravenous cefazolin before surgery without local gentamicin.
干预措施: Cefazolin (Drug)
结局指标
主要结局
Frequency of Surgical Site Infection
时间窗: Within 30 days after surgery
Surgical site infection was the primary outcome measure of the study. It was defined as any wound infection occurring at the surgical site within 30 days after surgery. Assessment was performed using the Southampton wound scoring system, and any grade other than grade 0 was considered a surgical site infection according to the study protocol.
次要结局
未报告次要终点
研究者
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital