A Randomized Controlled Study Assessing Prolonged Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration in Elective Clean and Clean-contaminated Surgeries for Prevention of Surgical Site Infections
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of Surgical site infection
研究概览
简要总结
The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics
详细描述
Patients undergoing above 18 years of age, giving consent and undergoing open or laparoscopic elective, CDC class I & II surgeries will be recruited. Cases will be randomised into two cohorts viz: parenteral antibiotic (Group A) vs single-time intra-operative intra-dermal antibiotic administration group (Group B). In operation theatre, after induction of anaesthesia, Group A will receive parenteral ceftriaxone (15-20mg/kg) whereas Group B will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline). Post-operatively, incision site will be covered with occlusive dressing. First check-dressing will be done after 48 hours as per the existing institutional practices. After that surgical site will be inspected daily for wound infection. Patients with healthy wound will be discharged at the discretion of the treating surgeon and will be asked to follow up in General Surgery OPD weekly for one month. Cases who developed an SSI will have samples collected from the afflicted area for bacterial culture and antibiotic susceptibility testing. On development of SSI, the treating clinical team will commence antibiotic therapy as per their protocols.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients above the age of 18 years
- •Patients undergoing open and laparoscopic elective, CDC class I & II surgeries
排除标准
- •Patients exhibiting hypersensitivity reaction to ceftriaxone
- •Patients who are immunocompromised (retroviral disease and corticosteroid use)
- •Patients not consenting to be a part of this study
- •Pregnancy
- •Febrile illness or leucocytosis at the time of surgery
- •Planned for staged/multiple interventions during the hospital stay (endoscopies, image-guided biopsies etc)
- •Patients with a possible septic focus distant from the surgical site such as diabetic foot ulcers.
研究组 & 干预措施
Local
Participants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline)
干预措施: Ceftriaxone Sodium (Drug)
Parenteral
Participants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol
干预措施: Ceftriaxone Sodium (Drug)
结局指标
主要结局
Incidence of Surgical site infection
时间窗: 1 month
Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: 1. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless the incision is culture-negative. 4. Diagnosis of superficial incisional SSI by the surgeon or attending physician
Organism isolated from wound
时间窗: 1 month
Microorganism grown on wound swab - Nominal data
次要结局
- Total duration of hospital stay(1 month)
研究者
Parth Bhavesh Gada
Junior Resident
The Grant Medical College & Sir J.J. Group of Hospitals