Extended Antibiotic Prophylaxis for the Prevention of Infectious Complications Associated With Tube Thoracostomy in Patients Undergoing Elective General Thoracic Surgery: A Double-Blind, Placebo-Controlled, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced At Least One Postoperative Infectious Complication
研究概览
简要总结
The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases infectious complications when compared to pre-operative antibiotics alone, in patients undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).
详细描述
There is currently no evidence-based standard for the extended use of prophylactic antibiotics in patients receiving thoracic surgery that results in the placement of a tube thoracostomy (chest tube). The rationale for this prophylaxis is that antibiotics directed at typical skin flora may reduce the rate of infectious complications, such as surgical site infection and empyema.
Currently, clinicians' approach to post-operative antibiotic prophylaxis in patients undergoing tube thoracostomy associated with thoracic and cardio-thoracic surgery varies widely. While reducing the infectious complications of thoracic surgery is an important goal, it is also important to reduce the use of unnecessary antibiotics. As there is equipoise on the benefit of extended antibiotic prophylaxis for tube thoracostomy, our study will examine two prevailing clinical practices and attempt to determine if one leads to better patient outcomes.
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
- •Adults aged 18 years or older undergoing elective thoracic surgery at Brigham & Women's Hospital. The majority of these patients will be undergoing lung resection for either the evaluation of a lung mass, or for the removal of a known malignancy. Some participants may be undergoing biopsy or removal of a mediastinal mass.
- •Undergoing thoracic surgery procedure expected to require tube thoracostomy.
- •Ability to give informed consent
排除标准
- •Patients undergoing the following complex thoracic surgical procedures:
- •Pneumonectomy
- •Decortication
- •Chemical pleurodesis
- •Pleurectomy
- •Lung volume reduction
- •Esophagectomy
- •Patients with the following conditions:
- •Prior diagnosis of empyema or lung abscess.
- •Cystic fibrosis
- •Known or suspected pneumonia pre-operatively.
- •Known hypersensitivity to beta-lactam antibiotics and vancomycin
- •Current or recent antibiotic use within one week of surgery.
- •Anticipated requirement for postoperative antibiotic in addition to 48 hours of cefazolin or vancomycin.
- •Renal insufficiency with estimated creatinine clearance <60 ml/minute.
研究组 & 干预措施
Antibiotic
Participants received intravenous (IV) cefazolin or vancomycin (for participants allergic to cephalosporin) immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.
干预措施: cefazolin or vancomycin (Drug)
Placebo
Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced At Least One Postoperative Infectious Complication
时间窗: Up to 28 days after surgery
Infectious complications include: surgical site infection, empyema, pneumonia, and the occurrence of Clostridium difficile colitis within 28 days of surgery. Participants are only counted once regardless of how many different infectious complications they had.
Number of Participants Who Experienced Surgical Site Infection
时间窗: Up to 28 days after surgery
Surgical Site Infection: 1. Superficial surgical site infection - involves only skin or subcutaneous tissue around incision and has at least one of the following criteria: * purulent drainage * organisms isolated from aseptically obtained culture * pain or tenderness, localized swelling, redness or heat and the incision deliberately opened by a surgeon * diagnosis of a superficial wound infection by a surgeon 2. Deep surgical site infection - involves deep soft tissues e.g. fascia or muscle and has at least one of the following: * purulent drainage from the incision but not from the organ/space of the surgical site * deep incision spontaneously dehisces or deliberately opened by surgeon when patient has at least one of following signs or symptoms - fever (\>38°C), localized pain or tenderness. * an abscess or evidence of infection involving incision is found on direct examination, histopathologic or radiographic examination * diagnosis of a deep wound infection
Number of Participants Who Experienced Pneumonia
时间窗: Up to 28 days after surgery
Pneumonia: A new infiltrate on chest x-ray associated with at least three of the following: * fever (\>38°C) * purulent sputum * leukopenia (white blood cell \[WBC\] count of \<4000/µL) or leukocytosis (WBC count of \>11000/µL) * sputum culture with pathogenic bacteria * increased oxygen requirements
Number of Participants Who Experienced Empyema
时间窗: Up to 28 days after surgery
Empyema: Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (\>38°C).
Number of Participants Who Experienced Clostridium (C) Difficile Colitis
时间窗: Up to 28 days after surgery
C. Difficile Colitis: Positive for C difficile toxin assay results and any 1 of the following: * new diarrhea * ileus or toxic megacolon * leukopenia (WBC count of \<4000/µL) or leukocytosis (WBC count of \>11000/µL) * findings from sigmoidoscopy, colonoscopy, or histopathologic examination consistent with C difficile infection
次要结局
- Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery(Up to 28 days after surgery)
- Number of Participants Who Needed Reoperation(Up to 28 days after surgery)
- Length of Hospital Stay(From day of surgery to discharge (up to 35 days))
- Time to Removal of Chest Tubes(From day of surgery to removal of chest tubes (up to 33 days))
- Number of Participants With Allergic Reactions(Up to 28 days after surgery)
- All-Cause Mortality(Up to 28 days after surgery)
研究者
David A. Oxman, MD
Co-Investigator
Brigham and Women's Hospital