Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy

Mass General Brigham

Status: Completed

Conditions: Antibiotic Prophylaxis

Treatments: Drug: Placebo; Drug: cefazolin or vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00818766

2007p002164

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 2 patient groups, including a placebo group

Antibiotic

Active Comparator group

Description:

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.

Treatment:

Drug: cefazolin or vancomycin

Placebo

Placebo Comparator group

Description:

Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.

Treatment:

Drug: Placebo