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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David A. Oxman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00818766
First received: January 7, 2009
Last updated: May 16, 2012
Last verified: May 2012

January 7, 2009
May 16, 2012
March 2008
April 2011   (final data collection date for primary outcome measure)
Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00818766 on ClinicalTrials.gov Archive Site
Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy.
Extended Antibiotic Prophylaxis for the Prevention of Infectious Complications Associated With Tube Thoracostomy in Patients Undergoing Elective Thoracic Surgery: A Prospective, Randomized, Placebo-Controlled Trial

The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decrease infectious complications when compared to pre-operative antibiotics alone, in patients undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).

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 subject 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Antibiotic Prophylaxis
  • Drug: cefazolin or vancomycin
    Cefazolin IV every eight hours post-operatively for 48 hours, or until all chest tubes have been removed -- whichever comes first. Subjects under 80kg will receive 1 gram of cefazolin and subjects who are 80kg or more will receive 2 grams of cefazolin. Subjects who are penicillin-allergic will receive 1 gram of vancomycin every 12 hours for 48 hours, or until all chest tubes are removed -- whichever comes first.
    Other Names:
    • Cefazolin (Ancef)
    • Vancomycin (Vancocin)
  • Drug: Placebo
    Subjects will receive IV placebo for 48 hours post-operatively, or until all chest tubes are removed -- whichever comes first.
  • Active Comparator: Antibiotic
    Intervention: Drug: cefazolin or vancomycin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Oxman DA, Issa NC, Marty FM, Patel A, Panizales CZ, Johnson NN, Licona JH, McKenna SS, Frendl G, Mentzer SJ, Jaklitsch MT, Bueno R, Colson Y, Swanson SJ, Sugarbaker DJ, Baden LR. Postoperative antibacterial 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. JAMA Surg. 2013 May;148(5):440-6. doi: 10.1001/jamasurg.2013.1372.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
April 2011
April 2011   (final data collection date for primary outcome measure)

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 subjects 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00818766
2007p002164
No
David A. Oxman, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Lindsey Baden, MD Brigham and Women's Hospital
Brigham and Women's Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP