Clinical trial NCT00818766: Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Prophylaxis
Keywords: Thoracic Surgery
Antibiotic Prophylaxis
Chest Tube
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-01-08
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Experienced At Least One Postoperative Infectious Complication
timeFrame: Up to 28 days after surgery
measure: Number of Participants Who Experienced Surgical Site Infection
timeFrame: Up to 28 days after surgery
measure: Number of Participants Who Experienced Pneumonia
timeFrame: Up to 28 days after surgery
measure: Number of Participants Who Experienced Empyema
timeFrame: Up to 28 days after surgery
measure: Number of Participants Who Experienced Clostridium (C) Difficile Colitis
timeFrame: Up to 28 days after surgery
Secondary outcomes:
measure: Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery
timeFrame: Up to 28 days after surgery
measure: Number of Participants Who Needed Reoperation
timeFrame: Up to 28 days after surgery
measure: Length of Hospital Stay
timeFrame: From day of surgery to discharge (up to 35 days)
measure: Time to Removal of Chest Tubes
timeFrame: From day of surgery to removal of chest tubes (up to 33 days)
measure: Number of Participants With Allergic Reactions
timeFrame: Up to 28 days after surgery
measure: All-Cause Mortality
timeFrame: Up to 28 days after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lindsey Baden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.