Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Antibiotic||
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.
|Placebo Comparator: Placebo||
Subjects will receive IV placebo for 48 hours post-operatively, or until all chest tubes are removed -- whichever comes first.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818766
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lindsey Baden, MD||Brigham and Women's Hospital|