Status:
COMPLETED
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Antibiotic Prophylaxis
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00818766
Start Date
March 1 2008
End Date
April 1 2011
Last Update
April 26 2017
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115