Expired Study
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Boston, Massachusetts 02115


Purpose:

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).


Study summary:

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.


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 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.


NCT ID:

NCT00818766


Primary Contact:

Principal Investigator
Lindsey Baden, MD
Brigham and Women's Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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