Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy.
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgical Infections
Intervention: cefazolin or vancomycin (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
Lindsey Baden, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact:
David A Oxman, MD, Phone: 617-525-6782, Email: doxman@partners.org
Summary
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).
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis.
Secondary outcome: Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
David A Oxman, MD, Phone: 617-525-6782, Email: doxman@partners.org
Brigham & Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
David Oxman, MD, Phone: 617-525-6782, Email: doxman@partners.org
Additional Information
Starting date: March 2008
Ending date: March 2010
Last updated: July 30, 2009
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