Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy.

Antibiotic Prophylaxis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818766
• Other study ID #: 2007p002164
• Status: Completed
• Phase: N/A
• First received: January 7, 2009
• Last updated: May 16, 2012
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antibiotic Prophylaxis

Intervention

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
Subjects will receive IV placebo for 48 hours post-operatively, or until all chest tubes are removed -- whichever comes first.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis.		30 days	No
Secondary	Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality.		30 days	No