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

NCT ID: NCT00818766

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-04-30

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 thoracic surgery requiring tube thoracostomy (chest tube).

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 benefit 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.

Conditions

Antibiotic Prophylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Antibiotic

Participants received intravenous (IV) cefazolin or vancomycin (for participants allergic to cephalosporin) immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.

Group Type: ACTIVE_COMPARATOR

cefazolin or vancomycin

Intervention Type: DRUG

Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were penicillin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.

Placebo

Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.

Interventions

cefazolin or vancomycin

Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were penicillin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.

Intervention Type: DRUG

Placebo

Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.

Intervention Type: DRUG

Other Intervention Names

Cefazolin (Ancef); Vancomycin (Vancocin)

Eligibility 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 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David A. Oxman, MD

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsey Baden, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Oxman DA, Issa NC, Marty FM, Patel A, Panizales CZ, Johnson NN, Licona JH, McKenna SS, Frendl G, Mentzer SJ, Jaklitsch MT, Bueno R, Colson Y, Swanson SJ, Sugarbaker DJ, Baden LR. Postoperative antibacterial prophylaxis for the prevention of infectious complications associated with tube thoracostomy in patients undergoing elective general thoracic surgery: a double-blind, placebo-controlled, randomized trial. JAMA Surg. 2013 May;148(5):440-6. doi: 10.1001/jamasurg.2013.1372.

Reference Type: DERIVED

PMID: 23325435 (View on PubMed)

Other Identifiers

2007p002164

Identifier Type: -

Identifier Source: org_study_id