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

Sponsor:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00818766

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).

Condition	Intervention
Surgical Infections	Drug: cefazolin or vancomycin Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Surgery

Drug Information available for: Cefazolin Cefazolin sodium Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Antibiotic: Active Comparator	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: Placebo Comparator	Drug: Placebo Subjects will receive IV placebo for 48 hours post-operatively, or until all chest tubes are removed -- whichever comes first.

Arms

Assigned Interventions

Antibiotic: Active Comparator

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: Placebo Comparator

Drug: Placebo

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818766

Contacts

Contact: David A Oxman, MD	617-525-6782	doxman@partners.org
Contact: Lindsey Baden, MD	617-732-6801	lbaden@partners.org

Locations

United States, Massachusetts
Brigham & Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: David Oxman, MD 617-525-6782 doxman@partners.org

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Lindsey Baden, MD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( Lindsey Baden, MD )
Study ID Numbers:	2007p002164
Study First Received:	January 7, 2009
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00818766 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Thoracic Surgery
Antibiotic Prophylaxis
Chest Tube

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Cefazolin
Therapeutic Uses

Vancomycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010