Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

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.


Study is Available At:


Original ID:

2007p002164


NCT ID:

NCT00818766


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

251


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:March 2008
Completion Date:April 2011
Completion Type:Actual
Primary Completion Date:April 2011
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 16, 2012
First Received Date:January 7, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality.
Time Frame:30 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis.
Time Frame:30 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:cefazolin or vancomycin
Description: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.
Arm Name:Antibiotic
Other Name:Cefazolin (Ancef)
Intervention Type:Drug
Name:Placebo
Description:Subjects will receive IV placebo for 48 hours post-operatively, or until all chest tubes are removed -- whichever comes first.
Arm Name:Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:Antibiotic
Study Arm Type:Placebo Comparator
Arm Name:Placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.