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Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax

Information source: St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemopneumothorax; Pneumothorax

Intervention: Ancef or Clindamycin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: St. Luke's Hospital, Pennsylvania

Official(s) and/or principal investigator(s):
Nathaniel McQuay, MD, Principal Investigator, Affiliation: St. Luke's Hospital and Health Network


The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.

Clinical Details

Official title: The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study

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

Primary outcome: efficacy of prophylactic antibiotics in reduction of empyema

Secondary outcome: Incidence of Pneumonia and/or development of resistant microorganisms

Detailed description: In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Age ≥ 16 years of age. 2. Admission to Trauma, General Surgery, and/or Surgical Critical Care services. 3. Traumatic pneumothorax, hemothorax or hemopneumothorax Exclusion Criteria: 1. Pregnancy 2. Open fracture 3. Immunocompromised 4. Require antibiotics for treatment of other injuries 5. Chest tube placement greater than 72hrs after admission

Locations and Contacts

St. Luke's Hospital and Health Network, Bethlehem, Pennsylvania 18015, United States
Additional Information

Starting date: July 2005
Last updated: May 20, 2010

Page last updated: August 23, 2015

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