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
Summary
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
|