The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study
Overview
- Phase
- Phase 2
- Intervention
- Ancef or Clindamycin
- Conditions
- Hemopneumothorax
- Sponsor
- St. Luke's Hospital, Pennsylvania
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- efficacy of prophylactic antibiotics in reduction of empyema
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 16 years of age.
- •Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
- •Traumatic pneumothorax, hemothorax or hemopneumothorax
Exclusion Criteria
- •Open fracture
- •Immunocompromised
- •Require antibiotics for treatment of other injuries
- •Chest tube placement greater than 72hrs after admission
Arms & Interventions
Ancef 1 gm or Clindamycin 300 mg
Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
Intervention: Ancef or Clindamycin
Placebo
Group B will receive .9% Normal Saline as a placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
efficacy of prophylactic antibiotics in reduction of empyema
Time Frame: 30 days
The primary objective 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.
Secondary Outcomes
- Incidence of Pneumonia and/or development of resistant microorganisms(30 days)