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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemopneumothorax, Pneumothorax

Intervention / Treatment
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* Drug: Ancef or Clindamycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Pregnancy Open fracture Immunocompromised Require antibiotics for treatment of other injuries Chest tube placement greater than 72hrs after admission

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ancef 1 gm or Clindamycin 300 mg<br>Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists | Drug: Ancef or Clindamycin<br>* 1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic<br>|
| Placebo Comparator: Placebo<br>Group B will receive .9% Normal Saline as a placebo. | Drug: Placebo<br>* .9% Normal Saline as a placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of prophylactic antibiotics in reduction of empyema | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pneumonia and/or development of resistant microorganisms | Secondary objectives include: Incidence of pneumonia Incidence of development of resistant microorganisms | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Hemopneumothorax, Thoracotomy, Antibiotics