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

Phase 2

Completed

• Conditions: Pneumothorax; Hemopneumothorax
• Interventions: Drug: Ancef or Clindamycin; Drug: Placebo

• Registration Number: NCT01127880
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

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.

Study Timeline

• Study Start: 2005-07
• Status Verified: 2009-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-20
• Last Update Submitted: 2010-05-20
• Study First Posted: 2010-05-21
• Last Update Posted: 2010-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ancef 1 gm or Clindamycin 300 mg	Ancef or Clindamycin	Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
Placebo	Placebo	Group B will receive .9% Normal Saline as a placebo.

Primary Outcome Measures

Name	Time	Method
efficacy of prophylactic antibiotics in reduction of empyema	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 Outcome Measures

Name	Time	Method
Incidence of Pneumonia and/or development of resistant microorganisms	30 days	Secondary objectives include: Incidence of pneumonia Incidence of development of resistant microorganisms

Trial Locations

Locations (1)

St. Luke's Hospital and Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States