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

Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127880
• Other study ID #: SLHN 2005-34
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 19, 2010
• Last updated: May 20, 2010
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: St. Luke's Hospital, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemopneumothorax
• Hemothorax
• Pneumothorax

Intervention

Drug:
• Ancef or Clindamycin
1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic
• Placebo
.9% Normal Saline as a placebo

Locations

Country	Name	City	State
United States	St. Luke's Hospital and Health Network	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Pneumonia and/or development of resistant microorganisms	Secondary objectives include: Incidence of pneumonia Incidence of development of resistant microorganisms	30 days