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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01127880

Enrollment

Registered

2010-05-21

Start date

2005-07-31

Completion date

2009-12-31

Last updated

2010-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemopneumothorax, Pneumothorax

Keywords

Traumatic Hemopneumothorax, Thoracotomy, Antibiotics

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.

Interventions

DRUGAncef or Clindamycin

1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic

DRUGPlacebo

.9% Normal Saline as a placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026