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Completed

NCT Number: NCT01127880

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

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.

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Key information

Conditions

Hemopneumothorax Hemorrhage Hemothorax Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ancef or Clindamycin

Drug

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

Placebo

Drug

.9% Normal Saline as a placebo

Primary outcomes

  1. 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

  1. Incidence of Pneumonia and/or development of resistant microorganisms

    Time frame: 30 days

    Secondary objectives include:

    Incidence of pneumonia Incidence of development of resistant microorganisms

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital, Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 21, 2010
Registry last updated
May 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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