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

May 20, 2010 updated by: St. Luke's Hospital, Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital and Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital, Pennsylvania

Investigators

  • Principal Investigator: Nathaniel McQuay, MD, St. Luke's Hospital and Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (ESTIMATE)

May 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2010

Last Update Submitted That Met QC Criteria

May 20, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLHN 2005-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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