Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hemopneumothorax Pneumothorax	Drug: Ancef or Clindamycin Drug: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study

Resource links provided by NLM:

Genetics Home Reference related topics: primary spontaneous pneumothorax

MedlinePlus related topics: Antibiotics

Drug Information available for: Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Cefazolin Cefazolin sodium Clindamycin palmitate

U.S. FDA Resources

Further study details as provided by St. Luke's Hospital, Pennsylvania:

Primary Outcome Measures:

efficacy of prophylactic antibiotics in reduction of empyema [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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:

Incidence of Pneumonia and/or development of resistant microorganisms [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary objectives include:

Incidence of pneumonia Incidence of development of resistant microorganisms

Enrollment:	50
Study Start Date:	July 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127880

Locations

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

Sponsors and Collaborators

St. Luke's Hospital, Pennsylvania

Investigators

Principal Investigator:

Nathaniel McQuay, MD

St. Luke's Hospital and Health Network

More Information

No publications provided

Responsible Party:	Nathaniel McQuay, Jr., MD, St. Luke's Hospital and Health Network
ClinicalTrials.gov Identifier:	NCT01127880 History of Changes
Other Study ID Numbers:	SLHN 2005-34
Study First Received:	May 19, 2010
Last Updated:	May 20, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Luke's Hospital, Pennsylvania:

Traumatic Hemopneumothorax
Thoracotomy
Antibiotics

Additional relevant MeSH terms:

Hemopneumothorax
Pneumothorax
Hemothorax
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes
Anti-Bacterial Agents
Cefazolin

Clindamycin
Clindamycin-2-phosphate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013