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

NCT ID: NCT01127880

Last Updated: 2010-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Hemopneumothorax Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ancef 1 gm or Clindamycin 300 mg

Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists

Group Type ACTIVE_COMPARATOR

Ancef or Clindamycin

Intervention Type DRUG

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

Placebo

Group B will receive .9% Normal Saline as a placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

.9% Normal Saline as a placebo

Interventions

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Ancef or Clindamycin

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

Intervention Type DRUG

Placebo

.9% Normal Saline as a placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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St. Luke's Hospital and Health Network

Principal Investigators

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Nathaniel McQuay, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital and Health Network

Locations

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St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SLHN 2005-34

Identifier Type: -

Identifier Source: org_study_id

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