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Preventing Infections in Orthopaedic Patients

NCT ID: NCT02948387

Last Updated: 2016-10-28

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-02-28

Brief Summary

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Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.

Detailed Description

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1. Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
2. Identify the incidence of acute kidney injury.
3. Identify the type and number of associated infections
4. Identify the antibiotic resistance profile noted
5. Identify any secondary infections at sites other than the fracture site

Conditions

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Open Fracture

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or Female \>= 18 years old
* Patients are diagnosed with a Type II or III open fracture

Exclusion Criteria

* Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
* pregnancy
* did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
* receiving ongoing inpatient care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Olayemi Osiyemi MD

OTHER

Sponsor Role lead

Responsible Party

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Olayemi Osiyemi MD

President

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Olayemi Osiyemi, MD

Role: PRINCIPAL_INVESTIGATOR

Triple O Research Institute PA

Locations

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Triple O Research Institute PA

West Palm Beach, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Paul Glickman

Role: CONTACT

Phone: 561-855-7871

Email: [email protected]

Olayemi Osiyemi, MD

Role: CONTACT

Phone: 561-855-7871

Email: [email protected]

Other Identifiers

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TEF-IT-40A

Identifier Type: -

Identifier Source: org_study_id