Preventing Infections in Orthopaedic Patients

Open Fracture Clinical Trial

Official title:

Antibiotic Prophylaxis for Type II and III Open Fractures: a Retrospective Chart Review

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02948387
• Other study ID #: TEF-IT-40A
• Status: Not yet recruiting
• Phase: N/A
• First received: October 14, 2016
• Last updated: October 26, 2016
• Start date: November 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2016
• Source: Triple O Research Institute PA
• Contact: Paul Glickman
• Phone: 561-855-7871
• Email: pglickmn[@]tripleoresearch.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Open Fracture

Locations

Country	Name	City	State
United States	Triple O Research Institute PA	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Olayemi Osiyemi MD	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of fracture site infections	number of infections	30 days	No
Secondary	Incidence of acute renal injury	number of patients with worsening renal function from baseline	30 days	No
Secondary	type of bacteria infection	name of bacteria infection	30 days	No
Secondary	resistance trend in patients with infections	describe the number of MDRO infections	30 days	No
Secondary	number of secondary infections at site other than fracture sites	describe the number infections at secondary sites	30 days	No