Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

Infection Clinical Trial

Official title:

Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02027532
• Other study ID #: 09-060
• Status: Terminated
• Phase: N/A
• Start date: October 2009
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.

The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.

Other known NCT identifiers

• NCT01029457

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 430
• Est. completion date: December 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Between 18 years old and 85 years old

• Closed fracture

• Fracture treatment plan is for one operation on one day (one surgical setting)

• Likely to follow-up with surgeon until fracture is healed

• Ability to understand and agree to Informed Consent

Exclusion Criteria:

• Under 18 years old or over 85 years old

• Open fracture(s)

• Fracture requires multiple operations

• Other injuries requiring operations

• Documented allergy to Cefazolin or Vancomycin

• Previous history of Methicillin-resistant Staphylococcus aureus infection

• Previous surgery on the injured extremity within 1 year

• Use of antibiotics within 2 weeks before or after injury

• Use of antibiotics within 2 weeks before surgery

• Unlikely to follow-up until fracture is healed

• Unable to understand and agree to Informed Consent

Related Conditions & MeSH terms

• Closed Fractures
• Communicable Diseases
• Fractures, Bone
• Fractures, Closed
• Infection

Intervention

Drug:
• Cefazolin

• Vancomycin

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of infection		one year