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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02027532
Other study ID # 09-060
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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