Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT02027532
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Infection
Closed Fractures
Drug: Cefazolin
Drug: Vancomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefazolin
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Drug: Cefazolin
Active Comparator: Vancomycin
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Drug: Vancomycin

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027532

Locations
United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Peter J Nowotarski, M.D. UTCOM Chattanooga/Erlanger Health System
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02027532     History of Changes
Obsolete Identifiers: NCT01029457
Other Study ID Numbers: 09-060
Study First Received: January 2, 2014
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Fractures, Bone
Fractures, Closed
Infection
Wounds and Injuries
Cefazolin
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014