Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

NCT02027532 | Terminated

• 1 other identifier: 09-060
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection; Closed Fractures

Outcome Measures

Primary Outcomes (1)

• incidence of infection

  one year

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

intravenous, weight-based dose (1gm\<80kg, 2gm\>80kg), perioperatively

Drug: Cefazolin

Vancomycin

ACTIVE COMPARATOR

intravenous, weight-based dose (1gm\<80kg, 2gm\>80kg), perioperatively

Drug: Vancomycin

Interventions

Cefazolin DRUG

Cefazolin

Vancomycin DRUG

Vancomycin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Infections; Fractures, Closed

Interventions

Cefazolin; Vancomycin

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter J Nowotarski, M.D.

  UTCOM Chattanooga/Erlanger Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 6, 2014
• Study Start: October 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2017
• Last Updated: July 11, 2018

Record last verified: 2017-05

Locations

US (1)