Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

• Sponsor: University of Tennessee (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02027532
• Collaborator: (none)
• Enrollment: 430
• Location: 1
• Arms: 2
• Duration (Months): 98
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection; Closed Fractures	Drug: Cefazolin; Drug: Vancomycin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 430 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. incidence of infection [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Tennessee
• ClinicalTrials.gov Identifier: NCT02027532
• Other Study ID Numbers: 09-060; NCT01029457
• First Posted: Jan 6, 2014
• Last Update Posted: Jul 11, 2018
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Infections; Communicable Diseases; Fractures, Bone; Fractures, Closed; Vancomycin; Cefazolin

Study Results

No Results Posted as of Jul 11, 2018