Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)

NCT02227446 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1036

Last updated 2021-06-01

Study results available
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Summary

The Vancomycin Study is a multi-center, prospective randomized controlled trial that will compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation.

Conditions

  • Post Operative Surgical Site Infection

Interventions

DRUG

Vancomycin antibiotic powder

At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Renan Castillo, PhD · Johns Hopkins Bloomberg School of Public Health

  • Robert O'Toole, MD · University of Maryland R Adams Cowley Shock Trauma Center

  • Anthony Carlini, MS · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-06-30
Completion
2019-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02227446 on ClinicalTrials.gov