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
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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