NCT02227446

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,036 (actual)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Aim: 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. Primary Hypothesis: The proportion of deep surgical site infections will be lower for patients treated with local Vancomycin powder. Secondary Aim #1: Compare antibiotic sensitivities of the bacteria in the patients who develop deep surgical site infections in study patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder. Hypothesis 1: In the patients who develop infections, the antibiotic sensitivity profiles between patients treated with local Vancomycin powder will be non-inferior to those treated without local Vancomycin powder. Secondary Aim #2: Build and validate a risk prediction model for the development of deep surgical site infections in patients treated without local Vancomycin powder. (b) Explore whether the effect of local Vancomycin powder is modified by the predicted risk of infection. Hypothesis 2: Patient (e.g. medical co-morbidities) and injury (e.g open fractures) factors will be highly predictive of infection risk. Hypothesis 3: Patients with higher predictive risk will experience greater benefit from local antibiotics.

Conditions

• Post Operative Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Vancomycin antibiotic powder	At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-06-01
• Completion: 2019-11-01
• First posted: 2014-08-28
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

1 site across 1 country: United States