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

Information source: Major Extremity Trauma Research Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Surgical Site Infection

Intervention: Vancomycin antibiotic powder (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Major Extremity Trauma Research Consortium

Official(s) and/or principal investigator(s):
Renan Castillo, PhD, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health
Robert O'Toole, MD, Principal Investigator, Affiliation: University of Maryland R Adams Cowley Shock Trauma Center
Lauren Allen, MA, Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health

Overall contact:
Tara Taylor, MPH, Phone: 4106146081, Email: ttaylo56@jhu.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Surgical Site Infection

Secondary outcome:

Bacterial Antibiotic Resistance Rate of Infected Participants

Identify Risk Factors for Infection

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All "high energy" tibial plateau fractures treated operatively with plate and screw

fixation.

- We define "high energy" tibial plateau fractures as patients who are either:

- Initially treated with an external fixation (with or without limited internal

fixation) and treated definitively more than 3 days later after swelling has resolved.

- Any open type I, II, or IIIA fracture, regardless of timing of definitive

treatment.

- Any tibial plateau fracture associated with ipsilateral leg compartment syndrome

fasciotomy wounds.

- All "high energy" pilon (distal tibial plafond) fractures treated operatively with

plate and screw fixation. We define "high energy" pilon fractures as patients who are either:

- Initially treated with an external fixation (with or without fibula fixation or

limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.

- Any open type I, II, or IIIA fracture, regardless of timing of definitive

treatment.

- Any tibial pilon fracture associated with ipsilateral leg compartment syndrome

fasciotomy wounds.

- Ages 18 to 80 years

- Patients may have co-existing non-tibial infection, with or without antibiotic

treatment.

- Patients may have risk factors for infection including diabetes, immunosuppression

from steroids or other medications, HIV, or other infections.

- Patients may have a head injury

- Patients may have a portion of the fixation (e. g. fibula fixation in pilon or

percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at the initial surgery before randomization.

- Patients may have other orthopedic and non-orthopaedic injuries.

- Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have

spinal cord injuries.

- Women and minorities are included

Exclusion Criteria:

- The study injury: tibial plateau, pilon, is already infected at time of study

enrollment.

- Patient speaks neither English nor Spanish.

- Patients who have already had definitive fixation prior to enrollment in the study.

- Severe problems with maintaining follow-up (e. g. patients who are homeless at the

time of injury or those how are intellectually challenged without adequate family support).

- Patients with allergies, drug administration reactions, or other sensitivities to

Vancomycin (such as a history of Redman's Syndrome).

- Pregnancy.

- The study injury is a type IIIB or IIIC open fracture.

Locations and Contacts

Tara Taylor, MPH, Phone: 4106146081, Email: ttaylo56@jhu.edu

University of Maryland R Adams Cowley Shock Trauma Center, Baltimore, Maryland 21201, United States; Not yet recruiting
Yasmin Degani, Email: ydegani@umoa.umm.edu
Robert O'Toole, MD, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: August 26, 2014

Page last updated: August 23, 2015

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