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 ParticipantsIdentify 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
|