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

June 9, 2026 updated by: Major Extremity Trauma Research Consortium

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1036

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland R Adams Cowley Shock Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vancomycin Antibotic Powder

Participants in the treatment group will receive the study intervention of a maximum dose of 1000mg of Vancomycin antibiotic powder in their wound bed, which is placed right before wound closure. Vancomycin antibiotic powder may be combined with normal saline as per clinical practice at the participating institution.

In addition, participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.
Drug: Vancomycin antibiotic powder
At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.
No Intervention: Standard of Care
Participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Participants in this group will not receive local Vancomycin antibiotic powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Clinically Significant Deep Surgical Site Infection (SSI)
Time Frame: 26 weeks

The main outcome will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. The CDC criteria is currently 3 months for surgical site infection. To help capture more infections the study investigators have moved the time frame back to 6 months.

Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS).

The study investigators will define deep infections as those that require operative treatment, and superficial infections as those that are treated without operative intervention.
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathogen Type
Time Frame: 26 weeks
This secondary outcome represents the type of bacteria or fungus isolated from the fracture site at the time of surgery for infection during the follow up period. Cultures were obtained using routine clinical sterile technique in the operating room and processed according to standard laboratory practices at each participating site. An infectious disease physician blinded to treatment arm reviewed and categorized all culture results. Pathogens were classified into five groups: gram-positive cocci, gram-positive rods, gram-negative rods, anaerobes, and fungi. The frequency of each pathogen type recovered was compared between patients who received topical vancomycin powder during surgery and those who did not.
26 weeks
Bacterial Susceptibility and Antimicrobial Resistance
Time Frame: 26 weeks
This secondary outcome characterizes the susceptibility of recovered pathogens to commonly used antibiotics collected at the time of surgery for infection during follow up. Antimicrobial susceptibility testing was performed by hospital laboratories using standard methods at each participating site. The pattern of susceptibility and resistance to various antimicrobial agents was compared between the two treatment groups to assess whether exposure to topical vancomycin powder was associated with differences in antibiotic resistance profiles, including the emergence of resistant organisms or other hard-to-treat pathogens.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Major Extremity Trauma Research Consortium

Investigators

  • Principal Investigator: Robert O'Toole, MD, University of Maryland R Adams Cowley Shock Trauma Center
  • Study Director: Anthony Carlini, MS, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Renan Castillo, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimated)

August 28, 2014

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-10-2-0134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Operative Surgical Site Infection

Clinical Trials on Vancomycin antibiotic powder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe