ACTIVE_NOT_RECRUITING

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

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Conditions

Post Operative Surgical Site InfectionSurgical site infection risk preventionBacterial species type and antibacterial sensitivities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

Official Title

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial

Quick Facts

Study Start:2021-05-11
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04597008

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection:
  2. 1. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.
  3. 2. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
  4. 3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds.
  5. 2. Patients ages 18 through 80 years.
  1. 1. Study injury is already infected at time of study enrollment.
  2. 2. Definitive fixation of the study injury prior to enrollment in the study.
  3. 3. The patient never receives study fixation.
  4. 4. Massive myonecrosis from ipsilateral leg compartment syndrome.
  5. 5. Currently pregnant.
  6. 6. Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information).
  7. 7. Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
  8. 8. Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.

Contacts and Locations

Principal Investigator

Robert V O'Toole, MD, MS
PRINCIPAL_INVESTIGATOR
University of Maryland, Department of Orthopaedic Trauma
Renan C Castillo, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Anthony R Carlini, MS
STUDY_DIRECTOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

University of Alabama Heersink School of Medicine
Birmingham, Alabama, 35205
United States
Keck School of Medicine of USC
Los Angeles, California, 90033
United States
Stanford University
Redwood City, California, 94063
United States
_University of California, San Francisco
San Francisco, California, 94110
United States
Cedars Sinai
West Hollywood, California, 90069
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
St Mary's University/Tenent Health
West Palm Beach, Florida, 33407
United States
Loyola University Chicago
Chicago, Illinois, 60153
United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, 46202
United States
Indiana University/Eskenazi Health
Indianapolis, Indiana, 46202
United States
University of Kentucky
Lexington, Kentucky, 40506
United States
LSU Health Sciences
New Orleans, Louisiana, 70112
United States
University of Maryland Shock Trauma Center
Baltimore, Maryland, 21201
United States
University of Maryland Shock Trauma/Capitol Regions
Baltimore, Maryland, 21201
United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, 02115
United States
Core Well Health
Grand Rapids, Michigan, 49503
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766
United States
New York Presbyterian/Hospital for Special Surgery
New York City, New York, 10021
United States
Jamaica Hospital Medical Center
Queens, New York, 11418
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute
Charlotte, North Carolina, 28203
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
METROHealth
Cleveland, Ohio, 44109
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43201
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73104
United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033
United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19106
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, 02905
United States
Medical University of South Carolina -
Charleston, South Carolina, 29425
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246
United States
UTHealth/McGovern Medical School
Houston, Texas, 77030
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
University of Utah
Salt Lake City, Utah, 84108
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Inova Fairfax MEdical Campus
Falls Church, Virginia, 22042
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

  • Robert V O'Toole, MD, MS, PRINCIPAL_INVESTIGATOR, University of Maryland, Department of Orthopaedic Trauma
  • Renan C Castillo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health
  • Anthony R Carlini, MS, STUDY_DIRECTOR, Johns Hopkins Bloomberg School of Public Health

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 Registration Dates

Study Start Date2021-05-11
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2021-05-11
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Surgical site infection risk prevention
  • Bacterial species type and antibacterial sensitivities

Additional Relevant MeSH Terms

  • Post Operative Surgical Site Infection