ACTIVE_NOT_RECRUITING

Tobramycin Injection to Prevent Infection in Open Fractures

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 goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance.

Official Title

Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

Quick Facts

Study Start:2022-01-10
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04964947

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. * Open fracture to arm, leg, or both
  2. * Over the age of 18
  1. * Under the age of 18
  2. * Allergy to tobramycin or any other antibiotic in the aminoglycoside family
  3. * Previously treated with a resorbable antibiotic carrier
  4. * Pregnancy

Contacts and Locations

Principal Investigator

Arun Aneja, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Arun Aneja, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2022-01-10
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-01-10
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Local antibiotic
  • Non-union
  • Aminoglycoside
  • Tobramycin
  • Open extremity fracture
  • fracture related infection

Additional Relevant MeSH Terms

  • Wound Infection
  • Fractures, Open
  • Surgical Site Infection