Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT

Last updated: August 8, 2024
Sponsor: Major Extremity Trauma Research Consortium
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Standard of care

Vancomycin and Tobramycin

Clinical Study ID

NCT04678154
W81XWH-19-2-0062
  • Ages 18-64
  • All Genders

Study Summary

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Injury meeting at least one of the following criteria:
  • Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon)requiring a second procedure for final debridement and definitive coverage /closure following the index stabilization

  • Gustilo type IIIB ankle fractures (OTA 44)

  • Gustilo type IIIB calcaneus fractures (OTA 82)

  • Gustilo type IIIB talus fractures (OTA 81)

  • Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flapcoverage

  1. Ages 18 - 64 years inclusive

  2. Patients may have risk factors for infection including diabetes, immunosuppressionfrom steroids or other medications, HIV, or other infections.

  3. Patients may have a traumatic brain injury.

  4. Patients may have other fractures including spine, upper extremity fractures,contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or footinjuries.

  5. Patients may be treated initially at an outside institution prior to transfer to thestudy institution, as long as the definitive wound closure or coverage was notperformed prior to entrance into the study.

  6. Patients with bilateral injuries that meet inclusion criteria may be included, butonly the limb rated as "more severe" by the treating surgeon will be enrolled in thestudy.

  7. Patients may have co-existing non-tibial or hindfoot infection, with or withoutantibiotic treatment.

  8. Patients may be definitively stabilized using any method (nail, plate, ex fix orcast).

  9. Patients may have a fasciotomy.

Exclusion

Exclusion Criteria:

  1. Patient in current therapy for a wound, implant or fracture site infection relatedto the study site.

  2. Patient likely to have difficulty maintaining follow-up, including:

  • Diagnosis of a severe psychiatric condition

  • Intellectually challenged without adequate family support

  • Resides outside of the hospital's catchment area

  • Planning to follow-up at another medical center

  • Being a prisoner

  • Not having a means of contact (address, cell phone, home phone, e-mail)

Study Design

Total Participants: 1200
Treatment Group(s): 2
Primary Treatment: Standard of care
Phase: 3
Study Start date:
May 07, 2021
Estimated Completion Date:
March 30, 2025

Study Description

Specific Aim 1: To compare the surgical site infection (SSI) rates of the current severe open fracture antibiotic strategy to a revised SEXTANT treatment strategy designed to address the modern wound bioburden at the time of wound closure or coverage.

Specific Aim 2: To compare the terminal bioburden of the wounds at the time of definitive closure or coverage as sampled by standard tissue microbiology.

Specific Aim 3: To compare rates of antibiotic-related serious adverse events (SAEs) of the two treatment groups.

Exploratory Aim 4: To pilot the use of available and emerging rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.

Connect with a study center

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

  • University of California at San Francisco

    San Francisco, California 94110
    United States

    Active - Recruiting

  • _University of California, San Francisco

    San Francisco, California 94110
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • St Mary's University/Tenent Health

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Emory University School of Medicine

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Indiana University School of Medicine - Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University/Eskenazi Health

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Active - Recruiting

  • LSU Health Sciences

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • University of Maryland , MD Department of Orthopaedics

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Walter Reed Military Medical Center

    Bethesda, Maryland 20889
    United States

    Active - Recruiting

  • Harvard/Mass General/Brigham Hospitals

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Hennepin County Medical Center / Minneapolis

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Dartmouth Hitchcock

    Lebanon, New Hampshire 03766
    United States

    Active - Recruiting

  • Jamaica Hospital Medical Center

    Jamaica, New York 11418
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • METROHealth

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43201
    United States

    Active - Recruiting

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Brown University/Rhode Island Hospital

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Rhode Island Hospital/Brown University

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • University of Texas Health Science Center - Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Tech University Health Science Center

    Lubbock, Texas 79430
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Inova Fairfax MEdical Campus

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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