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

May 21, 2026 updated by: Major Extremity Trauma Research Consortium

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

1200

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 Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • _University of California, San Francisco
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California at San Francisco
        • Contact:
        • Principal Investigator:
          • Saam Morshed, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
    • Florida
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University School of Medicine
        • Principal Investigator:
          • William Reisman, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine - Methodist Hospital
        • Contact:
          • Maricella Diaz
          • Phone Number: 317.963.5034
          • Email: diaz4@iu.edu
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Eskenazi Health
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University Of Kentucky
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland , MD Department of Orthopaedics
        • Principal Investigator:
          • Robert O'Toole, MD
        • Contact:
      • Bethesda, Maryland, United States, 20889
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center / Minneapolis
        • Principal Investigator:
          • Andrew Schmidt, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
    • New Hampshire
    • New York
      • Jamaica, New York, United States, 11418
        • Recruiting
        • Jamaica Hospital Medical Center
        • Principal Investigator:
          • Sanjit Konda, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health Carolinas Medical Center
        • Contact:
          • Christine Churchill
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44109
      • Columbus, Ohio, United States, 43201
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma College of Medicine
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Brown University/Rhode Island Hospital
        • Principal Investigator:
          • Roman Hayda, MD
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Rhode Island Hospital/Brown University
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • William T. Obremskey, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center - Houston
        • Contact:
        • Principal Investigator:
          • Stephen Warner, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • David Weiss, MD
        • Contact:
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Medical Campus
        • Contact:
      • Richmond, Virginia, United States, 23298

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 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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 flap coverage
  2. Ages 18 - 64 years inclusive
  3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
  4. Patients may have a traumatic brain injury.
  5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
  6. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive wound closure or coverage was not performed prior to entrance into the study.
  7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
  8. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
  9. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
  10. Patients may have a fasciotomy.

Exclusion Criteria:

  1. Patient in current therapy for a wound, implant or fracture site infection related to 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 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
Active Comparator: Control
Participants in the control 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: Standard of care
Participants in the control 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.
Experimental: Treatment
The patients in the SEXTANT cohort will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site and exposed hardware (if any) just prior to suture closure of the wound or flap. The SEXTANT cohort will then receive at least 72 hours of systemic antibiotic therapy targeted to the modern wound bioburden.
Drug: Vancomycin and Tobramycin
The patients in the SEXTANT cohort will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site and exposed hardware (if any) just prior to suture closure of the wound or flap. The SEXTANT cohort will then receive at least 72 hours of systemic antibiotic therapy targeted to the modern wound bioburden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep surgical site infection
Time Frame: 182 days from injury
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.
182 days from injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep surgical site infection
Time Frame: 365 days from injury
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.
365 days from injury
Fracture revision rates
Time Frame: 365 days from injury
Fracture revision rates for non-union, flap failure, amputation, the development of resistant bacteria discovered at revision surgery and antibiotic-related complications (C. difficile, nephrotoxicity, ototoxicity).
365 days from injury

Collaborators and Investigators

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

Sponsor

Major Extremity Trauma Research Consortium

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Micahel J Bosse, MD, Carolinas Medical Center
  • Principal Investigator: Rachel Seymour, PhD, Atrium Health Musculoskeletal Institute Research
  • Principal Investigator: Anthony R Carlini, MS, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Renan C Castillo, PhD, 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 Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-19-2-0062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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