Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
1 other identifier
interventional
1,200
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 21, 2020
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
May 13, 2025
May 1, 2025
5.4 years
December 11, 2020
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Deep surgical site infection
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 Outcomes (2)
Deep surgical site infection
365 days from injury
Fracture revision rates
365 days from injury
Study Arms (2)
Control
ACTIVE COMPARATORParticipants 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.
Treatment
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- Ages 18 - 64 years inclusive
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
- 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.
- Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
- Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
- Patients may have a fasciotomy.
You may not qualify if:
- Patient in current therapy for a wound, implant or fracture site infection related to the study site.
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Stanford University
Redwood City, California, 94063, United States
_University of California, San Francisco
San Francisco, California, 94110, United States
University of California at San Francisco
San Francisco, California, 94110, 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
Emory University School of Medicine
Atlanta, Georgia, 30303, 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 , MD Department of Orthopaedics
Baltimore, Maryland, 21201, United States
Walter Reed Military Medical Center
Bethesda, Maryland, 20889, United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, 02115, United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Atrium Health Carolinas Medical Center
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
Temple University
Philadelphia, Pennsylvania, 19140, United States
Brown University/Rhode Island Hospital
Providence, Rhode Island, 02905, United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, 02905, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Health Science Center - Houston
Houston, Texas, 77030, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Micahel J Bosse, MD
Carolinas Medical Center
- PRINCIPAL INVESTIGATOR
Rachel Seymour, PhD
Atrium Health Musculoskeletal Institute Research
- PRINCIPAL INVESTIGATOR
Renan C Castillo, PhD
Johns Hopkins Bloomberg School of Public Health
- PRINCIPAL INVESTIGATOR
Anthony R Carlini, MS
Johns Hopkins Bloomberg School of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2020
First Posted
December 21, 2020
Study Start
May 7, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share