Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
NCT ID: NCT04678154
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1200 participants
INTERVENTIONAL
2021-05-07
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intramedullary Calcium Sulfate Antibiotic Depot
NCT05766670
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
NCT04597008
Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)
NCT02227446
Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens
NCT03560232
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
NCT03705962
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
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
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)
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
Major Extremity Trauma Research Consortium
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Micahel J Bosse, MD
Role: PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Rachel Seymour, PhD
Role: PRINCIPAL_INVESTIGATOR
Atrium Health Musculoskeletal Institute Research
Renan C Castillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Anthony R Carlini, MS
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Redwood City, California, United States
_University of California, San Francisco
San Francisco, California, United States
University of California at San Francisco
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
St Mary's University/Tenent Health
West Palm Beach, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, United States
Indiana University/Eskenazi Health
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
LSU Health Sciences
New Orleans, Louisiana, United States
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, United States
Walter Reed Military Medical Center
Bethesda, Maryland, United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
METROHealth
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Temple University
Philadelphia, Pennsylvania, United States
Brown University/Rhode Island Hospital
Providence, Rhode Island, United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center - Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax MEdical Campus
Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christine Churchill
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W81XWH-19-2-0062
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.