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RECRUITING

NCT04678154

PHASE3

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

Sponsor: Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2021-05-07

Completion Date

2027-03-31

Last Updated

2025-05-13

Healthy Volunteers

Conditions

Post Operative Surgical Site Infection

Interventions

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.

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.

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)

Locations (31)

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