Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Purpose
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.
Condition
- Post Operative Surgical Site Infection
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
Stanford University
Redwood City, California 94063
Redwood City, California 94063
_University of California, San Francisco
San Francisco, California 94110
San Francisco, California 94110
University of California at San Francisco
San Francisco, California 94110
San Francisco, California 94110
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Aurora, Colorado 80045
St Mary's University/Tenent Health
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
Emory University School of Medicine
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Indiana University/Eskenazi Health
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
University of Kentucky
Lexington, Kentucky 40506
Lexington, Kentucky 40506
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Walter Reed Military Medical Center
Bethesda, Maryland 20889
Bethesda, Maryland 20889
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Jamaica Hospital Medical Center
Jamaica, New York 11418
Jamaica, New York 11418
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Contact:
Christine Churchill
Christine Churchill
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Ohio State University Wexner Medical Center
Columbus, Ohio 43201
Columbus, Ohio 43201
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Temple University
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Brown University/Rhode Island Hospital
Providence, Rhode Island 02905
Providence, Rhode Island 02905
Rhode Island Hospital/Brown University
Providence, Rhode Island 02905
Providence, Rhode Island 02905
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
University of Texas Health Science Center - Houston
Houston, Texas 77030
Houston, Texas 77030
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
Inova Fairfax MEdical Campus
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Virginia Commonwealth University Medical Center
Richmond, Virginia 23298
Richmond, Virginia 23298
More Details
- NCT ID
- NCT04678154
- Status
- Recruiting
- Sponsor
- Major Extremity Trauma Research Consortium
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.