Actively Recruiting
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial
Led by Major Extremity Trauma Research Consortium · Updated on 2026-05-26
1200
Participants Needed
31
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Major Extremity Trauma Research Consortium
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center randomized controlled trial to compare the current standard treatment with a new SEXTANT antibiotic protocol in patients who have severe open fractures of the tibia and certain ankle and hindfoot fractures. The study aims to evaluate differences in surgical site infection rates, wound bacterial presence at closure, and antibiotic-related serious side effects between these treatment approaches. Additionally, a pilot study will explore rapid PCR testing methods to identify wound pathogens in a subset of patients. Participants in the control group will receive the usual care specific to their institution for preventing and treating infections. Those in the SEXTANT group will have Vancomycin (1000 mg) and Tobramycin (1200 mg) applied directly to the wound, fracture site, and any exposed hardware just before the wound is closed or covered. They will also receive at least 72 hours of systemic antibiotic treatment targeting the modern bacteria found in wounds. During the study, participants will be monitored for deep surgical site infections up to 182 days following injury, with further assessments extending to a year. Researchers will collect tissue samples to analyze wound bacteria and track any serious antibiotic-related adverse events. Follow-up will include evaluations of fracture revision rates and safety monitoring throughout the study period, which spans multiple months after injury.
CONDITIONS
Brief Title
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Injury meeting at least one of the following: Gustilo type III tibia fracture requiring second procedure for final debridement and closure; Gustilo type IIIB ankle, calcaneus, or talus fractures; traumatic trans-tibial amputations requiring delayed primary closure or flap coverage
- Ages 18 to 64 years inclusive
- Patients may have risk factors for infection such as diabetes, immunosuppression, HIV, or other infections
- Patients may have a traumatic brain injury
- Patients may have other fractures including spine, upper extremity, contralateral lower extremity, pelvis, hip, femur, or foot injuries
- Patients may be initially treated at another institution if definitive closure was not done before study entry
- Bilateral injuries allowed but only the more severe limb will be enrolled
- Patients may have co-existing non-tibial or hindfoot infection with or without antibiotic treatment
- Patients may be stabilized by any method including nail, plate, external fixator, or cast
- Patients may have had a fasciotomy
You will not qualify if you...
- Currently receiving therapy for a wound, implant, or fracture site infection at the study site
- Likely to have difficulty maintaining follow-up, such as severe psychiatric condition, intellectual challenges without family support, residing outside the hospital catchment area, planning follow-up at another center, being a prisoner, or lacking contact information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - At least 72 hours after wound closure
Participants receive either the standard antibiotic care or the SEXTANT antibiotic strategy involving local antibiotics applied at wound closure plus at least 72 hours of systemic antibiotics.
1 wound closure visit plus follow-up visits during antibiotic therapy
Duration - Up to 365 days from injury
Participants are monitored for surgical site infections, fracture revisions, and antibiotic-related adverse events.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 31 locations
1
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
2
_University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
3
University of California at San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
4
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
5
St Mary's University/Tenent Health
West Palm Beach, Florida, United States, 33407
Actively Recruiting
6
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Actively Recruiting
7
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Indiana University/Eskenazi Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
10
LSU Health Sciences
New Orleans, Louisiana, United States, 70112
Actively Recruiting
11
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
Walter Reed Military Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
13
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, United States, 02115
Actively Recruiting
14
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
15
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
16
Dartmouth Hitchcock
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
17
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
Actively Recruiting
18
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
19
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
20
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
21
METROHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
22
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43201
Actively Recruiting
23
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
24
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
25
Brown University/Rhode Island Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
26
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States, 02905
Actively Recruiting
27
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
University of Texas Health Science Center - Houston
Houston, Texas, United States, 77030
Actively Recruiting
29
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
30
Inova Fairfax MEdical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
31
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
S
Suna Chung, MPH
S
Susan C Collins, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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