Actively Recruiting
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Led by Major Extremity Trauma Research Consortium · Updated on 2025-05-13
1200
Participants Needed
31
Research Sites
307 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
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.
CONDITIONS
Official 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...
- Have an injury meeting at least one of the following: Gustilo type III tibia fracture (OTA 41, 42, 43) needing second surgery for final debridement and wound closure, Gustilo type IIIB ankle fracture (OTA 44), Gustilo type IIIB calcaneus fracture (OTA 82), Gustilo type IIIB talus fracture (OTA 81), or traumatic trans-tibial amputation needing delayed primary closure or flap coverage
- Be between 18 and 64 years old
- May have risk factors for infection such as diabetes, steroid use, HIV, or other infections
- May have a traumatic brain injury
- May have other fractures including spine, upper limb, pelvis, hip, femur, or foot
- May have been initially treated at a different hospital if wound closure was not done before joining the study
- May have injuries on both limbs if one limb is rated more severe and only that limb is enrolled
- May have other infections not related to tibia or hindfoot
- May have any method of fracture stabilization (nail, plate, external fixator, cast)
- May have had a fasciotomy
You will not qualify if you...
- Currently receiving treatment for an infection at the wound, implant, or fracture site related to the study
- Likely unable to maintain follow-up due to severe psychiatric illness, intellectual disability without family support, living outside hospital area, planning follow-up elsewhere, being a prisoner, or lacking contact information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Susan C Collins, MSc
CONTACT
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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