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Recruiting Phase 3 Interventional

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2

ClinicalTrials.gov ID: NCT04678154

Public ClinicalTrials.gov record NCT04678154. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:41 AM EDT

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Official title

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 - A Continuation of the Multicenter Randomized Control Trial SEXTANT 1

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers. The patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of final wound closure/coverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol. Up until the time of definitive wound closure/coverage, all patients will be treated per the usual regimen of the surgeon / center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includes the administration of systemic antibiotics as close to the time of injury as possible. In the definitive wound closure/coverage procedure post-operative period, participants in the intervention arm will receive 72 hours of systemic antibiotic therapy targeted at the modern wound bioburden, and patients in the usual care arm will receive post-operative care per the usual practice of their surgeon. All other activities related to follow-up and related treatments will proceed per the usual practice of the surgeon.

Study identification

NCT ID
NCT04678154
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
600 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 6, 2021
Primary completion
Sep 29, 2028
Completion
Mar 30, 2029
Last update posted
Jul 21, 2026

2021 – 2029

United States locations

U.S. sites
31
U.S. states
21
U.S. cities
28
Facility City State ZIP Site status
Stanford University Redwood City California 94063 Recruiting
_University of California, San Francisco San Francisco California 94110 Recruiting
University of California at San Francisco San Francisco California 94110 Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado 80045 Recruiting
St Mary's University/Tenent Health West Palm Beach Florida 33407 Recruiting
Emory University School of Medicine Atlanta Georgia 30303 Recruiting
Indiana University School of Medicine - Methodist Hospital Indianapolis Indiana 46202 Recruiting
Indiana University/Eskenazi Health Indianapolis Indiana 46202 Recruiting
University of Kentucky Lexington Kentucky 40506 Recruiting
LSU Health Sciences New Orleans Louisiana 70112 Recruiting
University of Maryland , MD Department of Orthopaedics Baltimore Maryland 21201 Recruiting
Walter Reed Military Medical Center Bethesda Maryland 20889 Recruiting
Harvard/Mass General/Brigham Hospitals Boston Massachusetts 02115 Recruiting
Hennepin County Medical Center / Minneapolis Minneapolis Minnesota 55415 Recruiting
University of Mississippi Medical Center Jackson Mississippi 39216 Recruiting
Dartmouth Hitchcock Lebanon New Hampshire 03766 Recruiting
Jamaica Hospital Medical Center Jamaica New York 11418 Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514 Recruiting
Atrium Health Carolinas Medical Center Charlotte North Carolina 28203 Recruiting
Atrium Health Wake Forest Baptist Winston-Salem North Carolina 27157 Recruiting
METROHealth Cleveland Ohio 44109 Recruiting
Ohio State University Wexner Medical Center Columbus Ohio 43201 Recruiting
University of Oklahoma College of Medicine Oklahoma City Oklahoma 73104 Recruiting
Temple University Philadelphia Pennsylvania 19140 Recruiting
Brown University/Rhode Island Hospital Providence Rhode Island 02905 Recruiting
Rhode Island Hospital/Brown University Providence Rhode Island 02905 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37232 Recruiting
University of Texas Health Science Center - Houston Houston Texas 77030 Recruiting
University of Virginia Charlottesville Virginia 22903 Recruiting
Inova Fairfax MEdical Campus Falls Church Virginia 22042 Recruiting
Virginia Commonwealth University Medical Center Richmond Virginia 23298 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04678154, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 21, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04678154 live on ClinicalTrials.gov.

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