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

Recruiting now · Phase 3

Conditions studied: Post Operative Surgical Site Infection

In brief

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.

Key facts

Study ID

NCT04678154

Run by

Major Extremity Trauma Research Consortium

People needed

600

Starts

2021-05-07

Expected to finish

2029-03-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Injury meeting at least one of the following criteria:
• a. Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and/or talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure / coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and/or fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure/coverage is allowed) vi. IIIA fractures with AO/OTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure/coverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure/coverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure/coverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
• Ages 18 - 64 years inclusive
• Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• Patients may have a traumatic brain injury.
• Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur, or foot injuries.
• Patients may be treated initially at an outside institution prior to transferring to the study institution, as long as the definitive wound closure/coverage was not performed prior to entrance into the study.
• 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.
• Patients may have co-existing non-tibial or hindfoot infections, with or without antibiotic treatment.
• Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast).
• Patients may have fasciotomy.

You may not qualify if…

• Patient speaks neither English or Spanish
• Patient in current therapy for a wound, implant or fracture site infection related to the study site.
• Patient is pregnant, potentially pregnant, or lactating.
• 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, unless willing to follow-up by phone or telemedicine
• Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine
• Being a prisoner
• Not having a means of contact (address, cell phone, home phone, e-mail)

Where it is running

• Stanford University — Redwood City, California, United States (enrolling)
• _University of California, San Francisco — San Francisco, California, United States (enrolling)
• University of California at San Francisco — San Francisco, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• St Mary's University/Tenent Health — West Palm Beach, Florida, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• Indiana University School of Medicine - Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• Indiana University/Eskenazi Health — Indianapolis, Indiana, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• LSU Health Sciences — New Orleans, Louisiana, United States (enrolling)
• University of Maryland , MD Department of Orthopaedics — Baltimore, Maryland, United States (enrolling)
• Walter Reed Military Medical Center — Bethesda, Maryland, United States (enrolling)
• Harvard/Mass General/Brigham Hospitals — Boston, Massachusetts, United States (enrolling)
• Hennepin County Medical Center / Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Dartmouth Hitchcock — Lebanon, New Hampshire, United States (enrolling)
• Jamaica Hospital Medical Center — Jamaica, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
• METROHealth — Cleveland, Ohio, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• University of Oklahoma College of Medicine — Oklahoma City, Oklahoma, United States (enrolling)
• Temple University — Philadelphia, Pennsylvania, United States (enrolling)
• Brown University/Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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