Clinical trial NCT04678154: Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Official title: Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Post Operative Surgical Site Infection
Keywords: Surgical site infection risk prevention
Bacterial species type and antibacterial sensitivities
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-12-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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:

1. 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)

Primary outcomes:
measure: Deep surgical site infection
timeFrame: 182 days from injury
Secondary outcomes:
measure: Deep surgical site infection
timeFrame: 365 days from injury
measure: Fracture revision rates
timeFrame: 365 days from injury
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: _University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: West Palm Beach
country: United States
facility: St Mary's University/Tenent Health
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University/Eskenazi Health
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland , MD Department of Orthopaedics
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Harvard/Mass General/Brigham Hospitals
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center / Minneapolis
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Lebanon
country: United States
facility: Dartmouth Hitchcock
state: New Hampshire
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cleveland
country: United States
facility: METROHealth
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Providence
country: United States
facility: Brown University/Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital/Brown University
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center - Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax MEdical Campus
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Carolinas Medical Center
name: Micahel J Bosse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atrium Health Musculoskeletal Institute Research
name: Rachel Seymour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Renan C Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Anthony R Carlini, MS
role: PRINCIPAL_INVESTIGATOR
References: