Status:
RECRUITING
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Lead Sponsor:
Major Extremity Trauma Research Consortium
Collaborating Sponsors:
United States Department of Defense
Conditions:
Post Operative Surgical Site Infection
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 transfer to the study institution, as long as the definitive wound closure or 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 infection, with or without antibiotic treatment.
- Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
- Patients may have a fasciotomy.
Exclusion
- Patient in current therapy for a wound, implant or fracture site infection related to the study site.
- 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)
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04678154
Start Date
May 7 2021
End Date
March 31 2027
Last Update
May 13 2025
Active Locations (31)
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1
Stanford University
Redwood City, California, United States, 94063
2
_University of California, San Francisco
San Francisco, California, United States, 94110
3
University of California at San Francisco
San Francisco, California, United States, 94110
4
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045