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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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Injury meeting at least one of the following criteria:
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 criteria
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:
Primary purpose
Allocation
Interventional model
Masking
1,200 participants in 2 patient groups
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Central trial contact
Susan C Collins, MSc; Suna Chung, MPH
Data sourced from clinicaltrials.gov
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