Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMajor Extremity Trauma Research Consortium
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Diagnosis of a severe psychiatric condition
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of care
DrugParticipants in the control group will receive standard care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Topical antibiotics are allowed, if SOC for the institution, but are not mandated.
Vancomycin and Tobramycin
DrugThe patients in the SEXTANT cohort will receive 72 hours of targeted systemic antibiotic therapy (Table 2) and will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site, and exposed hardware (if any) just prior to suture closure of the wound or flap. 72-hour of systemic gram-positive and gram-negative antibiotic coverage to target the terminal wound bioburden. The antibiotics coverage proposed as the primary choice includes PO Ciprofloxacin + PO linezolid or IV Ciprofloxacin and IV Vancomycin. The preferred antibiotic regimen will be decided by study's ID team, in cooperation with the ID and Antibiotic Stewardship teams at each site. Antibiotic recommendations will be adjusted, if needed, to account for a Site's bacteria susceptibility / resistance profile, or the specific needs of an individual patient.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Deep surgical site infection
To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed.
Time frame
180 days from final wound closure/cloverageSponsors and contacts
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Major Extremity Trauma Research Consortium
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov