Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 (NCT04678154) | Clinical Trial Compass
RecruitingPhase 3
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
United States600 participantsStarted 2021-05-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 transferring to the study institution, as long as the definitive wound closure/coverage was not performed prior to entrance into the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically about severe open fractures — does my fracture qualify as the type of open fracture this study is looking for, and what exactly makes a fracture 'severe' in the context of this trial?
2The study is testing a new 'protocolized' antibiotic strategy, which means a structured, standardized approach to giving antibiotics — can you explain how this differs from the antibiotic treatment I would receive outside the trial, and what the potential risks or unknowns are since this is still being evaluated in a Phase 3 study?
3Since the main thing this trial is measuring is deep surgical site infection, can you tell me what my current risk of that complication is, and how the trial's antibiotic protocol might compare to what's already known to work for preventing it?
4Given that this trial is actively recruiting, how would participation affect the timing and decisions around my fracture surgery — for example, would I be enrolled and randomized before or after my operation, and could that affect my care in ways I should be aware of?
5Are there standard-of-care antibiotic options already available for my situation that we should consider first, or do you think participating in this trial could offer me access to a potentially better-managed approach that's worth discussing seriously?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Deep surgical site infection
Timeframe: 180 days from final wound closure/cloverage
. 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.
Exclusion criteria
. 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