Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMajor Extremity Trauma Research Consortium
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Patient in current therapy for a wound, implant or fracture site infection related to the study site.
Diagnosis of a severe psychiatric condition
Intellectually challenged without adequate family support
Resides outside of the hospital's catchment area
Trial design
Treatments tested in this trial
- Standard of care
- Vancomycin and Tobramycin
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Major Extremity Trauma Research Consortium
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov