Health TrialsbyHealthPanel

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT

ConditionPost Operative Surgical Site Infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Standard of care

    Drug

    Participants in the control group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.

  • Vancomycin and Tobramycin

    Drug

    The patients in the SEXTANT cohort 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. The SEXTANT cohort will then receive at least 72 hours of systemic antibiotic therapy targeted to the modern wound bioburden.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Deep surgical site infection

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.

Time frame
182 days from injury

Secondary outcomes

1

Deep surgical site infection

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.

Time frame
365 days from injury
2

Fracture revision rates

Fracture revision rates for non-union, flap failure, amputation, the development of resistant bacteria discovered at revision surgery and antibiotic-related complications (C. difficile, nephrotoxicity, ototoxicity).

Time frame
365 days from injury

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Major Extremity Trauma Research Consortium

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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