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New antibiotic care strategy for severe open fractures

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial

Phase 3 Interventional Major Extremity Trauma Research Consortium · NCT04678154

This study is testing a new antibiotic treatment plan for people with severe open fractures in their legs and ankles to see if it helps reduce infections and improve healing compared to the usual care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1200 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorMajor Extremity Trauma Research Consortium Academic / other
Locations31 sites (Redwood City, California and 30 other locations)
Trial IDNCT04678154 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective randomized controlled trial aims to evaluate the effectiveness of the SEXTANT treatment protocol compared to the current standard of care for patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot. The study will assess surgical site infection rates, terminal bioburden of wounds, and antibiotic-related serious adverse events between the two treatment groups. Additionally, it will explore the use of rapid PCR platforms for identifying wound pathogens in a subset of patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-64 with Type III tibia or IIIB ankle fractures requiring surgical intervention.

Not a fit: Patients with non-severe fractures or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the rates of surgical site infections in patients with severe open fractures.

How similar studies have performed: Other studies have shown promising results with similar antibiotic strategies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Injury meeting at least one of the following criteria:

   * 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)
   * Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
2. Ages 18 - 64 years inclusive
3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
4. Patients may have a traumatic brain injury.
5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
6. 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.
7. 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.
8. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
9. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
10. Patients may have a fasciotomy.

Exclusion Criteria:

1. Patient in current therapy for a wound, implant or fracture site infection related to the study site.
2. 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
   * Planning to follow-up at another medical center
   * Being a prisoner
   * Not having a means of contact (address, cell phone, home phone, e-mail)

Where this trial is running

Redwood City, California and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Post Operative Surgical Site InfectionSurgical site infection risk preventionBacterial species type and antibacterial sensitivities
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.