RecruitingPhase 3

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

United States1,200 participantsStarted 2021-05-07

Plain-language summary

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.

Who can participate

Age range18 Years – 64 Years

SexALL

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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 transfer to the study institution, as long as the definitive wound closure or coverage was not performed prior to entrance into the study.
✓. 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 infection, with or without antibiotic treatment.

Exclusion criteria

✕. Patient in current therapy for a wound, implant or fracture site infection related to the study site.
✕. Patient likely to have difficulty maintaining follow-up, including:

What they're measuring

Deep surgical site infection

Timeframe: 182 days from injury

Trial details

NCT IDNCT04678154

SponsorMajor Extremity Trauma Research Consortium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Suna Chung, MPH

4105023357 schung60@jhu.edu

View on ClinicalTrials.gov More Post Operative Surgical Site Infection trials