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Antibiotic

Antibiotic Care for Fractures

Phase 3

Recruiting

Led By Renan C Castillo, PhD

Research Sponsored by Major Extremity Trauma Research Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gustilo type IIIB talus fractures (OTA 81)

Ages 18 - 64 years inclusive

Must not have

Patient in current therapy for a wound, implant or fracture site infection related to the study site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days from injury

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare a new treatment protocol to the current standard of care for patients with certain types of fractures.

Who is the study for?

Adults aged 18-64 with severe open fractures of the tibia, ankle, or hindfoot that require further surgery after initial stabilization. Suitable for those with additional injuries or risk factors like diabetes and immunosuppression. Not for intellectually challenged individuals without support, those unlikely to follow up due to location or lack of contact means, prisoners, or patients already receiving infection treatment at the study site.

What is being tested?

The SEXTANT trial is comparing standard care against a new protocol involving Vancomycin and Tobramycin in treating Type III open fractures. It's a multi-center study where participants are randomly chosen to receive either the current standard treatment or the experimental antibiotic regimen.

What are the potential side effects?

Potential side effects may include allergic reactions to antibiotics (like rashes), kidney issues from Tobramycin, hearing problems also related to Tobramycin, and possible antibiotic resistance leading to less effective treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe ankle fracture.

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I am between 18 and 64 years old.

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I have a severe heel bone fracture.

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I need surgery for my below-knee amputation wound.

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I have a severe open ankle fracture.

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I need a second surgery for my severe lower leg injury after the first stabilization.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently being treated for an infection at the site related to the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days from injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days from injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days from injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Deep surgical site infection

Fracture revision rates

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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.

0 / 7Eligibility criteria met