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

NCT04678154 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

  • Post Operative Surgical Site Infection

Interventions

DRUG

Standard of care

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.

DRUG

Vancomycin and Tobramycin

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Micahel J Bosse, MD · Carolinas Medical Center

  • Rachel Seymour, PhD · Atrium Health Musculoskeletal Institute Research

  • Renan C Castillo, PhD · Johns Hopkins Bloomberg School of Public Health

  • Anthony R Carlini, MS · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678154 on ClinicalTrials.gov