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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Post Operative Surgical Site Infection
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University, Redwood City, California, United States, 94063

San Francisco

_University of California, San Francisco, San Francisco, California, United States, 94110

San Francisco

University of California at San Francisco, San Francisco, California, United States, 94110

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

West Palm Beach

St Mary's University/Tenent Health, West Palm Beach, Florida, United States, 33407

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30303

Indianapolis

Indiana University School of Medicine - Methodist Hospital, Indianapolis, Indiana, United States, 46202

Indianapolis

Indiana University/Eskenazi Health, Indianapolis, Indiana, United States, 46202

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40506

New Orleans

LSU Health Sciences, New Orleans, Louisiana, United States, 70112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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)

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Major Extremity Trauma Research Consortium,

Micahel J Bosse, MD, PRINCIPAL_INVESTIGATOR, Carolinas Medical Center

Rachel Seymour, PhD, PRINCIPAL_INVESTIGATOR, Atrium Health Musculoskeletal Institute Research

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

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

Study Record Dates

2025-03-30