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

a study on Post Operative Surgical Site Infection Surgical Wound Infection

Summary

Eligibility
for people ages 18-64 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Saam Morshed, MD

Description

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.

Official Title

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

Details

Specific Aim 1: To compare the surgical site infection (SSI) rates of the current severe open fracture antibiotic strategy to a revised SEXTANT treatment strategy designed to address the modern wound bioburden at the time of wound closure or coverage.

Specific Aim 2: To compare the terminal bioburden of the wounds at the time of definitive closure or coverage as sampled by standard tissue microbiology.

Specific Aim 3: To compare rates of antibiotic-related serious adverse events (SAEs) of the two treatment groups.

Exploratory Aim 4: To pilot the use of available and emerging rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.

Keywords

Post Operative Surgical Site Infection, Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities, Surgical Wound Infection, Open Fractures, Vancomycin, Tobramycin, Vancomycin and Tobramycin

Eligibility

You can join if…

Open to people ages 18-64

  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.

You CAN'T join if...

  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)

Locations

  • _University of California, San Francisco accepting new patients
    San Francisco California 94110 United States
  • University of California at San Francisco accepting new patients
    San Francisco California 94110 United States
  • Stanford University accepting new patients
    Redwood City California 94063 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Major Extremity Trauma Research Consortium
ID
NCT04678154
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1200 study participants
Last Updated
Contact us about this trial