New antibiotic care strategy for severe open fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, prospective randomized controlled trial aims to evaluate the effectiveness of the SEXTANT treatment protocol compared to the current standard of care for patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot. The study will assess surgical site infection rates, terminal bioburden of wounds, and antibiotic-related serious adverse events between the two treatment groups. Additionally, it will explore the use of rapid PCR platforms for identifying wound pathogens in a subset of patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Injury meeting at least one of the following criteria:

   a. Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and/or talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure / coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and/or fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure/coverage is allowed) vi. IIIA fractures with AO/OTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure/coverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure/coverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure/coverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. 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 transferring to the study institution, as long as the definitive wound closure/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 infections, with or without antibiotic treatment.
9. Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast).
10. Patients may have fasciotomy.

Exclusion Criteria:

1. Patient speaks neither English or Spanish
2. Patient in current therapy for a wound, implant or fracture site infection related to the study site.
3. Patient is pregnant, potentially pregnant, or lactating.
4. Patient likely to have difficulty maintaining follow-up, including:

   1. Diagnosis of a severe psychiatric condition
   2. Intellectually challenged without adequate family support
   3. Resides outside of the hospital's catchment area, unless willing to follow-up by phone or telemedicine
   4. Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine
   5. Being a prisoner
   6. Not having a means of contact (address, cell phone, home phone, e-mail)

Where it's running

• Stanford University
  Redwood City, California, United States Recruiting
• _University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of California at San Francisco
  San Francisco, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• St Mary's University/Tenent Health
  West Palm Beach, Florida, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Micahel J Bosse, MD — Carolinas Medical Center
• Study coordinator: Suna Chung, MPH
• Email: schung60@jhu.edu
• Phone: 4105023357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.