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

Phase 3

Recruiting

• Conditions: Post Operative Surgical Site Infection
• Interventions: Drug: Vancomycin and Tobramycin; Drug: Standard of care

• Registration Number: NCT04678154
• Lead Sponsor: Major Extremity Trauma Research Consortium

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Study Start: 2021-05-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-09-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion 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.

Exclusion Criteria

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
Deep surgical site infection	182 days from injury	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.

Secondary Outcome Measures

Name	Time	Method
Deep surgical site infection	365 days from injury	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.
Fracture revision rates	365 days from injury	Fracture revision rates for non-union, flap failure, amputation, the development of resistant bacteria discovered at revision surgery and antibiotic-related complications (C. difficile, nephrotoxicity, ototoxicity).

Trial Locations

Locations (31)

Stanford University; 🇺🇸 Redwood City, California, United States

_University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

St Mary's University/Tenent Health; 🇺🇸 West Palm Beach, Florida, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Indiana University School of Medicine - Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University/Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

LSU Health Sciences; 🇺🇸 New Orleans, Louisiana, United States

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