NCT04678154

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Surgical Site Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-07
• Primary completion: 2026-09-30
• Completion: 2027-03-31
• First posted: 2020-12-21
• Last updated: 2025-05-13

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study