Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
K
Karl Shively
Primary Investigator
L
Luke A. Lopas, MD
Primary Investigator
Overview
The proposed study is a multi-center, prospective randomized controlled trial comparingurrent standard of care treatment to the SEXTANT treatment protocol in patients with Typeures of the tibia and IIIB fractures of the ankle and hindfoot.
Description
Specific Aim 1: To compare the surgical site infection (SSI) rates of the current severe openure antibiotic strategy to a revised SEXTANT treatment strategy designed to address thedern 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 definitiveure or coverage as sampled by standard tissue microbiology.
Specific Aim 3: To compare rates of antibiotic-related serious adverse events (SAEs) of thewo treatment groups.
Exploratory Aim 4: To pilot the use of available and emerging rapid PCR platforms for woundhogen identification in a sub-cohort of patients.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Post Operative Surgical Site Infection
-
Age: Between 18 Years - 64 Years
-
Gender: All
Inclusion Criteria:
- Injury meeting at least one of the following criteria:
- Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon) requiringd procedure for final debridement and definitive coverage / closurewing 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 flapverage
- Ages 18 - 64 years inclusive
- Patients may have risk factors for infection including diabetes, immunosuppressionds or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may have other fractures including spine, upper extremity fractures,wer extremity injuries, ipsilateral pelvis, hip, femur or footjuries.
- Patients may be treated initially at an outside institution prior to transfer to theudy institution, as long as the definitive wound closure or coverage was notd prior to entrance into the study.
- Patients with bilateral injuries that meet inclusion criteria may be included, buty the limb rated as "more severe" by the treating surgeon will be enrolled in theudy.
- Patients may have co-existing non-tibial or hindfoot infection, with or withoutbiotic treatment.
- Patients may be definitively stabilized using any method (nail, plate, ex fix or).
- Patients may have a fasciotomy.
Exclusion Criteria:
- Patient in current therapy for a wound, implant or fracture site infection related tohe study site.
- 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)
Updated on
29 Apr 2024.
Study ID: W81XWH-19-2-0062
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