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

Primary Purpose

Post Operative Surgical Site Infection

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard of care
Vancomycin and Tobramycin
Sponsored by
Major Extremity Trauma Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Surgical Site Infection focused on measuring Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Atrium Health Carolinas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Deep surgical site infection
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

Deep surgical site infection
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
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).

Full Information

First Posted
December 11, 2020
Last Updated
August 22, 2022
Sponsor
Major Extremity Trauma Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT04678154
Brief Title
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Official Title
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Major Extremity Trauma Research Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Surgical Site Infection
Keywords
Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vancomycin and Tobramycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Deep surgical site infection
Description
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.
Time Frame
182 days from injury
Secondary Outcome Measure Information:
Title
Deep surgical site infection
Description
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.
Time Frame
365 days from injury
Title
Fracture revision rates
Description
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).
Time Frame
365 days from injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 Ages 18 - 64 years inclusive Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections. Patients may have a traumatic brain injury. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries. 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. 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. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast). Patients may have a fasciotomy. Exclusion Criteria: Patient in current therapy for a wound, implant or fracture site infection related to the 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suna Chung, MPH
Phone
4105023357
Email
schung60@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susan C Collins, MSc
Phone
410-502-8966
Email
scolli21@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Micahel J Bosse, MD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Seymour, PhD
Organizational Affiliation
Atrium Health Musculoskeletal Institute Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renan C Castillo, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony R Carlini, MS
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Churchill

12. IPD Sharing Statement

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

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