RECRUITING

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

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Conditions

Post Operative Surgical Site InfectionSurgical site infection risk preventionBacterial species type and antibacterial sensitivities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-07
Study Completion:2025-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04678154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Injury meeting at least one of the following criteria:
  2. * 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
  3. * Gustilo type IIIB ankle fractures (OTA 44)
  4. * Gustilo type IIIB calcaneus fractures (OTA 82)
  5. * Gustilo type IIIB talus fractures (OTA 81)
  6. * Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
  7. 2. Ages 18 - 64 years inclusive
  8. 3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
  9. 4. Patients may have a traumatic brain injury.
  10. 5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
  11. 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.
  12. 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.
  13. 8. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
  14. 9. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
  15. 10. Patients may have a fasciotomy.
  1. 1. Patient in current therapy for a wound, implant or fracture site infection related to the study site.
  2. 2. Patient likely to have difficulty maintaining follow-up, including:
  3. * Diagnosis of a severe psychiatric condition
  4. * Intellectually challenged without adequate family support
  5. * Resides outside of the hospital's catchment area
  6. * Planning to follow-up at another medical center
  7. * Being a prisoner
  8. * Not having a means of contact (address, cell phone, home phone, e-mail)

Contacts and Locations

Study Contact

Suna Chung, MPH
CONTACT
4105023357
schung60@jhu.edu
Susan C Collins, MSc
CONTACT
410-502-8966
scolli21@jhu.edu

Principal Investigator

Micahel J Bosse, MD
PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Rachel Seymour, PhD
PRINCIPAL_INVESTIGATOR
Atrium Health Musculoskeletal Institute Research
Renan C Castillo, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Anthony R Carlini, MS
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

Stanford University
Redwood City, California, 94063
United States
_University of California, San Francisco
San Francisco, California, 94110
United States
University of California at San Francisco
San Francisco, California, 94110
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
St Mary's University/Tenent Health
West Palm Beach, Florida, 33407
United States
Emory University School of Medicine
Atlanta, Georgia, 30303
United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, 46202
United States
Indiana University/Eskenazi Health
Indianapolis, Indiana, 46202
United States
University of Kentucky
Lexington, Kentucky, 40506
United States
LSU Health Sciences
New Orleans, Louisiana, 70112
United States
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, 21201
United States
Walter Reed Military Medical Center
Bethesda, Maryland, 20889
United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766
United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
METROHealth
Cleveland, Ohio, 44109
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43201
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73104
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Brown University/Rhode Island Hospital
Providence, Rhode Island, 02905
United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, 02905
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Texas Health Science Center - Houston
Houston, Texas, 77030
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Inova Fairfax MEdical Campus
Falls Church, Virginia, 22042
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

  • Micahel J Bosse, MD, PRINCIPAL_INVESTIGATOR, Carolinas Medical Center
  • Rachel Seymour, PhD, PRINCIPAL_INVESTIGATOR, Atrium Health Musculoskeletal Institute Research
  • Renan C Castillo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health
  • Anthony R Carlini, MS, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-07
Study Completion Date2025-03-30

Study Record Updates

Study Start Date2021-05-07
Study Completion Date2025-03-30

Terms related to this study

Keywords Provided by Researchers

  • Surgical site infection risk prevention
  • Bacterial species type and antibacterial sensitivities

Additional Relevant MeSH Terms

  • Post Operative Surgical Site Infection