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

Purpose

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.

Condition

  • Post Operative Surgical Site Infection

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control 		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: 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.
Experimental
Treatment 		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.
  • 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.

Recruiting Locations

Stanford University
Redwood City 5386834, California 5332921 94063
Contact:
Carina Tedesco
650-723-8386
ctedesco@stanford.edu

_University of California, San Francisco
San Francisco 5391959, California 5332921 94110
Contact:
Eleni Berhaneselase
415-476-2124
eleni.berhaneselase@ucsf.edu

University of California at San Francisco
San Francisco 5391959, California 5332921 94110
Contact:
Eleni Berhaneselase
Eleni.Berhaneselase@ucsf.edu

University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
Fahim Choudhury
(303) 724-3185
fahim.choudhury@cuanschutz.edu

St Mary's University/Tenent Health
West Palm Beach 4177887, Florida 4155751 33407
Contact:
Tracy Rodriguez
561-882-6386
tracy.rodriguez@tenethealth.com

Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30303

Indiana University School of Medicine - Methodist Hospital
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Maricella Diaz
317.963.5034
diaz4@iu.edu

Indiana University/Eskenazi Health
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Molly Moore
317-880-3581
momfreed@iupui.edu

University of Kentucky
Lexington 4297983, Kentucky 6254925 40506
Contact:
Matthew Eubank
(859)562-3428
mseuba01@uky.edu

LSU Health Sciences
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Jessica Rivera
jrive5@lsuhsc.edu

University of Maryland , MD Department of Orthopaedics
Baltimore 4347778, Maryland 4361885 21201
Contact:
Yasmin Degani, MPH
ydegani@som.umaryland.edu

Walter Reed Military Medical Center
Bethesda 4348599, Maryland 4361885 20889
Contact:
Heather Decot
(301) 295-4568
heather.k.decot.ctr@health.mil

Harvard/Mass General/Brigham Hospitals
Boston 4930956, Massachusetts 6254926 02115
Contact:
Thiru Wignakumar
twignakumar@bwh.harvard.edu

Hennepin County Medical Center / Minneapolis
Minneapolis 5037649, Minnesota 5037779 55415

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Contact:
Sandra Powe
601-815-1045
spowe@umc.edu

Dartmouth Hitchcock
Lebanon 5088597, New Hampshire 5090174 03766
Contact:
Devin Mullin
devin.s.mullin@hitchcock.org

Jamaica Hospital Medical Center
Jamaica 5122520, New York 5128638 11418

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
Nevaeh Nez
nevaeh_nez@med.unc.edu

Atrium Health Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348 28203
Contact:
Christine Churchill

Atrium Health Wake Forest Baptist
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Martha Holden
336.716.5457
mholden@wakehealth.edu

METROHealth
Cleveland 5150529, Ohio 5165418 44109
Contact:
Anna Vergon
216-778-3656
avergon@metrohealth.org

Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43201
Contact:
Jessica Wiseman
614-293-2064
jessica.wiseman@osumc.edu

University of Oklahoma College of Medicine
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Lyndee Nguyen
405-271-4426
lyndee-nguyen@ouhsc.edu

Temple University
Philadelphia 4560349, Pennsylvania 6254927 19140
Contact:
Adam Lloyd-Jones
267-643-5067
adam.lloyd-jones@temple.edu

Brown University/Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02905

Rhode Island Hospital/Brown University
Providence 5224151, Rhode Island 5224323 02905
Contact:
MJ Crisco
401-457-2189
mjcrisco@uoi.com

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Karen Trochez
karen.m.trochez@Vanderbilt.Edu

University of Texas Health Science Center - Houston
Houston 4699066, Texas 4736286 77030
Contact:
Sterling Boutte
Sterling.Boutte@uth.tmc.edu

University of Virginia
Charlottesville 4752031, Virginia 6254928 22903
Contact:
Eric McVey
434.243.5382
EDM9U@hscmail.mcc.virginia.edu

Inova Fairfax MEdical Campus
Falls Church 4758390, Virginia 6254928 22042
Contact:
Senay Ghidei
(703) 526-4382
Senay.Ghidei@Inova.org

Virginia Commonwealth University Medical Center
Richmond 4781708, Virginia 6254928 23298
Contact:
Caleb Bridgman
804.628.3584
Caleb.Bridgwater@vcuhealth.org

More Details

NCT ID
NCT04678154
Status
Recruiting
Sponsor
Major Extremity Trauma Research Consortium

Study Contact

Suna Chung, MPH
4105023357
schung60@jhu.edu

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.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center