PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network
NCT ID: NCT06920147
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2025-05-01
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Ertapenem only
Ertapenem
Participants will receive a single dose of IV ertapenem (1g) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status
Combination of cefazolin and metronidazole.
Cefazolin and Metronidazole.
Participants will receive a single dose of a combination of IV cefazolin (re-dosed during the case every 4 hours and/or after every 1,500 mL of blood loss) and IV metronidazole (single dose 500 mg) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status
Interventions
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Ertapenem
Participants will receive a single dose of IV ertapenem (1g) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status
Cefazolin and Metronidazole.
Participants will receive a single dose of a combination of IV cefazolin (re-dosed during the case every 4 hours and/or after every 1,500 mL of blood loss) and IV metronidazole (single dose 500 mg) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prisoners
* Pregnant and lactating women
18 Years
ALL
No
Sponsors
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Surgical Infection Society
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Lillian Kao
Professor
Principal Investigators
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Lillian S Kao, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-24-0212
Identifier Type: -
Identifier Source: org_study_id
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