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PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network
Sponsor: The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables
Official title: PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-05-01
Completion Date
2027-03-31
Last Updated
2025-04-11
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States