PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Trauma laparotomy within 90 minutes of arrival Exclusion Criteria: * Patients with a known allergy to cephalosporins or β-lactamase inhibitors * Prisoners * Pregnant and lactating women
Interventions
- DrugErtapenem
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
- DrugCefazolin 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
Location
- The University of Texas Health Science Center at HoustonHouston, Texas