Surgical Site Infection
Conditions
Brief 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
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
Sponsors
Surgical Infection Society
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants that have post-laparotomy OS-SSIs | 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that have deep incisional SSIs | 30 days after surgery | — |
| Number of patients that show highest Clavien-Dindo grade for OS-SSIs | 30 days after surgery | grades range from I (minor, requiring no intervention) to V (death) |
| Number of participants that have superficial incisional SSIs | 30 days after surgery | — |
| Number of readmissions | 30 days after surgery | — |
| Number of participants that have Clostridium difficile infections | 30 days after surgery | — |
| Number of unplanned reoperations | 30 days after surgery | — |
Countries
United States
Contacts
Primary ContactLillian S Kao, MD
Backup ContactErin E Fox, PhD
Outcome results
None listed