PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network

Phase 4Not Yet RecruitingNCT06920147

The University of Texas Health Science Center, Houston300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

300

Conditions

Surgical Site Infection

Interventions

ErtapenemDRUG

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.DRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States