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

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: Ertapenem; Drug: Cefazolin and Metronidazole.

Study type: Interventional

Funder types: Other

Identifiers

NCT06920147

HSC-MS-24-0212

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Ertapenem only

Experimental group

Treatment:

Drug: Ertapenem

Combination of cefazolin and metronidazole.

Experimental group

Treatment:

Drug: Cefazolin and Metronidazole.