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

NCT06920147 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-04-11

No results posted yet for this study

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

Conditions

  • Surgical Site Infection

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Surgical Infection Society

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Lillian S Kao, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920147 on ClinicalTrials.gov