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NOT YET RECRUITING
NCT06920147
PHASE4

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

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-05-01

Completion Date

2027-03-31

Last Updated

2025-04-11

Healthy Volunteers

No

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States