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

NCT ID: NCT06920147

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ertapenem only

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

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

Combination of cefazolin and metronidazole.

Group Type EXPERIMENTAL

Cefazolin and Metronidazole.

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Surgical Infection Society

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Lillian Kao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lillian S Kao, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Lillian S Kao, MD

Role: CONTACT

(713) 500-6280

Erin E Fox, PhD

Role: CONTACT

713 500 7965

Facility Contacts

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Lillian S Kao, MD

Role: primary

713-500-6280

Erin E Fox, PhD

Role: backup

713 500 7965

Other Identifiers

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HSC-MS-24-0212

Identifier Type: -

Identifier Source: org_study_id

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