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

NCT06920147 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: HSC-MS-24-0212
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants that have post-laparotomy OS-SSIs

  30 days after surgery

Secondary Outcomes (6)

• Number of participants that have superficial incisional SSIs

  30 days after surgery

• Number of participants that have deep incisional SSIs

  30 days after surgery

• Number of patients that show highest Clavien-Dindo grade for OS-SSIs

  30 days after surgery

• Number of unplanned reoperations

  30 days after surgery

• Number of readmissions

  30 days after surgery

Study Arms (2)

Ertapenem only

EXPERIMENTAL

Drug: Ertapenem

Combination of cefazolin and metronidazole.

EXPERIMENTAL

Drug: Cefazolin and Metronidazole.

Interventions

Ertapenem 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

Ertapenem only

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

Combination of cefazolin and metronidazole.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma laparotomy within 90 minutes of arrival

You may not qualify if:

• Patients with a known allergy to cephalosporins or β-lactamase inhibitors
• Prisoners
• Pregnant and lactating women

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Surgical Infection Society: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ertapenem; Cefazolin; Metronidazole

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; Thiazines; Sulfur Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Lillian S Kao, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lillian S Kao, MD

CONTACT

(713) 500-6280; Lillian.S.Kao@uth.tmc.edu

Erin E Fox, PhD

CONTACT

713 500 7965; erin.e.fox@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)