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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Ertapenem; Drug: Cefazolin and Metronidazole.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lillian S Kao, MD; Phone Number: (713) 500-6280; Email: Lillian.S.Kao@uth.tmc.edu
• Study Contact Backup: Name: Erin E Fox, PhD; Phone Number: 713 500 7965; Email: erin.e.fox@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Erin E Fox, PhD; Phone Number: 713 500 7965; Email: erin.e.fox@uth.tmc.edu
      • Contact: Lillian S Kao, MD; Phone Number: 713-500-6280; Email: Lillian.S.Kao@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ertapenem only	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
Experimental: Combination of cefazolin and metronidazole.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that have post-laparotomy OS-SSIs	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	grades range from I (minor, requiring no intervention) to V (death)	30 days after surgery
Number of unplanned reoperations		30 days after surgery
Number of readmissions		30 days after surgery
Number of participants that have Clostridium difficile infections		30 days after surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Surgical Infection Society
• Investigators: Principal Investigator: Lillian S Kao, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Bacterial Agents; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Ertapenem; Metronidazole; Cefazolin
• Other Study ID Numbers: HSC-MS-24-0212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No