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NCT Number: NCT06920147

PRevention Of Trauma-related Infections Through an Embedded Clinical Trials 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Number of participants that have post-laparotomy OS-SSIs

    Time frame: 30 days after surgery

Secondary outcomes

  1. Number of participants that have superficial incisional SSIs

    Time frame: 30 days after surgery

  2. Number of participants that have deep incisional SSIs

    Time frame: 30 days after surgery

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

    Time frame: 30 days after surgery

    grades range from I (minor, requiring no intervention) to V (death)

  4. Number of unplanned reoperations

    Time frame: 30 days after surgery

  5. Number of readmissions

    Time frame: 30 days after surgery

  6. Number of participants that have Clostridium difficile infections

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Erin E Fox, PhD

CONTACT

[email protected]

713 500 7965

Lillian S Kao, MD

CONTACT

[email protected]

(713) 500-6280

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Surgical Infection Society

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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