Menu
Not yet recruiting NCT06920147

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

Phase IV Interventional Surgical Site Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ertapenem, Cefazolin and Metronidazole..
Who it may be relevant to
Registry conditions: Surgical Site Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Number of participants that have post-laparotomy OS-SSIs [Time frame: 30 days after surgery]
Secondary outcome measures (6)
  • Number of participants that have superficial incisional SSIs [Time frame: 30 days after surgery]
  • Number of participants that have deep incisional SSIs [Time frame: 30 days after surgery]
  • Number of patients that show highest Clavien-Dindo grade for OS-SSIs [Time frame: 30 days after surgery]
  • Number of unplanned reoperations [Time frame: 30 days after surgery]
  • Number of readmissions [Time frame: 30 days after surgery]
  • Number of participants that have Clostridium difficile infections [Time frame: 30 days after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06920147 · HSC-MS-24-0212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗