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

ConditionSurgical Site Infection
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Trauma laparotomy within 90 minutes of arrival

Disqualifiers

Patients with a known allergy to cephalosporins or β-lactamase inhibitors

Prisoners

Pregnant and lactating women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Ertapenem onlyExperimental treatment 1 intervention
Group B: Combination of cefazolin and metronidazole.Experimental treatment 1 intervention

Trial outcomes

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

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

Time frame
30 days after surgery
4

Number of unplanned reoperations

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Surgical Infection Society

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: