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

Phase 4

Not yet recruiting

• Conditions: Surgical Site Infection
• Interventions: Drug: Ertapenem; Drug: Cefazolin and Metronidazole.

• Registration Number: NCT06920147
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-11
• Study Start: 2025-05-01
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ertapenem only	Ertapenem	-
Combination of cefazolin and metronidazole.	Cefazolin and Metronidazole.	-

Primary Outcome Measures

Name	Time	Method
Number of participants that have post-laparotomy OS-SSIs	30 days after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States