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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06920147
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Surgical Site Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Ertapenem only
  • Experimental: Combination of cefazolin and metronidazole.

Primary Outcome Measure

Number of participants that have post-laparotomy OS-SSIs [ Time Frame: 30 days after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Lillian S Kao, MD
[email protected]
713-500-6280
Erin E Fox, PhD
[email protected]
713 500 7965

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