Surgical Site InfectionPhase 4PROTECTNCT06920147
PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network
A Phase 4 study testing Ertapenem and Cefazolin and Metronidazole. in people with Surgical Site Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Ertapenem and Cefazolin and Metronidazole.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma laparotomy within 90 minutes of arrival
Who cannot join
- Patients with a known allergy to cephalosporins or β-lactamase inhibitors
- Prisoners
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lillian S Kao, MD, 713-500-6280, Lillian.S.Kao@uth.tmc.edu
Erin E Fox, PhD, 713 500 7965, erin.e.fox@uth.tmc.edu
About this study
Official title: PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) 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
- Conditions
- Surgical Site Infection
- Being tested
- Ertapenem, Cefazolin and Metronidazole.
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
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 group | Role | What they receive |
|---|---|---|
| Ertapenem only | Experimental | Not described Receives: Drug: Ertapenem |
| Combination of cefazolin and metronidazole. | Experimental | Not described Receives: Drug: Cefazolin and Metronidazole. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have post-laparotomy OS-SSIs
Measured: 30 days after surgery
Secondary outcomes (6)
Number of participants that have superficial incisional SSIs
Measured: 30 days after surgery
Number of participants that have deep incisional SSIs
Measured: 30 days after surgery
Number of patients that show highest Clavien-Dindo grade for OS-SSIs
grades range from I (minor, requiring no intervention) to V (death)
Measured: 30 days after surgery
Number of unplanned reoperations
Measured: 30 days after surgery
Number of readmissions
Measured: 30 days after surgery
Number of participants that have Clostridium difficile infections
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Surgical Infection Society
- Responsible party
- Principal investigator, Lillian Kao, The University of Texas Health Science Center, Houston
- Investigators
- Lillian S Kao, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920147
- Sponsor's protocol ID
- HSC-MS-24-0212
- Acronym
- PROTECT
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network
- ClinicalTrials.gov ID
- NCT06920147
- Acronym / sponsor ID
- PROTECT / HSC-MS-24-0212
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Surgical Infection Society
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem only | Experimental | Drug: Ertapenem |
| Combination of cefazolin and metronidazole. | Experimental | Drug: Cefazolin and Metronidazole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trauma laparotomy within 90 minutes of arrival
Key exclusion criteria (3 listed)
- Patients with a known allergy to cephalosporins or β-lactamase inhibitors
- Prisoners
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErtapenemParticipants 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 | Ertapenem only |
| 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 | Drug | Combination of cefazolin and metronidazole. |
Primary outcome
Number of participants that have post-laparotomy OS-SSIs
Time frame: 30 days after surgery
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lillian S Kao, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem and Cefazolin and Metronidazole. in people with Surgical Site Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lillian S Kao, MD ((713) 500-6280, Lillian.S.Kao@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that have post-laparotomy OS-SSIs (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.