Trauma InjuryNCT04925531
Antibiotic Use in Facial Fracture Post Injury
An observational study of Trauma Injury, run by Methodist Health System at 1 site in United States.
Trial summary
Facial fractures make up a significant proportion of injuries in trauma patients (1, 2). Approximately 3 million individuals suffer craniofacial trauma in the United States on a yearly basis, and approximately 50% of all wounds presenting to emergency rooms involve the head and neck (1, 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Antibiotics
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2016to 12 Jun 2025
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: trauma patients who were admitted to MHS between January1st 2010 and December 31st 2015
Who may be able to join
- Male and female patient's ≥ 18 years of age.
- Blunt and penetration injury.
Who cannot join
- Pregnant and breast feeding women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Facial fractures make up a significant proportion of injuries in trauma patients (1, 2). Approximately 3 million individuals suffer craniofacial trauma in the United States on a yearly basis, and approximately 50% of all wounds presenting to emergency rooms involve the head and neck (1, 2). Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today (3). Previous research work showed that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42.2% to 8.9% (4). However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot up to duration of 7 and even ten days postoperatively. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance (5). In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of a postoperative infection. Up to date there is no standard to support the duration of antibiotic administration after surgical repair of a facial fracture. In this proposal, Investigators are aiming to investigate if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.
Read the detailed description
This proposed research is a retrospective chart review to examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.
Records of trauma patients who were admitted to Methodist Health System (MHS) between January1st 2010 and December 31st 2015 will be retrieved to review the clinical charts according to our inclusion and exclusion criteria.
Patients will be segregated in to two groups according to the duration of antibiotic use, group 1 (less than 3days) and group 2 (5 days).
Basic demographics and clinical outcomes parameters as noted above will be attained from the patient's medical records.
- Conditions
- Trauma Injury
- Being tested
- Antibiotics
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Also called Ampicillin, Ancef, Erythro
to examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures in trauma patients.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic use for <3 days | a retrospective chart review to examine if either the utility of antibiotics administered for 3 days make a difference in the clinical outcomes after facial fractures Receives: Drug: Antibiotics | |
| Antibiotic use for 5 days | a retrospective chart review to examine if either the utility of antibiotics administered for 5 days make a difference in the clinical outcomes after facial fractures Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury associated infectious complications within 30-days of injury
This will help to determine if specific intervals of prophylactic antibiotic use for facial fracture patients decreases the incidence of fracture-associated infections.
Measured: 3 days post trauma
Secondary outcomes (1)
Demographics
Age, sex, ethnicity
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start29 Jul 2016
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 143 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Truitt, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925531
- Sponsor's protocol ID
- 042.TRA.2016.D
- Status last verified
- Jun 2025
- First submitted
- 12 Aug 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Use in Facial Fracture Post Injury
- ClinicalTrials.gov ID
- NCT04925531
- Acronym / sponsor ID
- 042.TRA.2016.D
- Conditions
- Trauma Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 29 Jul 2016
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 14 Jun 2021 (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.
Facial fractures make up a significant proportion of injuries in trauma patients (1, 2). Approximately 3 million individuals suffer craniofacial trauma in the United States on a yearly basis, and approximately 50% of all wounds presenting to emergency rooms involve the head and neck (1, 2). Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today (3). Previous research work showed that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42.2% to 8.9% (4). However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot up to duration of 7 and even ten days postoperatively. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance (5). In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of a postoperative infection. Up to date there is no standard to support the duration of antibiotic administration after surgical repair of a facial fracture. In this proposal, Investigators are aiming to investigate if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.
Detailed description
This proposed research is a retrospective chart review to examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.
Records of trauma patients who were admitted to Methodist Health System (MHS) between January1st 2010 and December 31st 2015 will be retrieved to review the clinical charts according to our inclusion and exclusion criteria.
Patients will be segregated in to two groups according to the duration of antibiotic use, group 1 (less than 3days) and group 2 (5 days).
Basic demographics and clinical outcomes parameters as noted above will be attained from the patient's medical records.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic use for <3 days | – | Drug: Antibioticsa retrospective chart review to examine if either the utility of antibiotics administered for 3 days make a difference in the clinical outcomes after facial fractures |
| Antibiotic use for 5 days | – | Drug: Antibioticsa retrospective chart review to examine if either the utility of antibiotics administered for 5 days make a difference in the clinical outcomes after facial fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- trauma patients who were admitted to MHS between January1st 2010 and December 31st 2015
Key inclusion criteria (2 listed)
- Male and female patient's ≥ 18 years of age.
- Blunt and penetration injury.
Key exclusion criteria (1 listed)
- Pregnant and breast feeding 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 |
|---|---|---|
| AntibioticsAlso: Ampicillin, Ancef, Erythroto examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures in trauma patients. | Drug | Antibiotic use for 5 days, Antibiotic use for <3 days |
Primary outcome
Injury associated infectious complications within 30-days of injury
Time frame: 3 days post trauma
This will help to determine if specific intervals of prophylactic antibiotic use for facial fracture patients decreases the incidence of fracture-associated infections.
1 secondary outcome
Demographics
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Michael Truitt, M.D. principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Methodist Health System 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jun 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury associated infectious complications within 30-days of injury (time frame: 3 days post trauma). 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 10 Jun 2026.