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CompletedNCT04925531Updated Jun 10, 2026

Antibiotic Use in Facial Fracture Post Injury

An observational study in Trauma Injury, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
143
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Trauma Injury

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03

In context

Accidental Injuries

51 studies on the registry are indexed under Accidental Injuries; 28 are open to participants now.

This study's enrollment of 143 is below the median of 250 across 21 observational studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

trauma patients who were admitted to MHS between January1st 2010 and December 31st 2015

Inclusion criteria

  • Male and female patient's ≥ 18 years of age.
  • Blunt and penetration injury.

Exclusion criteria

Exclusion Criteria:

  • Pregnant and breast feeding women.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
143 participants (actual)
Target follow-up
5 Days
Patient registry
Yes

Groups and cohorts

  • 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

    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

    Drug: Antibiotics

Interventions

  • DrugAntibiotics

    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.

    Also known as: Ampicillin, Ancef, Erythro

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 days post trauma

Secondary outcomes

  1. Demographics

    Age, sex, ethnicity

    Time frame: through study completion, an average of 2 years

07

Study locations

1 site
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04925531
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Jul 29, 2016
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Last update
Jun 10, 2026

Study contacts

Michael Truitt, M.D.
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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