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NCT04925531 · ClinicalTrials.gov registry record
Antibiotic Use in Facial Fracture Post Injury
A clinical trial of Trauma Injury, sponsored by Methodist Health System.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT04925531: Recruiting study of Trauma Injury, sponsored by Methodist Health System.
NCT04925531 is a study of Trauma Injury that is actively recruiting participants, run by Methodist Health System. The registered enrollment target is 1,000 participants, above the 434-participant average among 15 other Trauma Injury trials with a reported enrollment target (130% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925531, a study of Trauma Injury, is actively recruiting participants, sponsored by Methodist Health System.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
This will help to determine if specific intervals of prophylactic antibiotic use for facial fracture patients decreases the incidence of fracture-associated infections.
Conditions Studied
Interventions
- DRUG Antibiotics
Study Locations (1)
Texas
- Methodist Dallas Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2016-07-29 |
| Est. Completion | 2024-07-23 |
What NCT04925531 shows while recruiting
NCT04925531 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 434-participant average among 15 other Trauma Injury trials with a reported enrollment target (130% higher).
The record links to 1 condition, with Trauma Injury appearing as the primary indexed condition, and to 1 intervention - of which Antibiotics is the first listed.
NCT04925531 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04925531 about?
NCT04925531 is a clinical study titled "Antibiotic Use in Facial Fracture Post Injury". 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). Treatmen...
What is the current status of trial NCT04925531?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2016-07-29. Estimated completion is 2024-07-23.
What conditions does trial NCT04925531 study?
This clinical trial studies the following conditions: Trauma Injury.
What interventions are being tested in trial NCT04925531?
The interventions under investigation include: Antibiotics (DRUG).
Who is sponsoring clinical trial NCT04925531?
This trial is sponsored by Methodist Health System, which has 125 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04925531 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Trauma Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04925531's enrollment target sits among peer trials
1,000 3rd of 15 higher than 12 of 15 other Trauma Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Trauma Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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