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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Antibiotics

Study Locations (1)

Texas

  • Methodist Dallas Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2016-07-29
Est. Completion 2024-07-23

Sponsor

Methodist Health System

125 total trials

What the Registry Record Tells You About NCT04925531

The ClinicalTrials.gov registry entry for NCT04925531 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 434-participant average among 15 other Trauma Injury trials with a reported enrollment target (130% higher). The listed sponsor is Methodist Health System, which has 125 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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