Antibiotic Use in Facial Fracture Post Injury

Trauma Injury Clinical Trial

Official title:

Antibiotic Use in Facial Fracture Post Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925531
• Other study ID #: 042.TRA.2016.D
• Status: Recruiting
• Start date: July 29, 2016
• Est. completion date: July 23, 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: CrysteeCooper[@]mhd.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 23, 2024
• Est. primary completion date: July 23, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patient's = 18 years of age.

• Blunt and penetration injury.

Exclusion Criteria:

• Pregnant and breast feeding women.

Related Conditions & MeSH terms

• Trauma Injury
• Wounds and Injuries

Intervention

Drug:
• Antibiotics
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.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days post trauma
Secondary	Demographics	Age, sex, ethnicity	through study completion, an average of 2 years