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). 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.

Study Overview

• Status: Recruiting
• Conditions: Trauma Injury
• Intervention / Treatment: Drug: Antibiotics

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ashley Haider; Phone Number: 214 947 1280; Email: ClinicalResearch@mhd.com
• Study Contact Backup: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: CrysteeCooper@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Brittany Reinhart, BS; Phone Number: 214-947-1772; Email: AnayoOhiri@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant and breast feeding women.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Ampicillin, Ancef, Erythro
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; 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.; Other Names: Ampicillin, Ancef, Erythro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Age, sex, ethnicity	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Michael Truitt, M.D., Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start: July 29, 2016
• Primary Completion (Estimated): July 23, 2024
• Study Completion (Estimated): July 23, 2024

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents; Ampicillin; Anti-Bacterial Agents
• Other Study ID Numbers: 042.TRA.2016.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No