Antibiotic Use in Facial Fracture Post Injury

NCT04925531 | Recruiting

• 1 other identifier: 042.TRA.2016.D
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Trauma Injury

Outcome Measures

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.

  3 days post trauma

Secondary Outcomes (1)

• Demographics

  through study completion, an average of 2 years

Study Arms (2)

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

Antibiotics DRUG

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

Antibiotic use for 5 days; Antibiotic use for <3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pregnant and breast feeding women.

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Accidental Injuries

Interventions

Anti-Bacterial Agents; Ampicillin; Cefazolin; Erythromycin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; Thiazines; Macrolides; Polyketides; Lactones

Study Officials

• Michael Truitt, M.D.

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

214-947-1280; CrysteeCooper@mhd.com

Ashley Haider

CONTACT

214 947 1280; ClinicalResearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: June 14, 2021
• Study Start: July 29, 2016
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)