Antibiotic Use in Facial Fracture Post Injury

NCT ID: NCT04925531

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2024-07-23

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.

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.

Conditions

Trauma Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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

Antibiotics

Intervention Type: 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.

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

Antibiotics

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ampicillin, Ancef, Erythro

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant and breast feeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Truitt, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Crystee Cooper, DHEd

Role: CONTACT

CrysteeCooper@mhd.com

214-947-1280

Ashley Haider

Role: CONTACT

ClinicalResearch@mhd.com

214 947 1280

Facility Contacts

Brittany Reinhart, BS

Role: primary

AnayoOhiri@mhd.com

214-947-1772

Other Identifiers

042.TRA.2016.D

Identifier Type: -

Identifier Source: org_study_id