The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems

Study Overview

• Status: Unknown
• Conditions: Infection; Jaw Fractures
• Intervention / Treatment: Drug: Antibiotic treatment (Unasyn or Cleocin); Drug: Antibiotic treatment (Augmentin or Cleocin); Other: Control Group

Detailed Description

The purpose of this study is to evaluate the use of antibiotics postoperatively in non-infected mandible fractures compared to the lack of postoperative antibiotics in the same population.

The first outcome measure is infection. Evidence of infection includes persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.

The second outcome measure is no infection. Absence of persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.

Outcome measures will be assessed on follow-up visits: post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks. If the subject presents with any of the above mentioned symptoms during the 8 week post-op period, the subject will be considered positive for infection.

Prospective randomized trial: Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care. Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.

The patient will follow up post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks.

Patients will be monitored for any complications, including reaction to IV and oral antibiotics. Patient will assessed after the one-time post-op IV antibiotic dose and during their follow-up visits at weeks 1, 3, and 6-8.

• Study Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nagi Demian, DDS/MD; Phone Number: 713-500-5082; Email: Nagi.Demian@uth.tmc.edu
• Study Contact Backup: Name: Donna Martinez; Phone Number: 713-500-5082; Email: Donna.M.Martinez@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77030
      • Recruiting
      • Th University of Texas Health Science Center at Houston
      • Contact: Nagi Demian, DDS, MD; Phone Number: 713-500-5082; Email: Nagi.Demian@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)

Exclusion Criteria:

• Age - < 18 years
• Pregnancy
• Fracture Site - closed / non-dentate eg. Condylar neck, edentulous
• Soft Tissue Injury - > Grade 4 (GSW)
• Allergic to all study drugs

• Medical Problems

  1. Diabetes - Hb A1C > 10
  2. Immunologic compromise
  3. On Chemotherapy
• Interval - Injury to Surgery - > 10days

• Already receiving antibiotics for

  1. Another wound eg. Open fracture prophylaxis
  2. Documented / suspected infection
• Inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.	Drug: Antibiotic treatment (Unasyn or Cleocin); Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies); Other Names: UNasyn is the trade name and the genric name is Ampicillin and Sub lactam. Cleocin is a trade name and the generic name is clindamycin.; Drug: Antibiotic treatment (Augmentin or Cleocin); the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days, or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies).; Other Names: Augmentin is the trade name and the generic is Amoxicillin Clavulinate or clavulinic acid. Cleocin is the trade name and the generic is clindamycin.
Active Comparator: Control; Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care.	Other: Control Group; Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of infection as measured by presence of persistent swelling,	post treatment week1
Evidence of infection as measured by presence of persistent swelling,	post treatment week 3
Evidence of infection as measured by presence of persistent swelling,	post treatment week 6-8
Evidence of infection as measured by presence of fever	post treatment week 1
Evidence of infection as measured by presence of fever	post treatment week 3
Evidence of infection as measured by presence of fever	post treatment week 6-8
Evidence of infection as measured by presence of recurrent swelling	post treatment week 1
Evidence of infection as measured by presence of recurrent swelling	post treatment week 3
Evidence of infection as measured by presence of recurrent swelling	post treatment week 6-8
Evidence of infection as measured by presence of erythema	post treatment week 1
Evidence of infection as measured by presence of erythema	post treatment week 3
Evidence of infection as measured by presence of erythema	post treatment week 6-8
Evidence of infection as measured by presence of purulent discharge	post treatment week 1
Evidence of infection as measured by presence of purulent discharge	post treatment week 3
Evidence of infection as measured by presence of purulent discharge	post treatment week 6-8

Secondary Outcome Measures

Outcome Measure	Time Frame
No evidence of infection as measured by absence of persistent swelling	post treatment week 1
No evidence of infection as measured by absence of persistent swelling	post treatment week 3
No evidence of infection as measured by absence of persistent swelling	post treatment week 6-8
No evidence of infection as measured by absence of fever	post treatment week 1
No evidence of infection as measured by absence of fever	post treatment week 3
No evidence of infection as measured by absence of fever	post treatment week 6-8
No evidence of infection as measured by absence of recurrent swelling	post treatment week 1
No evidence of infection as measured by absence of recurrent swelling	post treatment week 3
No evidence of infection as measured by absence of recurrent swelling	post treatment week 6-8
No evidence of infection as measured by absence of erythema	post treatment week 1
No evidence of infection as measured by absence of erythema	post treatment week 3
No evidence of infection as measured by absence of erythema	post treatment week 6-8
No evidence of infection as measured by absence of purulent discharge	post treatment week 1
No evidence of infection as measured by absence of purulent discharge	post treatment week 3
No evidence of infection as measured by absence of purulent discharge	post treatment week 6-8

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Nagi Demian, DDS/MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Infection; Jaw fracture
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures; Jaw Fractures; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protein Synthesis Inhibitors; Antitubercular Agents; beta-Lactamase Inhibitors; Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Sultamicillin
• Other Study ID Numbers: HSC-MS-18-0640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No