Study Stopped
Recruitment issues
The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
1 other identifier
interventional
13
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedJune 26, 2025
February 1, 2024
1.3 years
December 9, 2019
June 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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 Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALTrial 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.
Control
ACTIVE COMPARATORControl group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care.
Interventions
Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)
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).
Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care
Eligibility Criteria
You may qualify if:
- All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)
You may not qualify if:
- 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
- Diabetes - Hb A1C \> 10
- Immunologic compromise
- On Chemotherapy
- Interval - Injury to Surgery - \> 10days
- Already receiving antibiotics for
- Another wound eg. Open fracture prophylaxis
- Documented / suspected infection
- Inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Th University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nagi Demian, DDS/MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 13, 2019
Study Start
October 1, 2020
Primary Completion
January 20, 2022
Study Completion
March 20, 2022
Last Updated
June 26, 2025
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share