Clinical trial NCT04198129: The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
Official title: The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Jaw Fractures
Infection
Keywords: Infection
Jaw fracture
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of infection as measured by presence of persistent swelling,
timeFrame: post treatment week1
measure: Evidence of infection as measured by presence of persistent swelling,
timeFrame: post treatment week 3
measure: Evidence of infection as measured by presence of persistent swelling,
timeFrame: post treatment week 6-8
measure: Evidence of infection as measured by presence of fever
timeFrame: post treatment week 1
measure: Evidence of infection as measured by presence of fever
timeFrame: post treatment week 3
measure: Evidence of infection as measured by presence of fever
timeFrame: post treatment week 6-8
measure: Evidence of infection as measured by presence of recurrent swelling
timeFrame: post treatment week 1
measure: Evidence of infection as measured by presence of recurrent swelling
timeFrame: post treatment week 3
measure: Evidence of infection as measured by presence of recurrent swelling
timeFrame: post treatment week 6-8
measure: Evidence of infection as measured by presence of erythema
timeFrame: post treatment week 1
measure: Evidence of infection as measured by presence of erythema
timeFrame: post treatment week 3
measure: Evidence of infection as measured by presence of erythema
timeFrame: post treatment week 6-8
measure: Evidence of infection as measured by presence of purulent discharge
timeFrame: post treatment week 1
measure: Evidence of infection as measured by presence of purulent discharge
timeFrame: post treatment week 3
measure: Evidence of infection as measured by presence of purulent discharge
timeFrame: post treatment week 6-8
Secondary outcomes:
measure: No evidence of infection as measured by absence of persistent swelling
timeFrame: post treatment week 1
measure: No evidence of infection as measured by absence of persistent swelling
timeFrame: post treatment week 3
measure: No evidence of infection as measured by absence of persistent swelling
timeFrame: post treatment week 6-8
measure: No evidence of infection as measured by absence of fever
timeFrame: post treatment week 1
measure: No evidence of infection as measured by absence of fever
timeFrame: post treatment week 3
measure: No evidence of infection as measured by absence of fever
timeFrame: post treatment week 6-8
measure: No evidence of infection as measured by absence of recurrent swelling
timeFrame: post treatment week 1
measure: No evidence of infection as measured by absence of recurrent swelling
timeFrame: post treatment week 3
measure: No evidence of infection as measured by absence of recurrent swelling
timeFrame: post treatment week 6-8
measure: No evidence of infection as measured by absence of erythema
timeFrame: post treatment week 1
measure: No evidence of infection as measured by absence of erythema
timeFrame: post treatment week 3
measure: No evidence of infection as measured by absence of erythema
timeFrame: post treatment week 6-8
measure: No evidence of infection as measured by absence of purulent discharge
timeFrame: post treatment week 1
measure: No evidence of infection as measured by absence of purulent discharge
timeFrame: post treatment week 3
measure: No evidence of infection as measured by absence of purulent discharge
timeFrame: post treatment week 6-8
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Th University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nagi Demian, DDS/MD
role: PRINCIPAL_INVESTIGATOR
References: