Infection, Jaw Fractures
Conditions
Keywords
Infection, Jaw fracture
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.
Interventions
DRUGAntibiotic treatment (Unasyn or Cleocin)
Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)
DRUGAntibiotic 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).
OTHERControl Group
Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of infection as measured by presence of fever | post treatment week 1 |
| Evidence of infection as measured by presence of recurrent swelling | post treatment week 1 |
| Evidence of infection as measured by presence of erythema | post treatment week 1 |
| Evidence of infection as measured by presence of purulent discharge | post treatment week 1 |
| Evidence of infection as measured by presence of persistent swelling, | post treatment week1 |
Secondary
| 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 fever | post treatment week 1 |
| No evidence of infection as measured by absence of recurrent swelling | post treatment week 1 |
| No evidence of infection as measured by absence of erythema | post treatment week 1 |
| No evidence of infection as measured by absence of purulent discharge | post treatment week 1 |
Countries
United States
Outcome results
None listed