The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

The University of Texas System (UT)

Status and phase: Terminated; Phase 1

Conditions: Infection; Jaw Fractures

Treatments: Other: Control Group; Drug: Antibiotic treatment (Augmentin or Cleocin); Drug: Antibiotic treatment (Unasyn or Cleocin)

Study type: Interventional

Funder types: Other

Identifiers

NCT04198129

HSC-MS-18-0640

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Drug: Antibiotic treatment (Unasyn or Cleocin)

Drug: Antibiotic treatment (Augmentin or Cleocin)

Control

Active Comparator group

Description:

Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care.

Treatment:

Other: Control Group