The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

NCT ID: NCT04198129

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-03-20

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.

Conditions

Jaw Fractures; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Antibiotic treatment (Unasyn or Cleocin)

Intervention Type: DRUG

Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)

Antibiotic treatment (Augmentin or Cleocin)

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

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

Interventions

Antibiotic treatment (Unasyn or Cleocin)

Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)

Intervention Type: 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).

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention 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.; Augmentin is the trade name and the generic is Amoxicillin Clavulinate or clavulinic acid. Cleocin is the trade name and the generic is clindamycin.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Nagi Demian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagi Demian, DDS/MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann Hospital

Houston, Texas, United States

Th University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-18-0640

Identifier Type: -

Identifier Source: org_study_id