The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT04198129

Collaborator

(none)

174

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Jaw Fractures Infection	Drug: Antibiotic treatment (Unasyn or Cleocin) Drug: Antibiotic treatment (Augmentin or Cleocin) Other: Control Group	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Antibiotic treatment (Unasyn or Cleocin) Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies) Other 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. 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). Other Names: Augmentin is the trade name and the generic is Amoxicillin Clavulinate or clavulinic acid. Cleocin is the trade name and the generic is clindamycin.
Active Comparator: Control Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care.	Other: 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

Arm

Intervention/Treatment

Experimental: 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.

Drug: Antibiotic treatment (Unasyn or Cleocin)

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

Other 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.

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).

Other Names:

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

Active Comparator: Control

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

Other: 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
No evidence of infection as measured by absence of fever [post treatment week 6-8]
No evidence of infection as measured by absence of recurrent swelling [post treatment week 1]
No evidence of infection as measured by absence of recurrent swelling [post treatment week 3]
No evidence of infection as measured by absence of recurrent swelling [post treatment week 6-8]
No evidence of infection as measured by absence of erythema [post treatment week 1]
No evidence of infection as measured by absence of erythema [post treatment week 3]
No evidence of infection as measured by absence of erythema [post treatment week 6-8]
No evidence of infection as measured by absence of purulent discharge [post treatment week 1]
No evidence of infection as measured by absence of purulent discharge [post treatment week 3]
No evidence of infection as measured by absence of purulent discharge [post treatment week 6-8]