The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

Infection Clinical Trial

Official title:

The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198129
• Other study ID #: HSC-MS-18-0640
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: Nagi Demian, DDS/MD
• Phone: 713-500-5082
• Email: Nagi.Demian[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Infection
• Jaw Fractures
• Mandibular Fractures

Intervention

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)
• 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:
• 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

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas
United States	Th University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of infection as measured by presence of persistent swelling,		post treatment week1
Primary	Evidence of infection as measured by presence of persistent swelling,		post treatment week 3
Primary	Evidence of infection as measured by presence of persistent swelling,		post treatment week 6-8
Primary	Evidence of infection as measured by presence of fever		post treatment week 1
Primary	Evidence of infection as measured by presence of fever		post treatment week 3
Primary	Evidence of infection as measured by presence of fever		post treatment week 6-8
Primary	Evidence of infection as measured by presence of recurrent swelling		post treatment week 1
Primary	Evidence of infection as measured by presence of recurrent swelling		post treatment week 3
Primary	Evidence of infection as measured by presence of recurrent swelling		post treatment week 6-8
Primary	Evidence of infection as measured by presence of erythema		post treatment week 1
Primary	Evidence of infection as measured by presence of erythema		post treatment week 3
Primary	Evidence of infection as measured by presence of erythema		post treatment week 6-8
Primary	Evidence of infection as measured by presence of purulent discharge		post treatment week 1
Primary	Evidence of infection as measured by presence of purulent discharge		post treatment week 3
Primary	Evidence of infection as measured by presence of purulent discharge		post treatment week 6-8
Secondary	No evidence of infection as measured by absence of persistent swelling		post treatment week 1
Secondary	No evidence of infection as measured by absence of persistent swelling		post treatment week 3
Secondary	No evidence of infection as measured by absence of persistent swelling		post treatment week 6-8
Secondary	No evidence of infection as measured by absence of fever		post treatment week 1
Secondary	No evidence of infection as measured by absence of fever		post treatment week 3
Secondary	No evidence of infection as measured by absence of fever		post treatment week 6-8
Secondary	No evidence of infection as measured by absence of recurrent swelling		post treatment week 1
Secondary	No evidence of infection as measured by absence of recurrent swelling		post treatment week 3
Secondary	No evidence of infection as measured by absence of recurrent swelling		post treatment week 6-8
Secondary	No evidence of infection as measured by absence of erythema		post treatment week 1
Secondary	No evidence of infection as measured by absence of erythema		post treatment week 3
Secondary	No evidence of infection as measured by absence of erythema		post treatment week 6-8
Secondary	No evidence of infection as measured by absence of purulent discharge		post treatment week 1
Secondary	No evidence of infection as measured by absence of purulent discharge		post treatment week 3
Secondary	No evidence of infection as measured by absence of purulent discharge		post treatment week 6-8