The Evaluation of Postoperative Antibiotics in Non-Infected Mandible

Status Recruiting

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04198129
Study type	Interventional
Source	The University of Texas Health Science Center, Houston
Contact	Nagi Demian, DDS/MD
Phone	713-500-5082
Email	Nagi.Demian@uth.tmc.edu
Status	Recruiting
Phase	Phase 1
Start date	October 1, 2020
Completion date	March 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04529421` - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting	`NCT04081792` - Optimal Antibiotics for Operated Diabetic Foot Infections	N/A
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation	`NCT05052203` - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting	`NCT00342589` - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed	`NCT03295825` - Heparin Binding Protein in Early Sepsis Diagnosis	N/A
Completed	`NCT03296423` - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly	Phase 4
Withdrawn	`NCT04217252` - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection	N/A
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Recruiting	`NCT02905552` - Myelodysplasic Syndromes and Risk Factors for Infection	N/A
Withdrawn	`NCT02904434` - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting	`NCT02768454` - Antimicrobials Stewardship by Pharmacist	N/A
Completed	`NCT02219776` - Decreasing Infection In Arthroscopic Shoulder Surgery	N/A
Completed	`NCT02210169` - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates	N/A
Recruiting	`NCT02098226` - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts	N/A
Completed	`NCT01846832` - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection	Phase 3
Terminated	`NCT01441206` - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants	Phase 1
Completed	`NCT01434797` - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Completed	`NCT01159834` - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms