NCT04707092

Use of Preoperative and Postoperative Antimicrobial Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups. One group will receive a single treatment with an antibiotic at induction The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic

Detailed description

1. Patients will be asked to participate in the study. 2. Randomization 3. Surgery 4. Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation 5. Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections

Conditions

• Ear Infection Bacterial
• Surgical Site Infection
• Antibiotic Side Effect

Interventions

Type	Name	Description
DRUG	Antibiotic	Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2021-01-13
• Last updated: 2021-10-04

Locations

1 site across 1 country: Canada