Antibiotic Side Effect, Ear Infection Bacterial, Surgical Site Infection
Conditions
Brief 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
Interventions
DRUGAntibiotic
Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomization in two treatment arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to participate in the study * Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)
Exclusion criteria
* multiple allergies to antibiotic substances * therapy with an antibiotic substance within the last 6 weeks * prior radiation to the head and neck patients undergoing revision surgery * Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 month | Side effects from treatment with antibiotics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection of surgical site (immediate) | 1 month | Infection of surgical site with discharge, redness, fever |
| Infection of surgical site (long term) | 2 years | infection of surgical site with discharge, fever, extrusion of device |
Countries
Canada
Outcome results
None listed