Use of Preoperative and Postoperative Antimicrobial Treatment

Sunnybrook Health Sciences Centre304 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

304

Conditions

Ear Infection Bacterial Surgical Site Infection Antibiotic Side Effect

Interventions

AntibioticDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sunnybrook Health Sciences Center

Toronto, Canada

Outcomes

Primary Outcomes

Adverse events

Side effects from treatment with antibiotics

Time frame: 1 month

Secondary Outcomes

Infection of surgical site (immediate)

Infection of surgical site with discharge, redness, fever

Time frame: 1 month

Infection of surgical site (long term)

infection of surgical site with discharge, fever, extrusion of device

Time frame: 2 years

Data from ClinicalTrials.gov

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