Use of Preoperative and Postoperative Antimicrobial Treatment

Sunnybrook Health Sciences Centre

Status and phase

Unknown

Phase 4

Conditions

Antibiotic Side Effect

Surgical Site Infection

Ear Infection Bacterial

Treatments

Drug: Antibiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT04707092

3486

Details and patient eligibility

About

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

Full description

Patients will be asked to participate in the study.
Randomization
Surgery
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
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

Enrollment

304 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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