Use of Preoperative and Postoperative Antimicrobial Treatment

Phase 4

• Conditions: Surgical Site Infection; Antibiotic Side Effect; Ear Infection Bacterial
• Interventions: Drug: Antibiotic

• Registration Number: NCT04707092
• Lead Sponsor: Sunnybrook Health Sciences Centre

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

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic one week	Antibiotic	Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic
Antibiotic at induction	Antibiotic	Patients will receive one single dose of Antibiotic at induction

Primary Outcome Measures

Name	Time	Method
Adverse events	1 month	Side effects from treatment with antibiotics

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Canada