Back to resultsUse of Preoperative and Postoperative Antimicrobial Treatment
Primary Purpose
Ear Infection Bacterial, Surgical Site Infection, Antibiotic Side Effect
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Antibiotic
Sponsored by
About this trial
This is an interventional other trial for Ear Infection Bacterial
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Antibiotic at induction
Antibiotic one week
Arm Description
Patients will receive one single dose of Antibiotic at induction
Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic
Outcomes
Primary Outcome Measures
Adverse events
Side effects from treatment with antibiotics
Secondary Outcome Measures
Infection of surgical site (immediate)
Infection of surgical site with discharge, redness, fever
Infection of surgical site (long term)
infection of surgical site with discharge, fever, extrusion of device
Full Information
NCT ID
NCT04707092
First Posted
January 11, 2021
Last Updated
October 1, 2021
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04707092
Brief Title
Use of Preoperative and Postoperative Antimicrobial Treatment
Official Title
Use of Preoperative and Postoperative Antimicrobial Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Infection Bacterial, Surgical Site Infection, Antibiotic Side Effect
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomization in two treatment arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic at induction
Arm Type
Experimental
Arm Description
Patients will receive one single dose of Antibiotic at induction
Arm Title
Antibiotic one week
Arm Type
Experimental
Arm Description
Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
Primary Outcome Measure Information:
Title
Adverse events
Description
Side effects from treatment with antibiotics
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Infection of surgical site (immediate)
Description
Infection of surgical site with discharge, redness, fever
Time Frame
1 month
Title
Infection of surgical site (long term)
Description
infection of surgical site with discharge, fever, extrusion of device
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data will not be shared since no conclusions can be drawn from single patient data, the results will be made available in detail
Learn more about this trial
Use of Preoperative and Postoperative Antimicrobial Treatment
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