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NCT04707092 Clinical Trial

Use of Preoperative and Postoperative Antimicrobial Treatment

Surgical Site Infection Clinical Trial

Official title:
Use of Preoperative and Postoperative Antimicrobial Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04707092
Other study ID # 3486
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2022

Study information
Verified date October 2021
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 304
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Sunnybrook Health Sciences Center Toronto

Sponsors (1)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Side effects from treatment with antibiotics 1 month
Secondary Infection of surgical site (immediate) Infection of surgical site with discharge, redness, fever 1 month
Secondary Infection of surgical site (long term) infection of surgical site with discharge, fever, extrusion of device 2 years
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