Use of Preoperative and Postoperative Antimicrobial Treatment

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04707092
• Collaborator: (none)
• Enrollment: 304
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 16

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ear Infection Bacterial; Surgical Site Infection; Antibiotic Side Effect	Drug: Antibiotic	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomization in two treatment armsRandomization in two treatment arms
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Use of Preoperative and Postoperative Antimicrobial Treatment
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antibiotic at induction Patients will receive one single dose of Antibiotic at induction	Drug: Antibiotic; Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
Experimental: Antibiotic one week Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic	Drug: Antibiotic; Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week

Outcome Measures

Primary Outcome Measures

1. Adverse events [1 month]

   Side effects from treatment with antibiotics

Secondary Outcome Measures

1. Infection of surgical site (immediate) [1 month]

   Infection of surgical site with discharge, redness, fever

2. Infection of surgical site (long term) [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Center	Toronto		Canada

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT04707092
• Other Study ID Numbers: 3486
• First Posted: Jan 13, 2021
• Last Update Posted: Oct 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Bacterial Infections; Otitis; Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 4, 2021