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
• Status: Enrolling by invitation
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Bacterial Infections
• Communicable Diseases
• Ear Infection Bacterial
• Infections
• Otitis
• Surgical Site Infection
• Surgical Wound Infection

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