Use of Preoperative and Postoperative Antimicrobial Treatment

NCT04707092 | Unknown Phase 4

• 1 other identifier: 3486
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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

Conditions

Ear Infection Bacterial; Surgical Site Infection; Antibiotic Side Effect

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Side effects from treatment with antibiotics

  1 month

Secondary Outcomes (2)

• Infection of surgical site (immediate)

  1 month

• Infection of surgical site (long term)

  2 years

Study Arms (2)

Antibiotic at induction

EXPERIMENTAL

Patients will receive one single dose of Antibiotic at induction

Drug: Antibiotic

Antibiotic one week

EXPERIMENTAL

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

Drug: Antibiotic

Interventions

Antibiotic DRUG

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

Antibiotic at induction; Antibiotic one week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in the study
• Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Canada

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization in two treatment arms

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)