Use of Preoperative and Postoperative Antimicrobial Treatment
NCT ID: NCT04707092
Last Updated: 2021-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
304 participants
INTERVENTIONAL
2021-06-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Antibiotics Use During Surgery Help to Decrease Wound Infection and Increase Success After Ear Surgery in Children
NCT03700814
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada
NCT07189858
Surgical Site Infection and Antibiotic Use Study
NCT04631185
The Role of Guideline-adherent Perioperative Antibiotic Administration and the Risk of Surgical Site Infections After Non-cardiac Surgery.
NCT03982810
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
NCT02600559
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Antibiotic at induction
Patients will receive one single dose of Antibiotic at induction
Antibiotic
Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
Antibiotic one week
Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic
Antibiotic
Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Antibiotic
Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sunnybrook Health Sciences Center
Toronto, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3486
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.