Use of Preoperative and Postoperative Antimicrobial Treatment

Study Overview
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Brief Summary
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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

Detailed Description
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Patients will be asked to participate in the study. Randomization Surgery 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 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

Official Title
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Use of Preoperative and Postoperative Antimicrobial Treatment

Conditions
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Ear Infection Bacterial, Surgical Site Infection, Antibiotic Side Effect

Intervention / Treatment
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* Drug: Antibiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization in two treatment arms
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Side effects from treatment with antibiotics | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection of surgical site (immediate) | Infection of surgical site with discharge, redness, fever | 1 month | 
| Infection of surgical site (long term) | infection of surgical site with discharge, fever, extrusion of device | 2 years |