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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic at induction | Experimental | Patients will receive one single dose of Antibiotic at induction |
|
| Antibiotic one week | Experimental | Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic | Drug | Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Side effects from treatment with antibiotics | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Center | Toronto | Canada |
The individual participant data will not be shared since no conclusions can be drawn from single patient data, the results will be made available in detail
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Randomization in two treatment arms
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| 2 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |