Antibiotic Prophylaxis in Rhinoplasty

Study Overview
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Brief Summary
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This study compares the efficacy of a single intra-operative (intravenous) dose of cephalexin (first generation cephalosporin) or clindamycin (lincosamides), alone versus both intra-operative (intravenous) dose of cephalexin (first generation cephalosporin) or clindamycin (lincosamides) and postoperative oral dose of cephalexin or clindamycin use in nasal surgery.

Detailed Description
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The study will consist of 2 treatment arms: Treatment arm A: Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg. Treatment arm B: Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg and postoperative oral dose of cephalexin 250mg every 4 hours or clindamycin 150mg every 6 hours, for a duration of three days.

Official Title
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Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics

Conditions
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Nasal Obstruction, Nasal Surgical Procedures

Intervention / Treatment
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* Drug: Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg.
* Drug: Intra-operative single dose (iv) of cephalexin 2 g or clindamycin 900 mg and postoperative oral dose of cephalexin 250mg (every 4 hours) or clindamycin 150mg(every 6 hours) for 3 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (aged 18years and older) Exclusion Criteria: Prior rhinoplasty Any exogenous (non-nasal) grafts/implants Immune deficiency (DM, meds, other) History of radiotherapy to nose

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Applicable Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm A<br>Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg. | Drug: Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg.<br>* Treatment Arm A<br>* Other names: cleocin (clindamycin);|
| Active Comparator: Treatment arm B<br>Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg and postoperative oral dose of cephalexin 250mg every 4 hours or clindamycin 150mg every 6 hours, for a duration of three days. | Drug: Intra-operative single dose (iv) of cephalexin 2 g or clindamycin 900 mg and postoperative oral dose of cephalexin 250mg (every 4 hours) or clindamycin 150mg(every 6 hours) for 3 days<br>* Treatment Arm B<br>* Other names: cleocin (clindamycin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Infection Rate | Postoperatively, infection rates between treatment arms will be compared | Seven days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinoplasty, Antibiotic prophylaxis