At a glance
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Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Amoxicillin-Potassium Clavulanate and Placebo for Sinusitis. Completed, enrolled 134 participants across 1 site.
Detailed Summary
Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery. There is minimal data to support this. The investigators' study will aim to demonstrate that patients' quality of life and rate of post operative infection is the same whether they receive or do not receive antibiotics post operatively. The investigators hypothesis is that the disease specific quality of life of patients taking post-operative antibiotics is not inferior to the quality of life of patients who do not take post-operative antibiotics, and the rate of post-operative infections are the same. The investigators' specific aim is to compare validated symptom scores between post-operative populations who are given or are not given antibiotics. Rates of infections in the first 10 days after surgery will be recorded. The investigators will also compare endoscopic grades of sinus cavities during the post-operative follow up exams as an additional outcome measure.
Study Details
Timeline
Interventions
Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.
Patients in this arm will receive 7 days of placebo after surgery.