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Sinusitis | Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial

Sinusitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy is defined as a course of broad spectrum or culture-directed antibiotics used in conjunction with a nasal steroid. Exclusion Criteria: 1. Penicillin, cephalosporin, amoxicillin/clavulanate allergy 2. Cystic Fibrosis 3. Immunodeficiency 4. Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery 5. Odontogenic causes of sinusitis 6. Fungal ball 7. Infected mucocele 8. Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess) 9. Non endoscopic sinus surgery (Caldwell luc, external approaches, etc) 10. Age <18 11. Pregnant women

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sinusitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Amoxicillin-Potassium ClavulanatePatients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.

Drug:PlaceboPatients in this arm will receive 7 days of placebo after surgery.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Amoxicillin-Potassium ClavulanateAll patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.

PlaceboAll patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.

Study Status

Recruiting

Start Date: February 2013

Completed Date: March 31, 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Sinonasal outcome test - 22

Secondary Outcome: Lund Kennedy Endoscopic Score

Study sponsors, principal investigator, and references

Principal Investigator: Eric H Holbrook, MD

Lead Sponsor: Massachusetts Eye and Ear Infirmary

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01919411

Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

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