Status:
COMPLETED
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the United States to treat chronic rhinosinusitis. Common practice is to prescribe prophylactic antibiotics postoperativ...
Eligibility Criteria
Inclusion
- \- 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
- Penicillin, cephalosporin, amoxicillin/clavulanate allergy
- Cystic Fibrosis
- Immunodeficiency
- Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery
- Odontogenic causes of sinusitis
- Fungal ball
- Infected mucocele
- Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess)
- Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)
- Age \<18
- Pregnant women
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT01919411
Start Date
February 1 2013
End Date
September 1 2018
Last Update
February 25 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114