The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind clinical trial on the prophylactic use of antibiotics in postoperative endoscopic sinus vs placebo surgery. Patients with chronic rhinosinusitis with or without polyps who have consented to endoscopic sinus surgery according to Canadian practice guidelines may be included in the study after approval by the Research Ethics Board of the University Hospital Center. Quebec and signature of consent.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHU de Quebec-Universite Laval
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• 18 years old and over able to consent

• Patients with chronic rhinosinusitis and failure to maximal medical treatment

• Endoscopic sinus surgery with at least one of the following: maxillary antrostomy, ethmoidectomy, sphenoidotomy and / or frontal sinusotomy

Exclusion Criteria:

• Antibiotherapy less than 2 weeks before the intervention

• Penicillin allergy

• Inability to establish follow-up

• Open sinus surgery or associated septorhinoplasty (simple septoplasty is not considered an exclusion criterion)

• Immunodeficiency

• Cystic fibrosis of the pancreas

• Pregnancy

• odontogenic sinusitis

• Fungal sinusitis

• Diabetic

• Ciliary dyskinesia

• Sinus neoplasia

• Patient requiring antibiotic prophylaxis for endocarditis