Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery

• Status: Unknown status
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

1. Adult patient (18 years of age or older) that requires a unilateral or bilateral sinus augmentation surgery.

2. Weight <150 kg.

Exclusion Criteria:

1. Need for prophylactic antibiotics for infective endocarditis.

2. Chronic antibiotics therapy.

3. Special populations: pregnant women, minors and legally incompetent patients.

4. Patients receiving anticoagulants.

5. Non-balanced diabetes mellitus.

6. Immune-suppression: corticosteroids treatment equivalent to 15mg prednisone for at least 14 days in the past month; chemotherapy, TNF inhibitor or drugs that suppress T-cell activity during the past 90 days; HIV infection.

7. Pathology of the maxillary sinus.

8. History of chronic sinusitis.

9. Patients that underwent a Caldwell-Luc procedure.

10. Patients with residual teeth roots at the planned surgical site.

11. A known state of carriage of Methicillin resistant Staphylococcus aureus or Clostridium difficile in the past year.