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

NCT01919411 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-02-25

Study results available
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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.

Conditions

  • Sinusitis

Interventions

DRUG

Amoxicillin-Potassium Clavulanate

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

DRUG

Placebo

Patients in this arm will receive 7 days of placebo after surgery.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Eric H Holbrook, MD · MEEI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01919411 on ClinicalTrials.gov