Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01919411 · ClinicalTrials.gov registry record · Phase 4
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
A Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- Phase 4
- Development phase
- 134
- Enrollment target
NCT01919411: Completed Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01919411 is a Phase 4 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 134 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01919411, a Phase 4 study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms.
Interventions
- DRUG Placebo
- DRUG Amoxicillin-Potassium Clavulanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2013-02 |
| Est. Completion | 2018-09 |
| Phase | Phase 4 |
What the finished NCT01919411 record still lists
NCT01919411 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01919411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01919411 about?
NCT01919411 is a clinical study titled "Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial". 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 anti...
What is the current status of trial NCT01919411?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 134 participants. The study started on 2013-02. Estimated completion is 2018-09.
What interventions are being tested in trial NCT01919411?
The interventions under investigation include: Placebo (DRUG), Amoxicillin-Potassium Clavulanate (DRUG).
Who is sponsoring clinical trial NCT01919411?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01919411's enrollment target sits among peer trials
134 606th of 2000 higher than 1,391 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02469662 · 134 participants · NA
Clinical Outcomes Study of the Nexel Total Elbow
- NCT03110822 · 134 participants · Phase 1
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
- NCT04678648 · 134 participants · Phase 1
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
- NCT05264857 · 134 participants · NA
Decision Aid and Thyroid Nodules Management
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia