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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 is a Phase 4 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 134 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01919411
The ClinicalTrials.gov registry entry for NCT01919411 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01919411 reports 0 study locations.
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.
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