- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919411
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy is defined as a course of broad spectrum or culture-directed antibiotics used in conjunction with a nasal steroid.
Exclusion Criteria:
- Penicillin, cephalosporin, amoxicillin/clavulanate allergy
- Cystic Fibrosis
- Immunodeficiency
- Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery
- Odontogenic causes of sinusitis
- Fungal ball
- Infected mucocele
- Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess)
- Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)
- Age <18
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amoxicillin-Potassium Clavulanate
All patients in the study will undergo endoscopic sinus surgery.
This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
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Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.
Other Names:
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Placebo Comparator: Placebo
All patients in the study will undergo endoscopic sinus surgery.
This arm will receive 7 days of placebo orally twice a day after surgery.
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Patients in this arm will receive 7 days of placebo after surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sinonasal Outcome Test - 22
Time Frame: One week post operatively
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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. |
One week post operatively
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Sinonasal Outcome Test - 22
Time Frame: Six weeks post operatively
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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. |
Six weeks post operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lund Kennedy Endoscopic Score
Time Frame: One week postoperatively
|
The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. |
One week postoperatively
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Lund Kennedy Endoscopic Score
Time Frame: Six weeks postoperatively
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The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. |
Six weeks postoperatively
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Post Operative Infection
Time Frame: One week postoperatively
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The investigators will record the rate of post operative infections in the two groups.
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One week postoperatively
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Number of Participants With Post Operative Infection
Time Frame: Six weeks postoperatively
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The investigators will record the rate of post operative infections in the two groups.
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Six weeks postoperatively
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Collaborators and Investigators
Investigators
- Principal Investigator: Eric H Holbrook, MD, MEEI
Publications and helpful links
General Publications
- Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
- Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726.
- Lehmann AE, Raquib AR, Siddiqi SH, Meier J, Durand ML, Gray ST, Holbrook EH. Prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis: a randomized, double-blind, placebo-controlled noninferiority clinical trial. Int Forum Allergy Rhinol. 2021 Jul;11(7):1047-1055. doi: 10.1002/alr.22756. Epub 2020 Dec 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Sinusitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Amoxicillin
- Clavulanic Acid
- Clavulanic Acids
- Amoxicillin-Potassium Clavulanate Combination
Other Study ID Numbers
- 11-053H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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