NCT03369717|TerminatedPhase 4ResultsDMCFDA Drug
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Study terminated early
Sponsor study identifier
interventional
24
1 country
1
Study Start
August 1, 2018
Actual (reported)Primary Completion
May 7, 2020
Actual (reported)Study Completion
May 7, 2020
Actual (reported)The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 7, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 6, 2017
Actual (reported)December 12, 2017
Actual (reported)August 1, 2018
Actual (reported)May 7, 2020
Actual (reported)May 7, 2020
Actual (reported)June 17, 2025
Actual (reported)Postoperative Infection
The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms that there is an actual bacterial source of the infection.
During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores
During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Perioperative Sinus Endoscopy (POSE) Scores
During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
To receive postoperative antibiotics
Will not receive any postoperative antibiotics
Montefiore Medical Center
The Bronx, New York, 10467, United States
We had a very low enrollment and therefore were unable to reach any statistical significance with any of our endpoints.
Nadeem Akbar, MD
Assistant Professor
24 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2017
First Posted
December 12, 2017
Study Start
August 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 7, 2020
Actual (reported)Study Completion
May 7, 2020
Actual (reported)Last Updated
June 17, 2025
Results First Posted
June 17, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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