Trial Outcomes & Findings for Use of Perioperative Antibiotics in Endoscopic Sinus Surgery (NCT NCT03369717)

Last Updated: 2025-06-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively

Results posted on

2025-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Antibiotics To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics	No Antibiotics Will not receive any postoperative antibiotics
Overall Study STARTED	12	12
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotics n=12 Participants To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics	No Antibiotics n=12 Participants Will not receive any postoperative antibiotics	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	52 Years n=5 Participants	46 Years n=7 Participants	49 Years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Active Infection at time of surgery	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively

Outcome measures

Outcome measures
Measure	Antibiotics n=12 Participants To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics	No Antibiotics n=12 Participants Will not receive any postoperative antibiotics
Postoperative Infection	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively

Population: The numbers reflect loss of follow up of patients during successive visits.

Postoperative SNOT-22 scores will be summarized for each visit based on patient-reported symptoms. The SNOT-22 is a 22-item questionnaire used to assess the impact of chronic rhinosinusitis (CRS) on a patient's health-related quality of life. Participants are presented with a list of symptoms and social/emotional consequences of rhinosinusitis and asked to rate each problem over the prior 2-week period on a 6-point Likert scale ranging from 0 ("No Problem") to 5 ("Problem as bad as it can be)" yielding an overall possible scoring range of 0-110. Higher scores are indicative of a greater burden CRS-related symptoms. Scores are summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	Antibiotics n=12 Participants To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics	No Antibiotics n=12 Participants Will not receive any postoperative antibiotics
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores 7 to 10 days post op	25 score on a scale Standard Deviation 2	22 score on a scale Standard Deviation 1
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores 2 to 4 weeks post op	23 score on a scale Standard Deviation 1.5	21 score on a scale Standard Deviation 0.5
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores 6 to 8 weeks post op	22 score on a scale Standard Deviation 0.5	21 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively

Population: The numbers reflect loss of follow up of patients during successive visits.

Sinonasal crusting and inflammation was determined using the perioperative sinus endoscopy (POSE) scoring system based on patient-reported symptoms obtained during all three study visits. POSE assigns points to various areas within the nasal passages, based on the presence of certain conditions like crusting, edema, polyps, secretions, etc. For purposes of this study each parameter was scored from 0-2 yielding an overall possible score of 0-10, with higher scores being indicative of more extensive disease severity or surgical extent in the sinuses. Scores are summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	Antibiotics n=12 Participants To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics	No Antibiotics n=12 Participants Will not receive any postoperative antibiotics
Perioperative Sinus Endoscopy (POSE) Scores 7 to 10 days post op	5.4 score on a scale Standard Deviation 1.4	5.2 score on a scale Standard Deviation 1.1
Perioperative Sinus Endoscopy (POSE) Scores 2 to 4 weeks post op	4.3 score on a scale Standard Deviation 0.6	4.1 score on a scale Standard Deviation 0.8
Perioperative Sinus Endoscopy (POSE) Scores 6 to 8 weeks post op	3.8 score on a scale Standard Deviation 0.2	3.5 score on a scale Standard Deviation 0.4

Adverse Events

Antibiotics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Antibiotics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nadeem Akbar MD

Montefiore Medical Center

Phone: 7189204646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place