Chronic Sinus Infection
Conditions
Keywords
endoscopic sinus surgery, antibiotics
Brief summary
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.
Interventions
Postoperative antibiotics
Sponsors
Mount Sinai Hospital, New York
NYU Langone Health
Weill Medical College of Cornell University
Columbia University
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with Chronic Rhinosinusitis (CRS) with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included.
Exclusion criteria
* Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Infection | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Perioperative Sinus Endoscopy (POSE) Scores | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antibiotics To receive postoperative antibiotics
Amoxi Clavulanate: Postoperative antibiotics | 12 |
| No Antibiotics Will not receive any postoperative antibiotics | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Antibiotics | No Antibiotics | Total |
|---|---|---|---|
| Active Infection at time of surgery | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Continuous | 52 Years | 46 Years | 49 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 4 Participants | 11 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antibiotics | Postoperative Infection | 1 Participants |
| No Antibiotics | Postoperative Infection | 0 Participants |
Secondary
Perioperative Sinus Endoscopy (POSE) Scores
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics | Perioperative Sinus Endoscopy (POSE) Scores | 6 to 8 weeks post op | 3.8 score on a scale | Standard Deviation 0.2 |
| Antibiotics | Perioperative Sinus Endoscopy (POSE) Scores | 7 to 10 days post op | 5.4 score on a scale | Standard Deviation 1.4 |
| Antibiotics | Perioperative Sinus Endoscopy (POSE) Scores | 2 to 4 weeks post op | 4.3 score on a scale | Standard Deviation 0.6 |
| No Antibiotics | Perioperative Sinus Endoscopy (POSE) Scores | 6 to 8 weeks post op | 3.5 score on a scale | Standard Deviation 0.4 |
| No Antibiotics | Perioperative Sinus Endoscopy (POSE) Scores | 7 to 10 days post op | 5.2 score on a scale | Standard Deviation 1.1 |
| No Antibiotics | Perioperative Sinus Endoscopy (POSE) Scores | 2 to 4 weeks post op | 4.1 score on a scale | Standard Deviation 0.8 |
Secondary
Postoperative Sino-nasal Outcome Test (SNOT-22) Scores
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | 7 to 10 days post op | 25 score on a scale | Standard Deviation 2 |
| Antibiotics | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | 2 to 4 weeks post op | 23 score on a scale | Standard Deviation 1.5 |
| Antibiotics | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | 6 to 8 weeks post op | 22 score on a scale | Standard Deviation 0.5 |
| No Antibiotics | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | 6 to 8 weeks post op | 21 score on a scale | Standard Deviation 0.5 |
| No Antibiotics | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | 7 to 10 days post op | 22 score on a scale | Standard Deviation 1 |
| No Antibiotics | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | 2 to 4 weeks post op | 21 score on a scale | Standard Deviation 0.5 |