Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | August 1, 2018 |
| End Date: | July 2020 |
| Contact: | Nadeem A Akbar, MD |
| Email: | nakbar@montefiore.org |
| Phone: | 7189204646 |
The objective of this study is to determine whether the use of postoperative antibiotics
following 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.
following 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.
Inclusion Criteria:
- Patients with 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.
We found this trial at
1
site
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
