Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients
NCT ID: NCT03303677
Last Updated: 2018-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
2018-04-01
2019-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
If the patient meets criteria, he/she will be approached by one of the investigators about participating in the research study. Information regarding the study, including the informed consent form, will be extensively discussed. If the patient agrees to take part in this study, the consent form will be provided for review and will then be signed. This consent form will be kept in a secure locked location with access given only to study staff identified in the Institutional Review Board (IRB) protocol. It will be explained to the patients that there is no obligation for them to participate in the study and that they can drop out of the study at any time without repercussions regarding their care.
If a patient elects to be a part of the study they will be randomized into one of three treatment arms. This process will be done by placing an equal number of note cards in envelopes. The note cards will contain either a "1", "2", or "3" to represent the different treatment arms. These will be placed in the envelopes, shuffled, and kept in a box in the otolaryngology clinic. At the patient's first postoperative appointment an envelope is drawn and it is documented which treatment arm the patient will be treated under.
All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. The first treatment arm will consist of patients that are given only saline nasal irrigations to be performed twice daily. The second arm will be given a prescription for nasal saline + budesonide to be performed twice daily. The final arm will be given a prescription for nasal saline + budesonide + a culture directed topical antibiotic. These treatments are commonly used in our practice and will be obtained through the compounding pharmacies that are already in use by our practice.
Patients will be seen in follow up at 1-2 week, 3-4 week, 6-8 week, and 10-12 week follow up appointments. At each of these appointments they will undergo nasal endoscopy and debridement as is standard following endoscopic sinus surgery. They will also be asked to fill out SNOT-22 and RSDI surveys to monitor their progression.
The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.
The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.
Endoscopy findings will be scored using the Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting . Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found.
Final data will compare the pre and postoperative SNOT-22 and RSDI surveys, endoscopy findings, need for oral antibiotics, and need for oral steroids for the three treatment arms.
Cultures will be obtained for all patients during endoscopic sinus surgery as is our standard practice. During treatment patients will be treated as per standard which could include the use of oral antibiotics, oral steroids, or nasal steroid sprays as their medical condition warrants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Saline
Post operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
Saline Nasal
topical nasal saline rinses
Saline and budesonide
Post operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
Saline Nasal
topical nasal saline rinses
Budesonide Nasal
saline + budesonide nasal saline irrigation
saline, budesonide, and topical antibiotic
Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
Saline Nasal
topical nasal saline rinses
Budesonide Nasal
saline + budesonide nasal saline irrigation
Topical Antibacterial (Product)
The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saline Nasal
topical nasal saline rinses
Budesonide Nasal
saline + budesonide nasal saline irrigation
Topical Antibacterial (Product)
The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* endoscopic sinus surgery for reason other than CRS
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeb Justice, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univeristy of Florida
Gainesville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
Rawal RB, Deal AM, Ebert CS Jr, Dhandha VH, Mitchell CA, Hang AX, Gore MR, Senior BA, Zanation AM. Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial. Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.
Lee VS, Davis GE. Culture-directed topical antibiotic treatment for chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):414-417. doi: 10.2500/ajra.2016.30.4380.
Lim M, Citardi MJ, Leong JL. Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008 Jul-Aug;22(4):381-9. doi: 10.2500/ajr.2008.22.3189.
Rudmik L, Smith TL. Evidence-based practice: postoperative care in endoscopic sinus surgery. Otolaryngol Clin North Am. 2012 Oct;45(5):1019-32. doi: 10.1016/j.otc.2012.06.006.
Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.
Kim ST, Sung UH, Jung JH, Paik JY, Woo JH, Cha HE, Kang IG. The effect of maxillary sinus irrigation on early prognostic factors after endoscopic sinus surgery: a preliminary study. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):e158-61. doi: 10.2500/ajra.2013.27.3967.
Giotakis AI, Karow EM, Scheithauer MO, Weber R, Riechelmann H. Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Rhinology. 2016 Dec 1;54(4):302-310. doi: 10.4193/Rhino16.026.
Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.
Jang DW, Lachanas VA, Segel J, Kountakis SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Sep;3(9):708-11. doi: 10.1002/alr.21189. Epub 2013 Jun 17.
Oakley GM, Harvey RJ. Topical Steroids. Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.
Wong KK, Marglani O, Westerberg BD, Javer AR. Systemic absorption of topical gentamicin sinus irrigation. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):395-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB201701952
Identifier Type: -
Identifier Source: org_study_id