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This prospective randomized controlled trial evaluates the effectiveness and safety of different nasal irrigation solutions for postoperative care after endoscopic sinus surgery in patients with chronic rhinosinusitis. Patients undergoing endoscopic sinus surgery will be randomly assigned to receive nasal irrigation with normal saline, mucomyst, or diluted povidone-iodine solution for three months after surgery. Clinical outcomes, symptom scores, endoscopic findings, and potential ototoxic effects will be evaluated to compare the effectiveness and safety of these irrigation methods.
Chronic rhinosinusitis is a common inflammatory disease characterized by symptoms such as nasal obstruction, nasal discharge, facial pressure, and decreased sense of smell. Endoscopic sinus surgery (ESS) is often performed in patients whose symptoms do not improve with medical treatment. Postoperative nasal irrigation is widely used to promote mucosal healing and remove secretions in the nasal cavity and paranasal sinuses.
Povidone-iodine has broad-spectrum antimicrobial activity and is commonly used as a disinfectant. It has been suggested that diluted povidone-iodine solution may improve postoperative wound healing and provide additional antimicrobial effects when used as a nasal irrigation solution. However, concerns exist regarding the potential ototoxicity of povidone-iodine if it enters the middle ear during irrigation.
This prospective randomized controlled trial aims to evaluate the effectiveness and safety of nasal irrigation using normal saline, mucomyst, or diluted povidone-iodine solution after endoscopic sinus surgery in patients with chronic rhinosinusitis. Patients will receive nasal irrigation for three months after surgery. Clinical outcomes, symptom scores, endoscopic findings, and hearing-related tests including pure tone audiometry, tympanometry, and distortion product otoacoustic emissions will be evaluated to assess treatment effectiveness and potential ototoxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline Irrigation | Active Comparator | Patients perform nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery. |
|
| Mucomyst Irrigation | Active Comparator | Patients perform nasal irrigation using a mucomyst solution for 3 months after endoscopic sinus surgery. |
|
| Povidone-Iodine Irrigation | Experimental | Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution after endoscopic sinus surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline Nasal Irrigation | Other | Postoperative nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lund-Kennedy Endoscopic Score | Postoperative sinonasal status evaluated by nasal endoscopy using the Lund-Kennedy endoscopic scoring system. | 3 months after endoscopic sinus surgery |
| Hearing function assessed by pure tone audiometry (PTA) | Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions. | 3 months after endoscopic sinus surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-20) score | Patient-reported sinonasal symptoms and disease-specific quality of life assessed using the Sino-Nasal Outcome Test-20 questionnaire. | 3 months after endoscopic sinus surgery |
| Distortion Product Otoacoustic Emission (DPOAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Pusan | 49241 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31560120 | Background | Panchmatia R, Payandeh J, Al-Salman R, Kakande E, Habib AR, Mullings W, Javer AR. The efficacy of diluted topical povidone-iodine rinses in the management of recalcitrant chronic rhinosinusitis: a prospective cohort study. Eur Arch Otorhinolaryngol. 2019 Dec;276(12):3373-3381. doi: 10.1007/s00405-019-05628-w. Epub 2019 Sep 27. | |
| 32250552 |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D055556 | Nasal Lavage |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Acetylcysteine (Mucomyst) Nasal Irrigation | Drug | Postoperative nasal irrigation using acetylcysteine solution for 3 months after endoscopic sinus surgery. |
|
| Povidone-Iodine Nasal Irrigation | Drug | Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution for 3 months after endoscopic sinus surgery. |
|
Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions. |
| 3 months after endoscopic sinus surgery |
| Ramezanpour M, Smith JLP, Psaltis AJ, Wormald PJ, Vreugde S. In vitro safety evaluation of a povidone-iodine solution applied to human nasal epithelial cells. Int Forum Allergy Rhinol. 2020 Oct;10(10):1141-1148. doi: 10.1002/alr.22575. Epub 2020 Jun 7. |
| 32301284 | Background | Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18. |
| 32317139 | Background | Mady LJ, Kubik MW, Baddour K, Snyderman CH, Rowan NR. Consideration of povidone-iodine as a public health intervention for COVID-19: Utilization as "Personal Protective Equipment" for frontline providers exposed in high-risk head and neck and skull base oncology care. Oral Oncol. 2020 Jun;105:104724. doi: 10.1016/j.oraloncology.2020.104724. Epub 2020 Apr 16. No abstract available. |
| 25363372 | Background | Kim JH, Rimmer J, Mrad N, Ahmadzada S, Harvey RJ. Betadine has a ciliotoxic effect on ciliated human respiratory cells. J Laryngol Otol. 2015 Jan;129 Suppl 1:S45-50. doi: 10.1017/S0022215114002746. Epub 2014 Nov 3. |
| 29633177 | Background | Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9. |
| 26416214 | Background | Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28. |
| 32571829 | Background | Lepelletier D, Maillard JY, Pozzetto B, Simon A. Povidone Iodine: Properties, Mechanisms of Action, and Role in Infection Control and Staphylococcus aureus Decolonization. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00682-20. doi: 10.1128/AAC.00682-20. Print 2020 Aug 20. |
| 22311838 | Background | 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. |
| 9473061 | Background | Senior BA, Kennedy DW, Tanabodee J, Kroger H, Hassab M, Lanza D. Long-term results of functional endoscopic sinus surgery. Laryngoscope. 1998 Feb;108(2):151-7. doi: 10.1097/00005537-199802000-00001. |
| 32563787 | Background | Lee VS, Pottinger PS, Davis GE. Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis. Am J Otolaryngol. 2020 Sep-Oct;41(5):102604. doi: 10.1016/j.amjoto.2020.102604. Epub 2020 Jun 6. |
| 26467934 | Background | Zhao K, Craig JR, Cohen NA, Adappa ND, Khalili S, Palmer JN. Sinus irrigations before and after surgery-Visualization through computational fluid dynamics simulations. Laryngoscope. 2016 Mar;126(3):E90-6. doi: 10.1002/lary.25666. Epub 2015 Oct 15. |
| 34397104 | Background | Wu PH, Cheng PC, Chang CM, Lo WC, Cheng PW. Efficacy of Povidone-Iodine Nasal Irrigation Solution After Sinonasal Surgery: A Randomized Controlled Study. Laryngoscope. 2022 Jun;132(6):1148-1152. doi: 10.1002/lary.29818. Epub 2021 Aug 16. |
| 25832968 | Background | 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. |
| 29894317 | Background | Steele TO, Gill A, Tollefson TT. Contemporary considerations in concurrent endoscopic sinus surgery and rhinoplasty. Curr Opin Otolaryngol Head Neck Surg. 2018 Aug;26(4):209-213. doi: 10.1097/MOO.0000000000000469. |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |