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Otitis Media clinical trials

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NCT ID: NCT06100159 Completed - Quality of Life Clinical Trials

Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion

Start date: January 20, 2017
Phase: N/A
Study type: Interventional

The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. The main questions it aims to answer are: - Does tympanic tube insertion have an effect on sleep quality in children with chronic OME? - Does tympanic tube insertion improve the quality of life for the children with chronic OME and their caregivers? Participants will have their movements during sleep and number of awakenings measured by an accelerometer placed on their wrist for 7 nights before and after tympanic tube insertion. Their caregivers will answer questionnaires regarding quality of life on behalf of the child. Researchers will compare with a control group of children who also is diagnosed with chronic OME. They will also have their sleep monitored for 7 nights and their caregivers will complete quality of life questionnaires, but the will not receive a tympanic tube. However the control group will be reassessed a month after baseline, and if they still qualify for tympanic tube insertion they will undergo the same routine as the intervention group.

NCT ID: NCT05967845 Completed - Clinical trials for Chronic Suppurative Otitis Media

Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This study was performed to compare healing and hearing outcomes of two tympanoplasty techniques, performed for patients with total or subtotal tympanic membrane perforations. The first group underwent temporalis fascia tympanoplasty, augmented with platelet rich fibrin, while the second group underwent cartilage tympanoplasty. preoperative data, operative techniques, and postoperative outcomes were analyzed.

NCT ID: NCT05657717 Completed - Clinical trials for Chronic Suppurative Otitis Media

Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Start date: July 13, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Throughout history, honey has been recognized for its healing properties. The use of honey for its medicinal properties dates back to 2200 BCE. The purpose of this clinical trial is to learn about the otological safety of 100% Medical grade Manuka Honey given to tympanoplasty patients The main question it aims to answer is: Can 100% Medical Grade Manuka Honey given at the time of Tympanoplasty otologically safe? Participants in the intervention group will receive a wound dressing of 100% medical grade Manuka honey after reconstructive surgery of the tympanic membrane. Researchers will compare the intervention group to the control group assess otological safety.

NCT ID: NCT05605262 Completed - Clinical trials for Tympanic Membrane Perforation

Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.

Start date: June 13, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Throughout history, honey has been recognized for its healing properties. The use of honey for its medicinal properties dates back to 2200 BCE. The purpose of this clinical trial is to learn about the healing effects of 100% medical grade Manuka honey in participants with Chronic Suppurative Otitis Media of the mucosal type. The main question it aims to answer is: Can 100% Manuka honey given at the time of Tympanoplasty improve the re-epithelialization (healing process) of the tympanic membrane compared to controls? Participants in the intervention group will receive a wound dressing of 100% medical grade Manuka honey after reconstructive surgery of the tympanic membrane. Researchers will compare the intervention group to the control group to see healing process.

NCT ID: NCT05133258 Completed - Clinical trials for Chronic Suppurative Otitis Media

Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media

Start date: July 5, 2022
Phase:
Study type: Observational

The study team aims to elucidate the potential role of ototopical antibiotic concentration on outcomes in patients diagnosed with chronic suppurative otitis media (CSOM). Chronic suppurative otitis media (CSOM) is characterized by chronic inflammation of the middle ear with persistent discharge from a non-intact tympanic membrane. CSOM is notably associated with a significant burden of disease worldwide. Topical fluoroquinolones are first line therapy for CSOM and are advantageous as compared to oral or intravenous therapy in that these antibiotics avoid systemic side effects and have the potential to locally deliver high antibiotic concentrations, which were thought to be sufficient to overcome all bactericidal resistance to fluoroquinolones. The investigators will measure antibiotic concentration in aspirates via liquid chromatography with tandem mass spectrometry (LC-MS/MS) from the middle ear of selected subjects with CSOM who are prescribed and instructed to self-administer ototopical ciprofloxacin. Enrolled subjects will be asked to return 3 to 10 days after initial visit to aspirate the middle ear and receive a follow-up evaluation. Furthermore, the subjects will be asked to keep logs of their medication use and to administer the ototopical medication one hour prior to their appointments. The measured ciprofloxacin concentrations will be correlated with clinical outcomes, primarily the time to symptom resolution. The guiding hypothesis is that patient self-administration of ciprofloxacin drops vary in antibiotic delivery with diluted concentrations significantly below the in vitro concentration of the prescribed solution and that these concentrations are below the bactericidal concentration of ciprofloxacin-resistant bacteria.

NCT ID: NCT04864912 Completed - Clinical trials for Chronic Otitis Media

Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

Start date: February 1, 2022
Phase:
Study type: Observational

The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

NCT ID: NCT04752891 Completed - Clinical trials for Otitis Media, Suppurative

Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department

OMA-IA
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

NCT ID: NCT04722770 Completed - Otitis Media Acute Clinical Trials

Clinical Development of Deep Learning for the OtoSight

Start date: January 19, 2021
Phase:
Study type: Observational

The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.

NCT ID: NCT04600752 Completed - Clinical trials for Respiratory Tract Infections

Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India

Start date: January 12, 2022
Phase: Phase 4
Study type: Interventional

Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses. Most physicians in India use the standard Augmentin (amoxicillin:clavulanic acid 7:1) (45/6.4 mg/kg/day) formulation and double the dose to achieve higher dose of amoxicillin/clavulanic acid at 90 mg/kg/day in pediatric acute otitis media (AOM) due to non-availability of Augmentin (ES)-600. Using the 7:1 formulation causes unnecessary exposure to higher proportionate dose of clavulanic acid (12.8 mg/kg/day) as a unit dose of 6.4 mg/kg/day of clavulanic acid is only required for efficacy against beta-lactamase producing AOM pathogens. Hence, there is an unmet need for availability of Augmentin (ES)-600 in India. This is an open label, single arm, multicenter, non-comparative study in participants aged 6 months to 12 years with AOM. It aims to assess the safety and clinical efficacy of Augmentin (ES)-600 administered in two divided doses, every 12 hours in pediatric population in India. AUGMENTIN is a registered trademark of the GlaxoSmithKline group of companies.

NCT ID: NCT04588376 Completed - Acute Otitis Media Clinical Trials

Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Findings from an ongoing improvement project to improve antibiotic prescribing for children and adolescents for three acute respiratory tract infections (ARTIs: upper respiratory tract infection, acute bacterial sinusitis, and acute otitis media) among pediatric and family medicine clinics revealed performance gaps between the two primary care specialties. An improvement project was then set up to address the lower performance by family medicine clinics. Literature review revealed that, in general, quality improvement feedback was more effective if provided to individual clinicians rather than to a group of clinicians, but very limited data existed for antibiotic prescribing practices actually comparing individual clinician feedback to group (clinic-level) feedback. The hypothesis is that individual clinician data feedback is superior to group (clinic-level) feedback in improving antibiotic prescribing for ARTIs in children and adolescents by family medicine clinicians. The aim is to determine if there are significant differences for antibiotic prescribing for ARTIs and for broad spectrum antibiotic prescribing percentage between an intervention group and a comparator group of family medicine clinics after the intervention starting November 2015 and ending December 2018. A cluster randomized trial was designed for 39 family medicine clinics. The intervention group received clinician-level and clinic-level data feedback monthly, and the comparator group received clinic-level only feedback monthly.