Microplastics in Otitis Media With Effusion Material
Evaluation of Microplastics Presence in Otitis Media With Effusion Material
2 other identifiers
observational
40
1 country
1
Brief Summary
Microplastic rate is increasing ib athmosphere. They can be found in lung, kidney, heart, even placenta. Otitis media with effusion (OME) is a clinical condition that is ver common in children. Biofilms are blamed in the pathogenesis of OME. Microplastics can include biofilms. Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies. This study aims to investigate presency of microplastics in middle ear fluid of patients with OME.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2024
CompletedMarch 27, 2024
March 1, 2024
1 month
March 10, 2024
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microplastic presence
They will be commented as yes / no. Microplastics Determination Method: It applied according to Prada et. al report. Fragments, except blood clots, were washed with a jet of filtered distilled water inside the laminar flow hood to remove any surface contamination and all samples were weighed inside closed glass flasks to the nearest 0.1 mg (Sartorius, Entris, Germany). A method for preparing biological samples for Nile Red staining, previously developed and tested, was followed.
from March 2024 to April 2024
Study Arms (1)
patient group
patient group has formed as operated patients because of OME A paracentesis and ventilation tube insertion will be performed them. After paracentesis, effusion otitis media will be trapped and sampled for microplastic analysis.
Interventions
a paracentesis will be done to tympanic membrane. Glu will be aspirated and trapped.
Eligibility Criteria
Any age, patients with bilateral OME at least 3 months or unilateral OME at least 9 months
You may qualify if:
- patients who were followed by bilateral OME at least for three months or one-sided OME at least for 9 months were enrolled to the study
You may not qualify if:
- Patients with craniofacial anomaly, cleft palate, had history of previous ear surgery were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kerem Kökoğlulead
Study Sites (1)
Erciyes University Medical School
Kayseri, 38039, Turkey (Türkiye)
Related Publications (1)
Kokoglu K, Mihciokur H, Uyanik I, Ozturk D, Yildiz H, Tas OB, Kaplan RA. Microplastic presence in the fluid of otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2025 Sep;196:112501. doi: 10.1016/j.ijporl.2025.112501. Epub 2025 Jul 30.
PMID: 40753682DERIVED
Biospecimen
effusion of otitis media
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehmet I Şahin, Assoc Prof.
TC Erciyes University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 40 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 18, 2024
Study Start
March 20, 2024
Primary Completion
April 20, 2024
Study Completion
April 20, 2024
Last Updated
March 27, 2024
Record last verified: 2024-03