- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06316635
Microplastics in Otitis Media With Effusion Material
Evaluation of Microplastics Presence in Otitis Media With Effusion Material
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was planned prospectively. With ethical approvel, 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. Patients with craniofacial anomaly, cleft palate, had history of previous ear surgery were excluded. They were operated as paracentesis and ventilation tube implementation (VTI). An informed consent form was obtained from them and their parents.
Operation: Surgical indication was made according to disease duration and/or hearing loss. Patients were operated under general anesthesia. Paracentesis was made from posteroinferior quadrant of tympanic membrane. Glu material was trapped in the suction tube and tranferred to glass tubes immediately (Figure 1). For this, glass syringe and 0.9 % serum physiologic were used. Samples were sent from right and left ear seperately. Microplastics determination was made in Enviromental Engineering Labaratory of Faculty of Engineering.
Microplastics Determination Method: It applied according to Prada et. al report (11). 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 [16]: (i) incubation for 24 h at 60 °C (Oasis™ Benchtop IR CO2 Incubator, Caron, OH, USA) in 30 mL of 10% KOH (w/v, ≥85%, Labchem, PA, USA); (ii) at 24 h, the temperature was raised to boiling point and the solution immediately filtered on glass fiber filter membrane (1.2 µm pore, Whatman® GF/C, Little Chalfont, Buckinghamshire, UK) mounted in a vacuum glass filtration system; (iii) 100 mL of boiling filtered distilled water was filtered to remove soaps; (iv) 10 mL of acetone was added to the cup for 10 min; (v) an additional 10 mL of acetone was filtered to remove lipophilic matter; (vi) 0.5-1 mL of 0.01 mg mL-1 of Nile Red (microscopy grade, Sigma-Aldrich, St. Louis, MO, USA) was added to the cup for 5 min; (vii) 50 mL of distilled water was filtered; and (viii) stored in glass Petri dishes kept inside cardboard boxes for a week to dry at room temperature (20 °C).
Contamination Control Measures Strict contamination control measures were conducted in all phases, namely by: (i) wearing cotton lab coats and clean gloves; (ii) working in the laminar flow hood in a clean room, maintained by cleaning with ethanol in paper towels followed by cleaning with a duster that attracts and traps dust particles and paper fibers; (iii) filtering all solutions (1.2 µm pore, Whatman® GF/C); (iv) using glass and metal materials; (v) decontaminating glass materials by submerging them in 10% HNO3 for at least 30 min and rinsing with distilled water; (vi) additionally cleaning glass Petri dishes with a N2 air jet; (vii) burning glass microfiber filter membranes at 450 °C for 3 h; (viii) cleaning the cup of the filtration system between samples by dipping it for 15 s in a solution (first batch: acetone, second batch: 30% HNO3) followed by dipping in distilled water; (ix) keeping sample containers closed as much as possible with glass lids, caps, or aluminum foil; and (x) conducting procedural blanks (solutions without samples exposed to sample preparation procedures) for each batch. Each samples were tested by three times for verification. In addition, microplastics were evaluated in serum psyisologic to prevent contamination.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: KEREM KÖKOĞLU, Assoc Prof.
- Phone Number: +905352056780
- Email: dr.kokoglu@gmail.com
Study Locations
-
-
-
Kayseri, Turkey, 38039
- Recruiting
- Erciyes University Medical School
-
Contact:
- KEREM KÖKOĞLU
- Phone Number: 535-205-6780
- Email: dr.kokoglu@gmail.com
-
Contact:
- Onat B Taş, M.D.
- Phone Number: 90 505-702-2227
- Email: onat-berkay@hotmail.com
-
Sub-Investigator:
- Mehmet I Şahin, Assoc. Prof, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with craniofacial anomaly, cleft palate, had history of previous ear surgery were excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
a paracentesis will be done to tympanic membrane.
Glu will be aspirated and trapped.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microplastic presence
Time Frame: from March 2024 to April 2024
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet I Şahin, Assoc Prof., TC Erciyes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/209
- self-funding (Other Identifier: Erciyes University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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